Trial Outcomes & Findings for Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies (NCT NCT00040846)

NCT ID: NCT00040846

Last Updated: 2020-01-29

Results Overview

Percentage patients with Day 100 transplant related mortality.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: 100 days after transplant
• Results posted on: 2020-01-29

Participant Flow

Participant milestones

Measure	Dose Level 1 (No Campath) CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO	Dose Level 2 (0.025 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 3 (0.050 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 4 (0.10 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 5 (0.20 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 6 (0.40 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
Overall Study STARTED	60	0	0	0	0	0
Overall Study COMPLETED	60	0	0	0	0	0
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

Baseline characteristics by cohort

Measure	Dose Level 1 (No Campath) n=60 Participants CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO	Dose Level 2 (0.025 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 3 (0.050 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 4 (0.10 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 5 (0.20 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 6 (0.40 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	—	—	—	—	—	1 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=5 Participants	—	—	—	—	—	52 Participants n=8 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	—	—	—	—	—	7 Participants n=8 Participants
Age, Continuous	56.7 years n=5 Participants	—	—	—	—	—	56.7 years n=8 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	—	—	—	—	—	15 Participants n=8 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	—	—	—	—	—	45 Participants n=8 Participants
Region of Enrollment United States	60 participants n=5 Participants	—	—	—	—	—	60 participants n=8 Participants

PRIMARY outcome

Timeframe: 100 days after transplant

Population: No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Percentage patients with Day 100 transplant related mortality.

Outcome measures

Measure	Dose Level 1 (No Campath) n=60 Participants CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO	Dose Level 2 (0.025 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 3 (0.050 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 4 (0.10 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 5 (0.20 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 6 (0.40 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
Evaluate the Risk of Transplant Related Mortality.	20 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 1 year after transplant

Population: No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Percentage patients who developed acute/chronic GVHD.

aGVHD Stages

Skin:

1. a maculopapular eruption involving < 25% BSA

2. a maculopapular eruption involving 25 - 50% BSA

3. generalized erythroderma

4. generalized erythroderma with bullous formation and often with desquamation

Liver:

1. bilirubin 2.0 - 3.0 mg/100 mL

2. bilirubin 3 - 5.9 mg/100 mL

3. bilirubin 6 - 14.9 mg/100 mL

4. bilirubin > 15 mg/100 mL

Gut:

Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall.

aGVHD Grades Grade III: Stage 2 - 4 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Outcome measures

Measure	Dose Level 1 (No Campath) n=60 Participants CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO	Dose Level 2 (0.025 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 3 (0.050 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 4 (0.10 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 5 (0.20 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 6 (0.40 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
Evaluate the Risk of Occurrence of Acute and Chronic GVHD Grade III-IV aGVHD	23.3 percentage of participants	—	—	—	—	—
Evaluate the Risk of Occurrence of Acute and Chronic GVHD cGVHD	41.7 percentage of participants	—	—	—	—	—

PRIMARY outcome

Timeframe: 100 days after transplant

Population: No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as > 95% donor CD3+ T cells.

Outcome measures

Measure	Dose Level 1 (No Campath) n=60 Participants CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO	Dose Level 2 (0.025 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 3 (0.050 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 4 (0.10 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 5 (0.20 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 6 (0.40 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. CD3 - Graft rejection	3.3 percentage of participants	—	—	—	—	—
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. CD3 - Mixed chimerism	18.3 percentage of participants	—	—	—	—	—
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. CD3 - Full donor chimerism	70 percentage of participants	—	—	—	—	—
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. CD3 - Unknown	8.33 percentage of participants	—	—	—	—	—
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. CD33 - Graft Rejection	1.7 percentage of participants	—	—	—	—	—
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. CD33 - Mixed chimerism	3.3 percentage of participants	—	—	—	—	—
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. CD33 - Full donor chimerism	80 percentage of participants	—	—	—	—	—
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%. CD33 - Unknown	15 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 100 days after transplant

Population: No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Percentage patients who experienced infections within 100 days post-transplant.

Outcome measures

Measure	Dose Level 1 (No Campath) n=60 Participants CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO	Dose Level 2 (0.025 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 3 (0.050 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 4 (0.10 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 5 (0.20 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 6 (0.40 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
Evaluate the Risk/Incidence of Infections	91.7 percentage of participants	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 year after transplant

Population: No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Percentage patients who relapsed/progressed within 1 year post-transplant.

Outcome measures

Measure	Dose Level 1 (No Campath) n=60 Participants CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO	Dose Level 2 (0.025 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 3 (0.050 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 4 (0.10 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 5 (0.20 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 6 (0.40 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
Evaluate the Risk for Disease Progression and Relapse	21.7 percentage of participants	—	—	—	—	—

Adverse Events

Dose Level 1 (No Campath)

Serious events: 24 serious events

Other events: 33 other events

Deaths: 0 deaths

Dose Level 2 (0.025 mg/kg/Day Campath)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dose Level 3 (0.050 mg/kg/Day Campath)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dose Level 4 (0.10 mg/kg/Day Campath)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dose Level 5 (0.20 mg/kg/Day Campath)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dose Level 6 (0.40 mg/kg/Day Campath)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dose Level 1 (No Campath) n=60 participants at risk CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO	Dose Level 2 (0.025 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 3 (0.050 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 4 (0.10 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 5 (0.20 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 6 (0.40 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
Cardiac disorders Cardiac troponin I increased	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Cardiac disorders Heart failure	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Gastrointestinal disorders Gastric perforation	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
General disorders Multi-organ failure	6.7% 4/60 • Number of events 4 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Immune system disorders GVHD	13.3% 8/60 • Number of events 8 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Infections and infestations Sepsis	8.3% 5/60 • Number of events 5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary Malignancy	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Nervous system disorders Leukoencephalopathy	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Respiratory, thoracic and mediastinal disorders Pleural hemorrhage	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.0% 3/60 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Vascular disorders Thromboembolic event	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Other adverse events

Measure	Dose Level 1 (No Campath) n=60 participants at risk CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO	Dose Level 2 (0.025 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 3 (0.050 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 4 (0.10 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 5 (0.20 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV	Dose Level 6 (0.40 mg/kg/Day Campath) CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
Gastrointestinal disorders Abdominal pain	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Renal and urinary disorders Acute kidney injury	3.3% 2/60 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Immune system disorders Anaphylaxis	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Metabolism and nutrition disorders Anorexia	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Investigations Aspartate aminotransferase increased	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Nervous system disorders Ataxia	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Cardiac disorders Atrial fibrillation	3.3% 2/60 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other (Coagulopathy)	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Investigations Blood bilirubin increased	21.7% 13/60 • Number of events 13 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Vascular disorders Capillary leak syndrome	3.3% 2/60 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Investigations Creatinine increased	8.3% 5/60 • Number of events 5 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Metabolism and nutrition disorders Dehydration	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Gastrointestinal disorders Diarrhea	3.3% 2/60 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Blood and lymphatic system disorders Febrile neutropenia	3.3% 2/60 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Gastrointestinal disorders Gastric hemorrhage	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Blood and lymphatic system disorders Hemolysis	3.3% 2/60 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Metabolism and nutrition disorders Hyperglycemia	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Metabolism and nutrition disorders Hyperkalemia	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Vascular disorders Hypertension	5.0% 3/60 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Metabolism and nutrition disorders Hypokalemia	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Metabolism and nutrition disorders Hyponatremia	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Vascular disorders Hypotension	6.7% 4/60 • Number of events 4 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	16.7% 10/60 • Number of events 12 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Infections and infestations Infections and infestations - Other (Blood)	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Nervous system disorders Leukoencephalopathy	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Infections and infestations Lung infection	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Cardiac disorders Myocardial infaction	5.0% 3/60 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Investigations Neutrophil count decreased	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.3% 2/60 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Infections and infestations Sepsis	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Injury, poisoning and procedural complications Spinal injury	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Vascular disorders Thromboembolic event	5.0% 3/60 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Metabolism and nutrition disorders Tumor lysis syndrome	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Cardiac disorders Ventricular arrhythmia	5.0% 3/60 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Blood and lymphatic system disorders Anemia	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Cardiac disorders Heart Failure	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Blood and lymphatic system disorders Blood and lymphatic System Disorder - Other (Hemoptysis)	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
Renal and urinary disorders Renal and urinary disorders - Other (BUN increased)	1.7% 1/60 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200 No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Additional Information

Dr. Brenda M. Sandmaier

Fred Hutchinson Cancer Research Center

Phone: (206) 667-4961

Email: bsandmai@fhcrc.org

Results disclosure agreements

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