Trial Outcomes & Findings for Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer (NCT NCT00555048)

Results Overview

Lowest dose of alemtuzumab associated with transplant-related mortality at day 180

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Up to day 180

Results posted on

2017-05-24

Participant Flow

Participant milestones

Participant milestones
Measure	Alemtuzumab Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. alemtuzumab busulfan cyclophosphamide methotrexate tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alemtuzumab n=1 Participants Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. alemtuzumab busulfan cyclophosphamide methotrexate tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Age, Continuous	47 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to day 180

Lowest dose of alemtuzumab associated with transplant-related mortality at day 180

Outcome measures

Outcome measures
Measure	Alemtuzumab n=1 Participants Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. alemtuzumab busulfan cyclophosphamide methotrexate tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality	40 mg total dose

SECONDARY outcome

Timeframe: Up to 180 days

Outcome measures

Outcome measures
Measure	Alemtuzumab n=1 Participants Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. alemtuzumab busulfan cyclophosphamide methotrexate tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Life-threatening Infection	0 Participants

SECONDARY outcome

Timeframe: Up to 100 days

Outcome measures

Outcome measures
Measure	Alemtuzumab n=1 Participants Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. alemtuzumab busulfan cyclophosphamide methotrexate tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Grades III-IV Acute Graft-vs-host Disease (GVHD)	0 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Count of surviving participants at 1 year

Outcome measures

Outcome measures
Measure	Alemtuzumab n=1 Participants Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. alemtuzumab busulfan cyclophosphamide methotrexate tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Overall Survival	1 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Count of participants with disease relapse at 1 year

Outcome measures

Outcome measures
Measure	Alemtuzumab n=1 Participants Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. alemtuzumab busulfan cyclophosphamide methotrexate tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Disease Relapse	0 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Count of participants with extensive chronic GVHD at 1 year

Outcome measures

Outcome measures
Measure	Alemtuzumab n=1 Participants Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. alemtuzumab busulfan cyclophosphamide methotrexate tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Extensive Chronic GVHD	1 Participants

SECONDARY outcome

Timeframe: Up to day 100

Count of participants with graft failure at day 100

Outcome measures

Outcome measures
Measure	Alemtuzumab n=1 Participants Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant. alemtuzumab busulfan cyclophosphamide methotrexate tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation
Graft Failure	0 Participants

Adverse Events

Alemtuzumab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ann Woolfrey, MD

Fred Hutchinson Cancer Research Center

Phone: 206-667-4453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place