Trial Outcomes & Findings for Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease (NCT NCT00719888)

NCT ID: NCT00719888

Last Updated: 2025-03-07

Results Overview

Overall survival defined as patient being alive at 1 year post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

135 participants

Primary outcome timeframe

1 year post-transplant

Results posted on

2025-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Thiotepa: Given IV
Overall Study STARTED	108	27
Overall Study Started: Single-cord Transplant	34	17
Overall Study Started: Double-cord Transplant	74	10
Overall Study Completed: Single-cord Transplant	26	10
Overall Study Completed: Double-cord Transplant	48	5
Overall Study COMPLETED	74	15
Overall Study NOT COMPLETED	34	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Thiotepa: Given IV
Overall Study Death	24	9
Overall Study Relapse	8	3
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Umbilical Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With Hematologic Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide n=108 Participants Patients enrolled to receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients to receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT (either single- or double-cord)	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa n=27 Participants Patients enrolled to receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients to receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT (either single- or double-cord) Thiotepa: Given IV	Total n=135 Participants Total of all reporting groups
Age, Categorical <=18 years	52 Participants n=5 Participants	14 Participants n=7 Participants	66 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants	13 Participants n=7 Participants	69 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	22 years n=5 Participants	24.5 years n=7 Participants	22.5 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	14 Participants n=7 Participants	59 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	13 Participants n=7 Participants	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants	4 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=5 Participants	23 Participants n=7 Participants	96 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants	17 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	1 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year post-transplant

Population: Analysis population is all patients who underwent UCB transplant on study, whether completed treatment on study or relapsed at later timepoint.

Overall survival defined as patient being alive at 1 year post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.

Outcome measures

Outcome measures
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant n=33 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant n=17 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant n=72 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant n=10 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
Overall Survival	28 Participants	15 Participants	53 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline up to 2 years post-transplant

Population: Participants who received UCBT on study with chimerism data available within window as specified in protocol.

Peripheral blood chimerism studies (sorted for CD3, CD14, CD33, CD56 cells) were collected for all UCBT recipients for days 28, 56, 80, 365, and 730 post-transplant. The combined median of the percent donor, along with full range, is captured to show change in level of chimerism at multiple time points up to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.

Outcome measures

Outcome measures
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant n=33 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant n=17 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant n=72 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant n=10 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
Change in Level of Chimerism at Multiple Time Points Combined median of CD3 at days (24, 56, 80, 180, 365, 730)	100 percentage chimerism (%) Interval 44.0 to 100.0	100 percentage chimerism (%) Interval 69.0 to 100.0	100 percentage chimerism (%) Interval 67.0 to 100.0	100 percentage chimerism (%) Interval 88.0 to 100.0
Change in Level of Chimerism at Multiple Time Points Combined median of CD14 at days (24, 56, 80, 180, 365, 730)	100 percentage chimerism (%) Interval 0.0 to 100.0	100 percentage chimerism (%) Interval 100.0 to 100.0	100 percentage chimerism (%) Interval 91.0 to 100.0	100 percentage chimerism (%) Interval 100.0 to 100.0
Change in Level of Chimerism at Multiple Time Points Combined median of CD33 at days (24, 56, 80, 180, 365, 730)	100 percentage chimerism (%) Interval 99.0 to 100.0	100 percentage chimerism (%) Interval 98.0 to 100.0	100 percentage chimerism (%) Interval 50.0 to 100.0	100 percentage chimerism (%) Interval 91.0 to 100.0
Change in Level of Chimerism at Multiple Time Points Combined median of CD56 at days (24, 56, 80, 180, 365, 730)	100 percentage chimerism (%) Interval 0.0 to 100.0	100 percentage chimerism (%) Interval 100.0 to 100.0	100 percentage chimerism (%) Interval 60.0 to 100.0	100 percentage chimerism (%) Interval 90.0 to 100.0

SECONDARY outcome

Timeframe: At 6 months post-transplant

Population: Analysis population is all patients who underwent UCB transplant on study.

Defined as death due to complication (other than relapse) within 6 months following UCBT. Monitoring will take place separately for the single and double UCBT cohorts.

Outcome measures

Outcome measures
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant n=33 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant n=17 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant n=72 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant n=10 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
Incidence of Transplant-related Mortality (TRM)	2 Participants	1 Participants	9 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to day 42 post-transplant

Population: Analysis population is all patients who underwent UCB transplant and experienced ANC engraftment by day 42 post-transplant on study. 4 patients did engraft ANC after day 42 post-transplant, but are not included in this analysis due to protocol definition of engraftment period.

Neutrophil engraftment after UCBT is defined as the first day of absolute neutrophil count (ANC) ≥ 5 x 10⁸/L for 3 consecutive measures. Monitoring will take place separately for the single and double UCBT cohorts.

Outcome measures

Outcome measures
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant n=30 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant n=16 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant n=65 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant n=8 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
Neutrophil Engraftment	19 Days post-transplant Interval 12.0 to 42.0	19 Days post-transplant Interval 13.0 to 40.0	22 Days post-transplant Interval 12.0 to 39.0	20 Days post-transplant Interval 15.0 to 29.0

SECONDARY outcome

Timeframe: Up to 6 months post-transplant

Population: Analysis population is all patients who underwent UCB transplant and experienced PLT engraftment by 6 months post-transplant on study.

Platelet (PLT) engraftment after UCBT is defined as the first day of platelet count \> 20,000/μl without subsequent transfusions for 7 days. Monitoring will take place separately for the single and double UCBT cohorts.

Outcome measures

Outcome measures
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant n=29 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant n=16 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant n=60 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant n=8 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
Platelet Engraftment	34 Days post-transplant Interval 21.0 to 82.0	35 Days post-transplant Interval 18.0 to 90.0	41 Days post-transplant Interval 22.0 to 158.0	37 Days post-transplant Interval 30.0 to 56.0

SECONDARY outcome

Timeframe: Up to day 100 post-transplant

Population: Participants who received UCBT on study.

Each event of aGVHD will be assigned an overall aGVHD score based on extent of skin rash, volume of diarrhea, and maximum bilirubin level, per protocol Appendix I, "GVHD Staging and Grading." Scores reported range from most mild at 2, to worse at 4. Monitoring will take place separately for the single and double UCBT cohorts.

Outcome measures

Outcome measures
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant n=33 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant n=17 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant n=72 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant n=10 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
Event of Grade II-IV and III-IV Acute Graft-versus-host Disease (aGVHD) Grade II-IV aGVHD	29 events	14 events	51 events	5 events
Event of Grade II-IV and III-IV Acute Graft-versus-host Disease (aGVHD) Grade III-IV aGVHD	7 events	2 events	17 events	1 events

SECONDARY outcome

Timeframe: Up to 2 years post-transplant

Population: Participants who received UCBT on study.

Each event of cGVHD level will be assessed overall as either 'Limited' (mild and with single organ involvement) or 'Extensive' (involvement of two or more organs with symptoms) based on extent of skin rash, volume of diarrhea, and maximum bilirubin level, per protocol Appendix I, "GVHD Staging and Grading." Monitoring will take place separately for the single and double UCBT cohorts.

Outcome measures

Outcome measures
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant n=33 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant n=17 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant n=72 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant n=10 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
Event of Chronic Graft-verses-host-disease (cGVHD) Limited cGVHD	12 events	6 events	11 events	5 events
Event of Chronic Graft-verses-host-disease (cGVHD) Extensive cGVHD	14 events	5 events	44 events	2 events

SECONDARY outcome

Timeframe: Up to 2 years post-transplant

Population: Participants who received UCBT on study.

Each event of infection will be assessed to determine whether or not it is clinically significant. An infection is defined as clinically significant when it is scored as ≥ grade 3 (where worse outcomes are associated with higher grading) in accordance with the CTCAE version 3.0/protocol Appendix VI, and constitutes a Serious Adverse Event (SAE). Monitoring will take place separately for the single and double UCBT cohorts.

Outcome measures

Outcome measures
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant n=33 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant n=17 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant n=72 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant n=10 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
Event of Clinically Significant Infections	2 events	0 events	21 events	1 events

SECONDARY outcome

Timeframe: At 1 and 2 years post-transplant

Population: Analysis population is all patients who underwent UCB transplant on study.

Relapse is defined as post-transplant disease recurrence in participants who had initially recovered or improved, with incidence measured from Day 0 to 1 year post-transplant, and from 1 year post-transplant to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts.

Outcome measures

Outcome measures
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant n=33 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant n=17 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant n=72 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant n=10 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
Incidence of Relapse Relapse at 1 year	2 Participants	4 Participants	11 Participants	0 Participants
Incidence of Relapse Relapse at 2 year	0 Participants	0 Participants	0 Participants	1 Participants
Incidence of Relapse No relapse while on study	31 Participants	13 Participants	61 Participants	9 Participants

SECONDARY outcome

Timeframe: Up to 2 years post-transplant

Population: Analysis population is all patients who underwent UCB transplant on study.

PFS is defined as the time (in days) from UCBT until the disease progresses or the patient dies from any cause, with incidence measured up to 2 years post-transplant. Monitoring will take place separately for the single and double UCBT cohorts. Measure will be reported as the median amount of days from full minimum and maximum range.

Outcome measures

Outcome measures
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Single-cord Transplant n=33 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Single-cord Transplant n=17 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide; Double-cord Transplant n=72 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo high-dose TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa; Double-cord Transplant n=10 Participants Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo double-unit UCBT on day 0. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclosporine: Given IV and PO Mycophenolate Mofetil: Given IV and PO Laboratory Biomarker Analysis: Correlative studies
Progression-free Survival (PFS)	167 Days post-transplant Interval 90.0 to 181.0	155 Days post-transplant Interval 32.0 to 194.0	112 Days post-transplant Interval 6.0 to 353.0	317 Days post-transplant Interval 55.0 to 724.0

Adverse Events

Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide

Serious events: 47 serious events

Other events: 73 other events

Deaths: 24 deaths

Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa

Serious events: 7 serious events

Other events: 25 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Ann Dahlberg

Fred Hutchinson Cancer Center

Phone: 206-667-1959

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Regimen A: High-dose TBI + Fludarabine + Cyclophosphamide n=108 participants at risk Patients receive myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 and -6, and undergo high-dose TBI BID on days -4 to -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT	Regimen B: Middle-intensity TBI + Fludarabine + Cyclophosphamide + Thiotepa n=27 participants at risk Patients receive myeloablative conditioning comprising fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 2-4 hours on days -5 and -4, and middle-intensity TBI QD on days -2 and -1. Patients then undergo single- or double-unit UCBT on day 0. Patients receive GVHD prophylaxis comprising cyclosporine IV over 1 hour every 8 or 12 hours, then cyclosporine PO (if tolerated), on days -3 to 100 with taper on day 101. Patients also receive mycophenolate mofetil IV every 8 hours on days 0 to 7 and then PO (if tolerated) TID on days 8-30. Mycophenolate mofetil is tapered to BID on day 30 or 7 days after engraftment if there is no acute GVHD, and then tapered over 2-3 weeks beginning on day 45 (or 15 days after engraftment if engraftment occurred \> day 30) after engraftment if there continues to be no evidence of acute GVHD. Cyclophosphamide: Given IV Cyclosporine: Given IV and PO Double-Unit Umbilical Cord Blood Transplantation: Undergo double-unit UCBT Fludarabine: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV and PO Total-Body Irradiation: Undergo high-dose or moderate-intensity TBI Umbilical Cord Blood Transplantation: Undergo UCBT Thiotepa: Given IV
Immune system disorders Allergic reaction/hypersensitivity	1.9% 2/108 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	3.7% 1/27 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Febrile neutropenia	30.6% 33/108 • Number of events 50 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	51.9% 14/27 • Number of events 14 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Blood and lymphatic system disorders CD4 count	1.9% 2/108 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Leukocytes	0.93% 1/108 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Hemolysis	4.6% 5/108 • Number of events 5 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Iron overload	1.9% 2/108 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	3.7% 1/27 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Cardiac disorders Supraventricular and nodal arrhythmia	1.9% 2/108 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	7.4% 2/27 • Number of events 3 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Cardiac disorders Prolonged QTc interval	0.93% 1/108 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	7.4% 2/27 • Number of events 3 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Cardiac disorders Cardiac General - Other (Heart failure)	0.93% 1/108 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Cardiac disorders Hypertension	12.0% 13/108 • Number of events 15 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	40.7% 11/27 • Number of events 13 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Hypotension	9.3% 10/108 • Number of events 12 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	14.8% 4/27 • Number of events 5 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Cardiac disorders Cardiac ischemia/infarction	0.00% 0/108 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	3.7% 1/27 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Cardiac disorders Cardiac troponin I (cTnI)	0.93% 1/108 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Cardiac disorders Pericardial effusion	0.93% 1/108 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Coagulation, Other (Coagulopathy)	1.9% 2/108 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Blood and lymphatic system disorders Thrombotic microangiopathy (TMA)	2.8% 3/108 • Number of events 3 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	3.7% 1/27 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
General disorders Fatigue	1.9% 2/108 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	3.7% 1/27 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
General disorders Insomnia	0.93% 1/108 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
General disorders Fever	2.8% 3/108 • Number of events 3 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	7.4% 2/27 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Rash/desquamation	54.6% 59/108 • Number of events 77 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	40.7% 11/27 • Number of events 13 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Gastrointestinal disorders Nausea	3.7% 4/108 • Number of events 4 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	7.4% 2/27 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Gastrointestinal disorders Mucositis	29.6% 32/108 • Number of events 55 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	33.3% 9/27 • Number of events 9 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Renal and urinary disorders Acute kidney injury (AKI)	1.9% 2/108 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	11.1% 3/27 • Number of events 4 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Investigations Alanine aminotransferase (ALT) increased, SGPT (serum glutamic pyruvic transaminase)	2.8% 3/108 • Number of events 6 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Gastrointestinal disorders Anorexia	8.3% 9/108 • Number of events 10 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	18.5% 5/27 • Number of events 6 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome (ARDS)	0.93% 1/108 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Gastrointestinal disorders Ascites	0.00% 0/108 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	3.7% 1/27 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Investigations Aspartate aminotransferase increased (AST)	1.9% 2/108 • Number of events 3 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Osteonecrosis (avascular necrosis)	0.93% 1/108 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Investigations Hyperbilirubinemia	9.3% 10/108 • Number of events 14 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	11.1% 3/27 • Number of events 3 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Infections and infestations Cytomegalovirus virus (CMV) reactivation	4.6% 5/108 • Number of events 9 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	14.8% 4/27 • Number of events 4 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Renal and urinary disorders Cystitis	0.93% 1/108 • Number of events 3 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Vascular disorders Thrombosis/thrombus/ embolism	0.93% 1/108 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Psychiatric disorders Mood alteration - Depression	1.9% 2/108 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Gastrointestinal disorders Diarrhea	6.5% 7/108 • Number of events 18 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	18.5% 5/27 • Number of events 5 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Infections and infestations Disseminated Adenovirus (ADV)	5.6% 6/108 • Number of events 9 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Nervous system disorders Encephalopathy	1.9% 2/108 • Number of events 2 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	3.7% 1/27 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Gastrointestinal disorders Gastritis	2.8% 3/108 • Number of events 4 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	0.00% 0/27 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Renal and urinary disorders Renal/Genitourinary, Other (Veno-occlusive disease [VOD])	2.8% 3/108 • Number of events 4 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	3.7% 1/27 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.
Renal and urinary disorders Hematuria	0.93% 1/108 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.	3.7% 1/27 • Number of events 1 • Grade 3 or 4 (or highly unusual grade 2) adverse events were monitored, assessed, and collected from the start of study treatment (pre-transplant conditioning) through Day +100 post-transplant. All-Cause Mortality was monitored/assessed from the start of study treatment (pre-transplant conditioning) up to 2 years post-transplant. If a patient experiences relapse or graft failure and goes on to further treatment off protocol, adverse events are no longer collected with the exception of death. For the purpose of this study, hospitalizations for protocol-scheduled procedures, blood product transfusions, or for social reasons (i.e., awaiting transport home) will not be considered serious adverse events. Hospitalization will be considered a serious adverse event (SAE) if it is unexpected or the duration of the hospital stay is unexpected. Otherwise, the definition of adverse event and/or serious adverse event aligns with the clinicaltrials.gov definitions.