Trial Outcomes & Findings for Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin (NCT NCT00822770)

Last Updated: 2020-10-14

Results Overview

Phase I determination of MTD dose of Plerixafor in combination with a fixed dose of Filgrastim where dose limiting toxicity defined as any grade 4 non-hematologic toxicity observed within 28 days from Day 0 (day of transplant).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

47 participants

Primary outcome timeframe

28 day cycle (Plerixafor Day -7 to Day -4)

Results posted on

2020-10-14

Participant Flow

Recruitment Period: January 2, 2009 to February 1, 2012. All recruitment done at the University of Texas MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Phase I Plerixafor + G-CSF Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)	Phase II Plerixafor 240 mcg/kg + G-CSF Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.
Overall Study STARTED	18	29
Overall Study COMPLETED	15	28
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I Plerixafor + G-CSF Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)	Phase II Plerixafor 240 mcg/kg + G-CSF Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.
Overall Study Not treated	1	0
Overall Study Complication/Incomplete treatment	1	0
Overall Study Death	1	1

Baseline Characteristics

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I Plerixafor + G-CSF n=18 Participants Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)	Phase II Plerixafor 240 mcg/kg + G-CSF n=29 Participants Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.	Total n=47 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	53 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	29 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 day cycle (Plerixafor Day -7 to Day -4)

Population: Two participants of 18 registered left the study without receiving Plerixafor treatment and there were not available for MTD analysis.

Outcome measures

Outcome measures
Measure	Phase I Plerixafor + G-CSF n=16 Participants ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC) Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days. Fludarabine : Dose of 40 mg/m\^2 beginning on Day -6 for four consecutive days. ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors. Busulfan : Dose of 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine. Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.
Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor 0 mcg/kg daily	1 participants
Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor 80 mcg/kg daily	4 participants
Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor 160 mcg/kg daily	7 participants
Number of Participants With Grade 4 Dose Limiting Toxicity to Determine Maximum Tolerated Dose (MTD) Plerixafor 240 mcg/kg daily	4 participants

SECONDARY outcome

Timeframe: Baseline till transplant, Day -9 to Day 0, to 10 days

Population: Participants treated in the Phase 1 portion of the trial at the selected MTD dose were counted toward the maximum subgroup sample in Phase 2, therefore four of Phase I participants were included having received the MTD Plerixafor dose; however, one late participant in Phase 2 was not evaluable for the outcome.

In Phase II portion of study, number of participants with treatment failure defined as either disease recurrence or death, measured from start of treatment to allo transplant at Day 0.

Outcome measures

Outcome measures
Measure	Phase I Plerixafor + G-CSF n=32 Participants ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC) Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days. Fludarabine : Dose of 40 mg/m\^2 beginning on Day -6 for four consecutive days. ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors. Busulfan : Dose of 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine. Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.
Number of Participants Alive With no Disease Progression at Time of Allo Transplant Participants in	16 percentage of participants
Number of Participants Alive With no Disease Progression at Time of Allo Transplant Participants not in Complete Remission	16 percentage of participants

SECONDARY outcome

Timeframe: 30 Days post engraftment

Population: There were 39 participants receiving first transplants for acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) of both Phase I and Phase II who received MTD dose and allo transplant thus were evaluable for outcome.

Number of participants with complete chimerism at day 30 where defined as: Engraftment: first day of three (3) consecutive days that Absolute neutrophil count (ANC) exceeds 0.5 X 109/L. Subsequent chimerism studies must demonstrate the presence of donor derived cells. Graft Failure: failure to achieve an ANC \>0.5 X 109/L for 3 consecutive days within 28 days after transplantation or a decline of ANC \<0.5 x 109/L for three consecutive days after initial documented engraftment unless this is correlated with progression / recurrence of the underlying malignancy.

Outcome measures

Outcome measures
Measure	Phase I Plerixafor + G-CSF n=39 Participants ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC) Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days. Fludarabine : Dose of 40 mg/m\^2 beginning on Day -6 for four consecutive days. ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors. Busulfan : Dose of 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine. Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.
Engraftment Response Rate: Number of Transplanted Participants With Complete Chimerism at Day 30	32 Participants

Adverse Events

Phase I Plerixafor + G-CSF

Serious events: 8 serious events

Other events: 17 other events

Deaths: 0 deaths

Phase II Plerixafor 240 mcg/kg + G-CSF

Serious events: 6 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I Plerixafor + G-CSF n=18 participants at risk ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant: Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)	Phase II Plerixafor 240 mcg/kg + G-CSF n=29 participants at risk Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.
Infections and infestations Infection	16.7% 3/18 • Number of events 4 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	13.8% 4/29 • Number of events 4 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Musculoskeletal and connective tissue disorders Fall	5.6% 1/18 • Number of events 2 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	0.00% 0/29 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
General disorders Death	5.6% 1/18 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	3.4% 1/29 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Respiratory, thoracic and mediastinal disorders Pneumonia	5.6% 1/18 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	0.00% 0/29 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Skin and subcutaneous tissue disorders Graft versus Host Disease, Skin Rash	5.6% 1/18 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	6.9% 2/29 • Number of events 2 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	5.6% 1/18 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	0.00% 0/29 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Infections and infestations Neutropenic fever	5.6% 1/18 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	0.00% 0/29 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Renal and urinary disorders Hemorrhagic cyctitis	5.6% 1/18 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	0.00% 0/29 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Nervous system disorders Central Nervous System (CNS) hemorrhage	0.00% 0/18 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	3.4% 1/29 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.

Other adverse events

Additional Information

Marina Konopleva, MD, PhD / Associate Professor

The University of Texas (UT) MD Anderson Cancer Center

Phone: 713-794-1628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Phase I Plerixafor + G-CSF n=18 participants at risk ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant: Plerixafor (AMD3100) Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses + Thymoglobulin (ATG) 0.5 mg/kg on day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1. Given only to patients with unrelated donors + G-CSF (Filgrastim) 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for four consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant of Stem Cell Infusion (Bone marrow or PBPC)	Phase II Plerixafor 240 mcg/kg + G-CSF n=29 participants at risk Plerixafor Phase I Maximum Tolerated Dose (MTD) 240 mcg/kg daily for 4 days starting Day -7 + ATG 0.5 mg/kg day -3; 1.5 mg/kg on day -2; \& 2 mg/kg on day -1 only for participants with unrelated donors + G-CSF 10 mcg/kg subcutaneous injection beginning day -9 daily for 6 days + Fludarabine 40 mg/m\^2 beginning on Day -6 for four consecutive days + Busulfan 130 mg/m\^2 for 4 consecutive days, immediately after completion of Fludarabine + Allogeneic blood stem cell transplant.
Blood and lymphatic system disorders Elevated White Blood Count	44.4% 8/18 • Number of events 8 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	37.9% 11/29 • Number of events 12 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Cardiac disorders High Blood Pressure	27.8% 5/18 • Number of events 6 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	13.8% 4/29 • Number of events 4 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Cardiac disorders Change in cardiac function	5.6% 1/18 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	0.00% 0/29 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Gastrointestinal disorders Gastrointestinal disorders	50.0% 9/18 • Number of events 25 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	17.2% 5/29 • Number of events 5 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Gastrointestinal disorders Nausea	38.9% 7/18 • Number of events 9 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	51.7% 15/29 • Number of events 16 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Gastrointestinal disorders Dysphagia	44.4% 8/18 • Number of events 9 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	48.3% 14/29 • Number of events 14 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Gastrointestinal disorders Diarrhea	27.8% 5/18 • Number of events 5 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	20.7% 6/29 • Number of events 6 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
General disorders Flu-like Symptoms	66.7% 12/18 • Number of events 17 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	51.7% 15/29 • Number of events 15 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Investigations Alkaline phosphatase Increase	77.8% 14/18 • Number of events 14 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	13.8% 4/29 • Number of events 4 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Investigations Alanine aminotransferase increased	0.00% 0/18 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	6.9% 2/29 • Number of events 2 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Infections and infestations Infections	88.9% 16/18 • Number of events 36 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	37.9% 11/29 • Number of events 17 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Metabolism and nutrition disorders Metabolism and nutrition disorders: Changes within blood level	16.7% 3/18 • Number of events 3 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	0.00% 0/29 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Musculoskeletal and connective tissue disorders Bone Pain	33.3% 6/18 • Number of events 7 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	6.9% 2/29 • Number of events 2 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Nervous system disorders Nervous system disorders	44.4% 8/18 • Number of events 10 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	10.3% 3/29 • Number of events 3 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Renal and urinary disorders Urinary changes	5.6% 1/18 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	0.00% 0/29 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Renal and urinary disorders Hemoglobinuria	5.6% 1/18 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	10.3% 3/29 • Number of events 3 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Renal and urinary disorders Genitourinary disorders	27.8% 5/18 • Number of events 6 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	6.9% 2/29 • Number of events 2 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Respiratory, thoracic and mediastinal disorders Respiratory Infection, Pneumonitis	11.1% 2/18 • Number of events 2 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	3.4% 1/29 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Skin and subcutaneous tissue disorders Skin rash	50.0% 9/18 • Number of events 16 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	34.5% 10/29 • Number of events 13 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.
Injury, poisoning and procedural complications Graft versus Host Disease	22.2% 4/18 • Number of events 4 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.	3.4% 1/29 • Number of events 1 • The active treatment period defined as study entry through Stem Cell Transfusion Day +28, follow up defined as Transfusion Day +29 through Day +100.