Trial Outcomes & Findings for Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer (NCT NCT00118352)

NCT ID: NCT00118352

Last Updated: 2017-05-30

Results Overview

Severity of Individual Organ Involvement Liver: Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin \> 15mg/100ml Gut: Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 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 Severity of GVHD Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: 100 days after transplant
• Results posted on: 2017-05-30

Participant Flow

Participant milestones

Measure	Dose Level 1 (No Campath) Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation NOTE: No subjects were enrolled at this dose level as the escalation rule was not met.	Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation NOTE: No subjects were enrolled at this dose level as the escalation rule was not met.
Overall Study STARTED	12	0	0
Overall Study COMPLETED	12	0	0
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

Baseline characteristics by cohort

Measure	Dose Level 1 (No Campath) n=12 Participants Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Age, Continuous	58.6 years n=5 Participants	—	—	58.6 years n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	—	—	6 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	—	—	6 Participants n=4 Participants
Region of Enrollment United States	12 participants n=5 Participants	—	—	12 participants n=4 Participants

PRIMARY outcome

Timeframe: 100 days after transplant

Severity of Individual Organ Involvement

Liver:

Stage 2 - bilirubin (3-5.9mg/100ml) Stage 3 - bilirubin (6-14.9mg/100ml) Stage 4 - bilirubin > 15mg/100ml

Gut:

Diarrhea is graded stage 1 to stage 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as stage 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

Severity of GVHD

Grade III - Stage 2 to 4 gastrointestinal involvement and/or Stage 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=12 Participants Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
Incidence of Grade III-IV Acute GVHD	25 percentage of participants	—	—

SECONDARY outcome

Timeframe: 84 days after transplant

Percentage patients that experienced graft rejection.

Outcome measures

Measure	Dose Level 1 (No Campath) n=12 Participants Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
Incidence of Graft Rejection	0 percentage of participants	—	—

SECONDARY outcome

Timeframe: 100 days after transplant

Percentage patients requiring steroids greater than 1 mg/kg.

Outcome measures

Measure	Dose Level 1 (No Campath) n=12 Participants Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
Incidence of High-dose Corticosteroid Utilization.	83.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: 100 days after transplant

Percentage patient deaths due to non-relapse mortality

Outcome measures

Measure	Dose Level 1 (No Campath) n=12 Participants Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
Incidence of Non-relapse Mortality	8.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Up to 5 years post-transplant

Percentage patients that experienced infection(s).

Outcome measures

Measure	Dose Level 1 (No Campath) n=12 Participants Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
Incidence of Infection	100 percentage of participants	—	—

SECONDARY outcome

Timeframe: Up to 1 year post-transplant

The outcome of immune reconstitution was not analyzed by the collaborating laboratory because only a small number of patients were only enrolled in Dose Level 1 (no alemtuzumab). The Dose Level 1 patients were going to be the baseline for which to compare the other patients on Dose Level 2 (and 3) who would have received alemtuzumab. The collaborating investigator determined that the study was not worthwhile performing based on this information.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes >20%.

AML, ALL >5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease.

CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation.

NHL >25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions.

MM

≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.

Outcome measures

Measure	Dose Level 1 (No Campath) n=12 Participants Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
Disease Progression/Relapse	25 percentage of participants	—	—

Adverse Events

Dose Level 1 (No Campath)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Dose Level 2 (40mg Total Dose Campath)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dose Level 3 (60mg Total Dose Campath)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dose Level 1 (No Campath) n=12 participants at risk Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
Respiratory, thoracic and mediastinal disorders Respiratory failure	8.3% 1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Immune system disorders Death due to GVHD	8.3% 1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

Other adverse events

Measure	Dose Level 1 (No Campath) n=12 participants at risk Patients receive fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 2 (40mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -5 and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation	Dose Level 3 (60mg Total Dose Campath) Patients receive alemtuzumab IV over 6 hours once daily on days -6, -5, and -4 and fludarabine phosphate IV over 30 minutes on days -4, -3, and -2. Patients also undergo low-dose TBI on day 0. Alemtuzumab: Given IV Total-body irradiation: Undergo low-dose total-body irradiation Fludarabine phosphate: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation Peripheral blood stem cell transplantation: Undergo peripheral blood stem cell transplantation
Cardiac disorders Acute coronary syndrome	8.3% 1/12 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Investigations Blood bilirubin increased	33.3% 4/12 • Number of events 4 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Investigations Creatinine increased	8.3% 1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Blood and lymphatic system disorders Hemolysis	8.3% 1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Vascular disorders Hypotension	8.3% 1/12 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Respiratory, thoracic and mediastinal disorders Hypoxia	8.3% 1/12 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Nervous system disorders Peripheral motor neuropathy	8.3% 1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Cardiac disorders Ventricular arrhythmia	8.3% 1/12 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200	— 0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200

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