Trial Outcomes & Findings for Safety Study of Bone Marrow Transplant Using Mismatched Tissue Followed by Chemotherapy (NCT NCT00796562)

NCT ID: NCT00796562

Last Updated: 2019-03-14

Results Overview

Percentage of participants who achieved donor chimerism \>=95%.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 107 participants
• Primary outcome timeframe: Day 60
• Results posted on: 2019-03-14

Participant Flow

11 participants were screen failures.

Participant milestones

Measure	Myeloablative Haploidentical BMT * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.
Overall Study STARTED	96
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	49

Reasons for withdrawal

Measure

Myeloablative Haploidentical BMT * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.

Overall Study Death

49

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Myeloablative Haploidentical BMT n=96 Participants * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.
Age, Categorical <=18 years	15 Participants n=96 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=96 Participants
Age, Categorical >=65 years	1 Participants n=96 Participants
Age, Continuous	42 years n=96 Participants
Sex: Female, Male Female	40 Participants n=96 Participants
Sex: Female, Male Male	56 Participants n=96 Participants
Region of Enrollment United States	96 Participants n=96 Participants

PRIMARY outcome

Timeframe: Day 60

Population: 8 participants were not evaluable for this outcome because they died prior to Day 60.

Percentage of participants who achieved donor chimerism >=95%.

Outcome measures

Measure

Myeloablative Haploidentical BMT n=88 Participants * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.

Engraftment as Measured by Donor Chimerism

91 percentage of participants Interval 83.0 to 96.0

SECONDARY outcome

Timeframe: Day 100, 1 year

Number of participants deceased for reasons other than disease relapse or progression.

Outcome measures

Measure	Myeloablative Haploidentical BMT n=96 Participants * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.
Non-relapse Mortality 100 days	10 Participants
Non-relapse Mortality 1 year	10 Participants

SECONDARY outcome

Timeframe: Day 100

Percentage of participants who experience grade II-IV or III-IV acute graft-versus-host-disease (GVHD) by Przepiorka criteria. The stages are defined as follows:

• Stage II: Rash on >50% of skin, bilirubin 2-3 mg/dL, or diarrhea 500-1000 mL/day
• Stage III: Bilirubin 3-15 mg/dL or diarrhea >1000 mL/day
• Stage IV: Generalized erythroderma with bullae or bilirubin >15 mg/dL This outcome was estimated using proportional subdistribution hazard regression model for competing risks (Fine and Gray 1999)

Outcome measures

Measure	Myeloablative Haploidentical BMT n=96 Participants * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.
Acute GVHD Grade II-IV	11 percentage of participants Interval 5.0 to 18.0
Acute GVHD Grade III-IV	4 percentage of participants Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 6 months, 12 months

Percentage of participants who experience chronic GVHD. Chronic GVHD is graded using NIH consensus criteria and Seattle criteria. This outcome was estimated using proportional subdistribution hazard regression model for competing risks (Fine and Gray 1999)

Outcome measures

Measure	Myeloablative Haploidentical BMT n=96 Participants * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.
Chronic GVHD 6 months	4 percentage of participants Interval 0.0 to 8.0
Chronic GVHD 12 months	15 percentage of participants Interval 8.0 to 22.0

SECONDARY outcome

Timeframe: 1 year, 2 years, 3 years

Percentage of participants alive (overall survival) and alive without disease relapse, progression, or diagnosis of myeloid malignancy (event-free survival). Estimated using Kaplan-Meier method.

Outcome measures

Measure	Myeloablative Haploidentical BMT n=96 Participants * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.
Survival Overall survival, 1 year	73 percentage of participants Interval 65.0 to 82.0
Survival Overall survival, 2 years	57 percentage of participants Interval 48.0 to 68.0
Survival Overall survival, 3 years	54 percentage of participants Interval 44.0 to 65.0
Survival Event-free survival, 1 year	58 percentage of participants Interval 48.0 to 69.0
Survival Event-free survival, 2 years	52 percentage of participants Interval 42.0 to 63.0
Survival Event-free survival, 3 years	50 percentage of participants Interval 41.0 to 62.0

SECONDARY outcome

Timeframe: 1 year, 3 years

Population: The entire set of participants was analyzed as one group, and the analysis was planned this way from the beginning of the study.

Percentage of participants who experienced disease progression or relapse. This outcome was estimated using proportional subdistribution hazard regression model for competing risks (Fine and Gray 1999)

Outcome measures

Measure	Myeloablative Haploidentical BMT n=96 Participants * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.
Relapse 1 year	35 percentage of participants Interval 26.0 to 45.0
Relapse 3 years	43 percentage of participants Interval 33.0 to 553.0

Adverse Events

Myeloablative Haploidentical BMT

Serious events: 22 serious events

Other events: 37 other events

Deaths: 49 deaths

Serious adverse events

Measure	Myeloablative Haploidentical BMT n=96 participants at risk * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.
Nervous system disorders Altered mental status	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Aspergillosis	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations BK virus	2.1% 2/96 • Number of events 2 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
General disorders Bleeding	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Cardiac disorders Cardiac arrest	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Cardiac disorders Cardiomegaly	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Cardiac disorders Cardiomyopathy	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Cytomegalovirus	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Coagulase-negative staphylococcus	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Coronavirus NL63	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Blood and lymphatic system disorders Deep vein thrombosis	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Multi-drug resistant Klebsiella bacteremia	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Musculoskeletal and connective tissue disorders Fracture	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Fungal pneumonia	3.1% 3/96 • Number of events 3 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Fungal sinusitis	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Investigations Graft failure	2.1% 2/96 • Number of events 2 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Human herpesvirus 6	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Human metapneumovirus	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Cardiac disorders Hypotension	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Nervous system disorders Intracranial hemorrhage	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Hepatobiliary disorders Liver failure	2.1% 2/96 • Number of events 2 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Immune system disorders Liver graft-versus-host-disease	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Metabolism and nutrition disorders Metabolic acidosis	2.1% 2/96 • Number of events 2 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Immune system disorders Hemolytic anemia	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Immune system disorders Multisystem organ dysfunction syndrome	3.1% 3/96 • Number of events 3 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Febrile neutropenia	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Cardiac disorders Pericardial effusion	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.1% 2/96 • Number of events 2 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Pneumonia	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Nervous system disorders Posterior reversible encephalopathy syndrome	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Renal and urinary disorders Renal failure	9.4% 9/96 • Number of events 10 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Metabolism and nutrition disorders Respiratory and metabolic acidosis	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.2% 6/96 • Number of events 6 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Rhinovirus	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Sepsis	3.1% 3/96 • Number of events 3 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Cardiac disorders Sinus tachycardia	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Nervous system disorders Subarachnoid hemorrhage	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Cardiac disorders Superior vena cava syndrome	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Hepatobiliary disorders Veno-occlusive disease	3.1% 3/96 • Number of events 5 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Vancomycin-resistant Enterococcus	1.0% 1/96 • Number of events 1 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.

Other adverse events

Measure	Myeloablative Haploidentical BMT n=96 participants at risk * All participants except those with acute lymphoblastic leukemia and lymphoblastic lymphoma: Busulfan will be administered 1 mg/kg oral (or 0.8 mg/kg IV) four times per day for four days, followed by cyclophosphamide 50 mg/kg once per day for two days. * Participants with acute lymphocytic leukemia or lymphoblastic lymphoma: Cyclophosphamide will be administered 50 mg/kg once per day for two days, followed by total body irradiation at 300 cGy per day for four days.
Renal and urinary disorders Acute kidney injury	8.3% 8/96 • Number of events 8 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations BK virus	6.2% 6/96 • Number of events 6 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Clostridium difficile	13.5% 13/96 • Number of events 13 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Cytomegalovirus	14.6% 14/96 • Number of events 19 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Infections and infestations Febrile neutropenia	7.3% 7/96 • Number of events 7 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.
Skin and subcutaneous tissue disorders Mucositis	10.4% 10/96 • Number of events 10 • Up to 2 years Only the following adverse events were collected per protocol: non-relapse mortality in the first 100 days after BMT; graft failure; and all unexpected events considered significant by the principal investigator. Adverse events were assessed weekly through Day 60 and at Days 180, 365, and 730.

Additional Information

Heather Symons, MD

Johns Hopkins University

Phone: 4105029961

Email: hsymons2@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place