Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
NCT ID: NCT00555048
Last Updated: 2017-05-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
1 participants
INTERVENTIONAL
2007-09-30
Brief Summary
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PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how well it works in treating patients with hematologic cancer.
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Detailed Description
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Primary
* Identify the lowest dose of alemtuzumab that is associated with day 180 transplant-related mortality ≤ 45%.
Secondary
* Determine the incidence of life-threatening infection in patients receiving this treatment.
* Determine the incidence of grades III-IV acute graft-vs-host disease (GVHD) in patients receiving this treatment.
* Determine the survival at 1 year in patients receiving this treatment.
* Determine the incidence of disease relapse at 1 year in patients receiving this treatment.
* Determine the incidence of extensive chronic GVHD at 1 year in patients receiving this treatment.
* Determine the incidence of graft failure at day 100 in patients receiving this treatment.
OUTLINE:
* Chemotherapy: Patients receive alemtuzumab IV over 2 hours on days -10 to -6, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV on days -3 and -2.
* Peripheral blood stem cell (PBSC) transplantation: Patients undergo allogeneic filgrastim (G-CSF)-mobilized PBSC transplantation on day 0.
* Graft-vs-host disease prophylaxis: Patients receive tacrolimus IV continuously or orally twice daily on days -1 to 50 and methotrexate IV on days 1, 3, 6, and 11.
After completion of study therapy, patients are followed periodically.
Conditions
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Study Design
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TREATMENT
Study Groups
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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
Interventions
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alemtuzumab
busulfan
cyclophosphamide
methotrexate
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Ann Woolfrey
Principal Investigator
Principal Investigators
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Ann E. Woolfrey, MD
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Center
Locations
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Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
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Other Identifiers
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FHCRC-1981.00
Identifier Type: -
Identifier Source: secondary_id
CDR0000574145
Identifier Type: REGISTRY
Identifier Source: secondary_id
1981.00
Identifier Type: -
Identifier Source: org_study_id
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