Trial Outcomes & Findings for AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders (NCT NCT00547196)

NCT ID: NCT00547196

Last Updated: 2024-06-14

Results Overview

Number of surviving patients at Day 100 post-transplant divided by number of patients undergone transplantation.

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

From transplant to Day 100 post-transplant

Results posted on

2024-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Regimen I (FTBI, Cyclophosphamide, Fludarabine) Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclophosphamide Cyclosporine Fludarabine phosphate Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation Fractionated total body irradiation	Regimen III (TBI, Cyclophosphamide, Fludarabine) Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclophosphamide Cyclosporine Fludarabine phosphate Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation total-body irradiation	Regimen IV (Fludarabine, Melphalan) Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclosporine Fludarabine phosphate Melphalan Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation	Unassigned Patients consented but were not eligible for the treatment after screening.
Overall Study STARTED	5	1	2	2
Overall Study COMPLETED	5	1	2	2
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Regimen I (FTBI, Cyclophosphamide, Fludarabine) n=5 Participants Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclophosphamide Cyclosporine Fludarabine phosphate Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation Fractionated total body irradiation	Regimen II (Busulfan, Fludarabine, Melphalan) Patients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Busulfan Cyclosporine Fludarabine phosphate Melphalan Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation	Regimen III (TBI, Cyclophosphamide, Fludarabine) n=1 Participants Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclophosphamide Cyclosporine Fludarabine phosphate Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation total-body irradiation	Regimen IV (Fludarabine, Melphalan) n=2 Participants Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclosporine Fludarabine phosphate Melphalan Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation	Unassigned n=2 Participants Patients consented but were not eligible for the treatment after screening.	Total n=10 Participants Total of all reporting groups
Age, Continuous	14 years n=5 Participants	—	58 years n=5 Participants	35 years n=4 Participants	18.5 years n=21 Participants	15 years n=8 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	—	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	7 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	—	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	—	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Region of Enrollment United States	5 participants n=5 Participants	—	1 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants	10 participants n=8 Participants

PRIMARY outcome

Timeframe: From transplant to Day 100 post-transplant

Population: No subject in the Regimen II arm.

Number of surviving patients at Day 100 post-transplant divided by number of patients undergone transplantation.

Outcome measures

Outcome measures
Measure	Regimen I (FTBI, Cyclophosphamide, Fludarabine) n=5 Participants Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclophosphamide Cyclosporine Fludarabine phosphate Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation Fractionated total body irradiation	Regimen II (Busulfan, Fludarabine, Melphalan) Patients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Busulfan Cyclosporine Fludarabine phosphate Melphalan Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation	Regimen III (TBI, Cyclophosphamide, Fludarabine) n=1 Participants Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclophosphamide Cyclosporine Fludarabine phosphate Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation total-body irradiation	Regimen IV (Fludarabine, Melphalan) n=2 Participants Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclosporine Fludarabine phosphate Melphalan Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation
Survival Rate at Day 100 After Allogeneic Transplant From Umbilical Cord Blood (UCB)	100 percentage of surviving patients	—	100 percentage of surviving patients	100 percentage of surviving patients

SECONDARY outcome

Timeframe: From transplant up to Day 180 post-transplant

Population: No subject in the Regimen II arm.

Number of surviving patients at Day 180 post-transplant divided by number of patients undergone transplantation.

Outcome measures

Outcome measures
Measure	Regimen I (FTBI, Cyclophosphamide, Fludarabine) n=5 Participants Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclophosphamide Cyclosporine Fludarabine phosphate Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation Fractionated total body irradiation	Regimen II (Busulfan, Fludarabine, Melphalan) Patients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Busulfan Cyclosporine Fludarabine phosphate Melphalan Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation	Regimen III (TBI, Cyclophosphamide, Fludarabine) n=1 Participants Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclophosphamide Cyclosporine Fludarabine phosphate Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation total-body irradiation	Regimen IV (Fludarabine, Melphalan) n=2 Participants Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclosporine Fludarabine phosphate Melphalan Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation
Survival Rate at Day 180 After Allogeneic Transplant From Umbilical Cord Blood (UCB)	60 percentage of surviving patients	—	100 percentage of surviving patients	50 percentage of surviving patients

Adverse Events

Regimen I (FTBI, Cyclophosphamide, Fludarabine)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 3 deaths

Regimen II (Busulfan, Fludarabine, Melphalan)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Regimen III (TBI, Cyclophosphamide, Fludarabine)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Regimen IV (Fludarabine, Melphalan)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Regimen I (FTBI, Cyclophosphamide, Fludarabine) n=5 participants at risk Patients undergo FTBI 2-3 times a day on days -9 to -6 for a total of 11 fractions. Patients also receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclophosphamide Cyclosporine Fludarabine phosphate Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation Fractionated total body irradiation	Regimen II (Busulfan, Fludarabine, Melphalan) Patients receive a test dose of busulfan on day -10 and then dose adjusted busulfan IV 3-4 times daily on days -9 to -6, melphalan IV on days -5 and -4, and fludarabine phosphate IV on days -5 to -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Busulfan Cyclosporine Fludarabine phosphate Melphalan Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation	Regimen III (TBI, Cyclophosphamide, Fludarabine) n=1 participants at risk Patients receive fludarabine phosphate IV on days -8 to -4 and cyclophosphamide IV over 2 hours on day -3 and undergo TBI (single dose) on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclophosphamide Cyclosporine Fludarabine phosphate Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation total-body irradiation	Regimen IV (Fludarabine, Melphalan) n=2 participants at risk Patients receive fludarabine phosphate IV on days -7 to -3 and melphalan IV on day -2. UCB transplantation: Patients receive 2 combined units of UCB IV on day 0. Patients also receive G-CSF IV or subcutaneously beginning on day 5 (or later) and continuing until blood counts recover. GVHD prophylaxis: Patients receive cyclosporine IV twice daily beginning on day -1 followed by a taper according to institutional guidelines. Patients also receive mycophenolate mofetil orally or IV beginning on day 0 and continuing until day 27 (or as clinically indicated). filgrastim Cyclosporine Fludarabine phosphate Melphalan Mycophenolate Mofetil allogeneic hematopoietic stem cell transplantation umbilical cord blood transplantation
Blood and lymphatic system disorders Hemorrhage, GU	0.00% 0/5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	— 0/0 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	0.00% 0/1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	50.0% 1/2 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.
Infections and infestations Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)	20.0% 1/5 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	— 0/0 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	100.0% 1/1 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	0.00% 0/2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.
Infections and infestations Infection, Bacterial (COH)	0.00% 0/5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	— 0/0 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	100.0% 1/1 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	0.00% 0/2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	20.0% 1/5 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	— 0/0 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	0.00% 0/1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	0.00% 0/2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	20.0% 1/5 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	— 0/0 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	0.00% 0/1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	0.00% 0/2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.
Investigations Creatinine	0.00% 0/5 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	— 0/0 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	0.00% 0/1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	50.0% 1/2 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	20.0% 1/5 • Number of events 1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	— 0/0 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	0.00% 0/1 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.	0.00% 0/2 • Adverse Events monitored/assessed up to 100 days post-transplant. All-Cause Mortality monitored/assessed up to 9 years post-transplant. No subject in the Regimen II arm.

Other adverse events

Additional Information

Dr. Anna Pawlowska, MD

City of Hope

Phone: 626-359-8111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place