Trial Outcomes & Findings for Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers (NCT NCT04083170)

Last Updated: 2025-01-01

Results Overview

Will be defined by no neutrophil recovery by day 45 (regardless of donor chimerism) or autologous recovery (neutrophil recovery but \< 10% donor chimerism in blood and bone marrow) by day 36. This outcome was originally intended to be assessed for per the aforementioned definitions, but was only able to be assessed through 35 days post-transplant.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to day 35 post-transplant

Results posted on

2025-01-01

Participant Flow

Participant milestones

Participant milestones
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Followed by Unmanipulated Cord Blood and Dilanubicel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1 (totaling 1320 cGy). Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anti-cancer Drugs Plus TBI, Followed by Unmanipulated Cord Blood and Dilanubicel) Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1 (totaling 400 cGy). Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Overall Study STARTED	0	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cord Blood Transplant With Dilanubicel for the Treatment of HIV Positive Hematologic Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Followed by Unmanipulated Cord Blood and Dilanubicel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1 (totaling 1320 cGy). Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anti-cancer Drugs Plus TBI, Followed by Unmanipulated Cord Blood and Dilanubicel) n=1 Participants Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1 (totaling 400 cGy). Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	—	21 years n=7 Participants	21 years n=5 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	1 participants n=7 Participants	1 participants n=5 Participants
Matched cord blood unit with either homozygous or heterozygous CCR5Δ32 mutation. Homozygous CCR5Δ32 Mutation in CBU	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Matched cord blood unit with either homozygous or heterozygous CCR5Δ32 mutation. Heterozygous CCR5Δ32 Mutation in CBU	—	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to day 35 post-transplant

Population: No participants were enrolled to Regimen A of the study.

Outcome measures

Outcome measures
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Dilanubcel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anticancer Drugs, TBI, Dilanubicel) n=1 Participants Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Primary Graft Failure Rejection	—	0 Participants

SECONDARY outcome

Timeframe: Within the first 24 hours after infusion

Population: No participants were enrolled to Regimen A of the study.

Defined as Common Terminology Criteria for Adverse Events version 5.0 grade \>= 3 events.

Outcome measures

Outcome measures
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Dilanubcel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anticancer Drugs, TBI, Dilanubicel) n=1 Participants Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Incidence of Infusion Toxicities	—	0 infusion toxicity events

SECONDARY outcome

Timeframe: Up to Day 35 post-transplant

Population: No participants were enrolled to Regimen A of the study.

Neutrophil recovery is defined as the first day of 2 consecutive days of absolute neutrophil count \>= 500 after the first post-cord blood transplant nadir. This outcome was originally intended to be assessed for up to 45 days post-transplant, but was only able to be assessed through 35 days post-transplant.

Outcome measures

Outcome measures
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Dilanubcel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anticancer Drugs, TBI, Dilanubicel) n=1 Participants Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Median Number of Days Post-Transplant to Neutrophil Recovery Occurred	—	16 Days post-transplant Interval 16.0 to 16.0

SECONDARY outcome

Timeframe: 35 days post-transplant

Population: No participants were enrolled to Regimen A of the study. The single Regimen B participant did not achieve platelet engraftment prior to death on Day +35 post-transplant.

Will be defined as the first day of a platelet count \> 20,000/ul with subsequent transfusions for 7 days. This outcome was originally intended to be assessed for up to 2 years post-transplant, but was only able to be assessed through 35 days post-transplant.

Outcome measures

Outcome measures
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Dilanubcel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anticancer Drugs, TBI, Dilanubicel) n=1 Participants Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Platelet Engraftment	—	0 Participants

SECONDARY outcome

Timeframe: 35 days post-transplant

Population: No participant was enrolled to Regimen A of the study.

Will be defined by the 2014 National Institutes of Health (NIH) criteria. This outcome was originally intended to be assessed for up to 2 years post-transplant, but was only able to be assessed through 35 days post-transplant.

Outcome measures

Outcome measures
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Dilanubcel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anticancer Drugs, TBI, Dilanubicel) n=1 Participants Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Incidence of Severe (Grades III-IV) Acute Graft Versus Host Disease (GVHD)	—	0 Number of Grade 3/4 aGVHD Events

SECONDARY outcome

Timeframe: 35 days post-transplant

Population: No participants were enrolled to Regimen A of the study.

Will be defined by the 2014 NIH criteria. This outcome was originally intended to be assessed for up to 2 years post-transplant, but was only able to be assessed through 35 days post-transplant.

Outcome measures

Outcome measures
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Dilanubcel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anticancer Drugs, TBI, Dilanubicel) n=1 Participants Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Incidence of Chronic GVHD	—	0 Number of cGVHD Events

SECONDARY outcome

Timeframe: 35 days post-transplant

Population: No participants were enrolled to Regimen A of the study.

Will be defined as death without a prior relapse. This outcome was originally intended to be assessed for up to 180 days post-transplant, but was only able to be assessed through 35 days post-transplant.

Outcome measures

Outcome measures
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Dilanubcel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anticancer Drugs, TBI, Dilanubicel) n=1 Participants Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Incidence of Non-relapse Mortality	—	1 Participants

SECONDARY outcome

Timeframe: Baseline and weekly to 35 days post-transplant

Population: No participants were enrolled to Regimen A of the study.

Assess CCR5Δ32 cord blood stem cell engraftment and its effect on biomarkers of HIV-1 infection, including plasma viral load and replication-competent reservoirs, as well as in gut and other sites (if tissue samples are available). This outcome was originally intended to be assessed weekly for up to 2 years post-transplant, but was only able to be assessed through 35 days post-transplant.

Outcome measures

Outcome measures
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Dilanubcel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anticancer Drugs, TBI, Dilanubicel) n=1 Participants Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1. Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Human Immunodeficiency Virus (HIV) Plasma Viral Load	—	0 percentage of viral load change

Adverse Events

Regimen A (Fludarabine, Cyclophosphamide, TBI, Followed by Unmanipulated Cord Blood and Dilanubicel)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Regimen B (Anti-cancer Drugs Plus TBI, Followed by Unmanipulated Cord Blood and Dilanubicel)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Followed by Unmanipulated Cord Blood and Dilanubicel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1 (totaling 1320 cGy). Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anti-cancer Drugs Plus TBI, Followed by Unmanipulated Cord Blood and Dilanubicel) n=1 participants at risk Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1 (totaling 400 cGy). Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Hepatobiliary disorders Hepatobiliary disorders - Other, Liver insufficiency	— 0/0 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.	100.0% 1/1 • Number of events 1 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.
Renal and urinary disorders Renal and urinary disorders - Other, Renal insufficiency	— 0/0 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.	100.0% 1/1 • Number of events 1 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.
Nervous system disorders Posterior Reversible Encephalopathy Syndrome (PRES)	— 0/0 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.	100.0% 1/1 • Number of events 1 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.

Other adverse events

Other adverse events
Measure	Regimen A (Fludarabine, Cyclophosphamide, TBI, Followed by Unmanipulated Cord Blood and Dilanubicel) Patients receive fludarabine IV over 30 minutes on days -8 to -6, cyclophosphamide IV on days -7 to -6, and undergo TBI BID on days -4 to -1 (totaling 1320 cGy). Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV	Regimen B (Anti-cancer Drugs Plus TBI, Followed by Unmanipulated Cord Blood and Dilanubicel) n=1 participants at risk Patients receive fludarabine IV over 30-60 minutes on days -6 to -2, cyclophosphamide IV on day -6, thiotepa IV over 4 hours on days -5 to -4, and undergo TBI QD on days -2 to -1 (totaling 400 cGy). Patients then undergo umbilical cord blood transplant on day 0. Between 4-24 hours after transplant completion, patients receive dilanubicel IV over 5-10 minutes in the absence of disease progression or unacceptable toxicity. Fludarabine: Given IV Cyclophosphamide: Given IV Thiotepa: Given IV Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo UCBT Dilanubicel: Given IV
Infections and infestations Sepsis (Strep mitis + Strep salivarius + Staph sp.)	— 0/0 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.	100.0% 1/1 • Number of events 1 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.
Gastrointestinal disorders Mucositis oral	— 0/0 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.	100.0% 1/1 • Number of events 1 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.
Renal and urinary disorders Acute kidney injury (AKI)	— 0/0 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.	100.0% 1/1 • Number of events 1 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.
Cardiac disorders Myocardial infarction	— 0/0 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.	100.0% 1/1 • Number of events 1 • Assessed from start of conditioning until participant death on study at Day 35 post-transplant. Adverse events were routinely assessed via standard of care clinic visits with laboratory assessments.

Additional Information

Dr. Filippo Milano

Fred Hutchinson Cancer Center

Phone: 206.667.5925

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place