Trial Outcomes & Findings for Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (NCT NCT00469014)

NCT ID: NCT00469014

Last Updated: 2021-01-26

Results Overview

Number of participants with treatment related mortality (death) within the first 30 days following transplantation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

First 30 Days

Results posted on

2021-01-26

Participant Flow

Recruitment Details: September 25, 2006 to March 30, 2011. All participants were recruited at the University of Texas (UT) MD Anderson Cancer Center.

Of the 72 enrolled participants, one participant was not eligible and not treated. In the initial phase, the first 20 participants were fairly randomized to each of the 4 treatment arms. The rest of the participants were adaptively randomized among the arms in period 2.

Participant milestones

Participant milestones
Measure	Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine 4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m\^2 intravenous (IV) Daily + Fludarabine 30 mg/m\^2 IV Daily; + Clofarabine 10 mg/m\^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine 4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m\^2 IV + Fludarabine 20 mg/m\^2 IV Daily + Clofarabine 20 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine 4-day Treatment Period Day -6 to Day -2: Busulfan 10 mg/m\^2 IV Daily + Fludarabine 10 mg/m\^2 IV Daily + Clofarabine 30 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 4: Busulfan + Clofarabine 4-day Treatment Period Day -6 to Day -2: Busulfan 40 mg/m\^2 IV Daily + Clofarabine 40 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
Initial Phase Randomization STARTED	5	4	5	6
Initial Phase Randomization COMPLETED	4	3	4	5
Initial Phase Randomization NOT COMPLETED	1	1	1	1
Adaptive Randomization STARTED	13	3	24	11
Adaptive Randomization COMPLETED	12	2	23	10
Adaptive Randomization NOT COMPLETED	1	1	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine 4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m\^2 intravenous (IV) Daily + Fludarabine 30 mg/m\^2 IV Daily; + Clofarabine 10 mg/m\^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine 4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m\^2 IV + Fludarabine 20 mg/m\^2 IV Daily + Clofarabine 20 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine 4-day Treatment Period Day -6 to Day -2: Busulfan 10 mg/m\^2 IV Daily + Fludarabine 10 mg/m\^2 IV Daily + Clofarabine 30 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 4: Busulfan + Clofarabine 4-day Treatment Period Day -6 to Day -2: Busulfan 40 mg/m\^2 IV Daily + Clofarabine 40 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
Initial Phase Randomization Disease Progression	0	1	1	0
Initial Phase Randomization No Response	1	0	0	1
Adaptive Randomization Not Evaluable	1	0	0	1
Adaptive Randomization No Response	0	1	0	0
Adaptive Randomization Death	0	0	1	0

Baseline Characteristics

Busulfan, Fludarabine, Clofarabine With Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine n=18 Participants 4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m\^2 intravenous (IV) Daily + Fludarabine 30 mg/m\^2 IV Daily; + Clofarabine 10 mg/m\^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine n=7 Participants 4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m\^2 IV + Fludarabine 20 mg/m\^2 IV Daily + Clofarabine 20 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine n=29 Participants 4-day Treatment Period Day -6 to Day -2: Busulfan 10 mg/m\^2 IV Daily + Fludarabine 10 mg/m\^2 IV Daily + Clofarabine 30 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 4: Busulfan + Clofarabine n=17 Participants 4-day Treatment Period Day -6 to Day -2: Busulfan 40 mg/m\^2 IV Daily + Clofarabine 40 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Total n=71 Participants Total of all reporting groups
Age, Continuous	33 years n=39 Participants	54 years n=41 Participants	38 years n=35 Participants	47 years n=31 Participants	46 years n=146 Participants
Sex: Female, Male Female	10 Participants n=39 Participants	1 Participants n=41 Participants	14 Participants n=35 Participants	6 Participants n=31 Participants	31 Participants n=146 Participants
Sex: Female, Male Male	8 Participants n=39 Participants	6 Participants n=41 Participants	15 Participants n=35 Participants	11 Participants n=31 Participants	40 Participants n=146 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=39 Participants	1 Participants n=41 Participants	4 Participants n=35 Participants	3 Participants n=31 Participants	15 Participants n=146 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=39 Participants	6 Participants n=41 Participants	24 Participants n=35 Participants	14 Participants n=31 Participants	54 Participants n=146 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants	0 Participants n=31 Participants	2 Participants n=146 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants
Race (NIH/OMB) Asian	1 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	1 Participants n=146 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants
Race (NIH/OMB) Black or African American	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants	0 Participants n=31 Participants	4 Participants n=146 Participants
Race (NIH/OMB) White	15 Participants n=39 Participants	6 Participants n=41 Participants	26 Participants n=35 Participants	17 Participants n=31 Participants	64 Participants n=146 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=31 Participants	0 Participants n=146 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants	0 Participants n=31 Participants	2 Participants n=146 Participants
Region of Enrollment United States	18 participants n=39 Participants	7 participants n=41 Participants	29 participants n=35 Participants	17 participants n=31 Participants	71 participants n=146 Participants

PRIMARY outcome

Timeframe: First 30 Days

Number of participants with treatment related mortality (death) within the first 30 days following transplantation.

Outcome measures

Outcome measures
Measure	Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine n=13 Participants 4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m\^2 intravenous (IV) Daily + Fludarabine 30 mg/m\^2 IV Daily; + Clofarabine 10 mg/m\^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine n=3 Participants 4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m\^2 IV + Fludarabine 20 mg/m\^2 IV Daily + Clofarabine 20 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine n=24 Participants 4-day Treatment Period Day -6 to Day -2: Busulfan 10 mg/m\^2 IV Daily + Fludarabine 10 mg/m\^2 IV Daily + Clofarabine 30 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 4: Busulfan + Clofarabine n=11 Participants 4-day Treatment Period Day -6 to Day -2: Busulfan 40 mg/m\^2 IV Daily + Clofarabine 40 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
Treatment Related Mortality	0 participants	0 participants	0 participants	0 participants

Adverse Events

Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine

Serious events: 15 serious events

Other events: 18 other events

Deaths: 2 deaths

Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine

Serious events: 6 serious events

Other events: 7 other events

Deaths: 1 deaths

Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine

Serious events: 27 serious events

Other events: 29 other events

Deaths: 4 deaths

Arm 4: Busulfan + Clofarabine

Serious events: 15 serious events

Other events: 16 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Richard Champlin, MD / Professor, Chair, Stem Cell Transplantation

University of Texas MD Anderson Cancer Center

Phone: 713-792-3618

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine n=72 participants at risk；n=71 participants at risk 4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m\^2 intravenous (IV) Daily + Fludarabine 30 mg/m\^2 IV Daily; + Clofarabine 10 mg/m\^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine n=72 participants at risk；n=71 participants at risk 4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m\^2 IV + Fludarabine 20 mg/m\^2 IV Daily + Clofarabine 20 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine n=72 participants at risk；n=71 participants at risk 4-day Treatment Period Day -6 to Day -2: Busulfan 10 mg/m\^2 IV Daily + Fludarabine 10 mg/m\^2 IV Daily + Clofarabine 30 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 4: Busulfan + Clofarabine n=72 participants at risk；n=71 participants at risk 4-day Treatment Period Day -6 to Day -2: Busulfan 40 mg/m\^2 IV Daily + Clofarabine 40 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
Gastrointestinal disorders Abdominal pain	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
General disorders AL OTH	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Investigations ALK increased	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Immune system disorders Allergic reaction	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Investigations ALT increased	9.9% 7/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	8.5% 6/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	7.0% 5/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Metabolism and nutrition disorders Anorexia	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Psychiatric disorders Anxiety	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Investigations AST increased	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Infections and infestations Bacterial	5.6% 4/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	18.3% 13/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	8.5% 6/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Blood and lymphatic system disorders Bleeding (no GI no PUL)	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Eye disorders Blurred vision	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Respiratory, thoracic and mediastinal disorders BOOP	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Respiratory, thoracic and mediastinal disorders Broncholitis obliterans	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Cardiac disorders Chest pain	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Skin and subcutaneous tissue disorders Chronic GVHD	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Psychiatric disorders Confusion	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Investigations Creatinine increased	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Respiratory, thoracic and mediastinal disorders DAH	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Gastrointestinal disorders Diarrhea	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Nervous system disorders Dizziness	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Eye disorders Dry eye	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Cardiac disorders Dysrhythmia	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Cardiac disorders Ejection fraction decreased	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Nervous system disorders Encephalopathy	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
General disorders Fatigue	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Blood and lymphatic system disorders Febrile neutropenia	11.3% 8/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	21.1% 15/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	11.3% 8/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
General disorders Fever	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
General disorders Fluid overload	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Infections and infestations Fungal	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Gastrointestinal disorders Gastrointestinal bleeding	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Gastrointestinal disorders GI FIS	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Gastrointestinal disorders GI OTH	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Psychiatric disorders Hallucination	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Nervous system disorders Headache	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.

Other adverse events
Measure	Arm 1: Busulfan + Fludarabine (30 mg/m^2) + Clofarabine n=72 participants at risk；n=71 participants at risk 4-day Treatment Period Day -6 to Day -2: Busulfan 30 mg/m\^2 intravenous (IV) Daily + Fludarabine 30 mg/m\^2 IV Daily; + Clofarabine 10 mg/m\^2 IV Daily; Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 2: Busulfan + Fludarabine (20 mg/m^2) + Clofarabine n=72 participants at risk；n=71 participants at risk 4-day Treatment Period Day -6 to Day -2: Busulfan 20 mg/m\^2 IV + Fludarabine 20 mg/m\^2 IV Daily + Clofarabine 20 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 3: Busulfan + Fludarabine (10 mg/m^2) + Clofarabine n=72 participants at risk；n=71 participants at risk 4-day Treatment Period Day -6 to Day -2: Busulfan 10 mg/m\^2 IV Daily + Fludarabine 10 mg/m\^2 IV Daily + Clofarabine 30 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.	Arm 4: Busulfan + Clofarabine n=72 participants at risk；n=71 participants at risk 4-day Treatment Period Day -6 to Day -2: Busulfan 40 mg/m\^2 IV Daily + Clofarabine 40 mg/m\^2 IV Daily. Thymoglobulin Day -3 to Day -1, and Stem Cell Infusion Day 0.
Gastrointestinal disorders Abdominal pain	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
General disorders AL OTH	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Investigations ALK increased	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	7.0% 5/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Immune system disorders Allergic reaction	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Investigations ALT increased	14.1% 10/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	14.1% 10/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	7.0% 5/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Metabolism and nutrition disorders Anorexia	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Psychiatric disorders Anxiety	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Investigations AST increased	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Infections and infestations Bacterial	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	7.0% 5/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Blood and lymphatic system disorders Bleeding (no GI no PUL)	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Eye disorders Blurred vision	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Musculoskeletal and connective tissue disorders Bone pain	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Respiratory, thoracic and mediastinal disorders BOOP	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Respiratory, thoracic and mediastinal disorders Broncholitis obliterans	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Cardiac disorders Chest pain	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Skin and subcutaneous tissue disorders Chronic GVHD	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Psychiatric disorders Confusion	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Investigations Creatinine increased	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	5.6% 4/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Respiratory, thoracic and mediastinal disorders DAH	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Gastrointestinal disorders Diarrhea	11.3% 8/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	7.0% 5/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	9.9% 7/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Nervous system disorders Dizziness	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Eye disorders Dry eye	5.6% 4/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	9.9% 7/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Cardiac disorders Dysrhythmia	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Cardiac disorders Ejection fraction decreased	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Nervous system disorders Encephalopathy	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
General disorders Fatigue	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Blood and lymphatic system disorders Febrile neutropenia	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
General disorders Fever	9.9% 7/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	16.9% 12/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	9.9% 7/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
General disorders Fluid overload	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Infections and infestations Fungal	4.2% 3/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	5.6% 4/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Gastrointestinal disorders Gastrointestinal bleeding	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Gastrointestinal disorders GI FIS	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Gastrointestinal disorders GI OTH	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Psychiatric disorders Hallucination	1.4% 1/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	0.00% 0/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.
Nervous system disorders Headache	8.5% 6/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	2.8% 2/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	9.9% 7/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.	7.0% 5/71 • Enrollment period defined as BMT Day -9 through BMT Day +28, post study surveillance defined as BMT Day +29 through +100. Thereafter, participant status/survival data collected quarterly as available. End of active treatment is day of stem cell infusion.