Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
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|ClinicalTrials.gov Identifier: NCT00555048|
Recruitment Status : Terminated (Low accrual)
First Posted : November 7, 2007
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening.
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.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Biological: alemtuzumab Drug: busulfan Drug: cyclophosphamide Drug: methotrexate Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation||Phase 1 Phase 2|
- Identify the lowest dose of alemtuzumab that is associated with day 180 transplant-related mortality ≤ 45%.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Official Title:||A Prospective Trial to Evaluate the Role of In Vivo T Cell Depletion by Campath® (Alemtuzumab) in Reduction of Transplant Related Mortality in Transplantation From HLA-Class I or Class II Mismatched, Unrelated Donors|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||October 2010|
Alemtuzumab given together with busulfan and cyclophosphamide followed by a donor stem cell transplant.
|Biological: alemtuzumab Drug: busulfan Drug: cyclophosphamide Drug: methotrexate Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation|
- Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality [ Time Frame: Up to day 180 ]Lowest dose of alemtuzumab associated with transplant-related mortality at day 180
- Life-threatening Infection [ Time Frame: Up to 180 days ]
- Grades III-IV Acute Graft-vs-host Disease (GVHD) [ Time Frame: Up to 100 days ]
- Overall Survival [ Time Frame: Up to 1 year ]Count of surviving participants at 1 year
- Disease Relapse [ Time Frame: Up to 1 year ]Count of participants with disease relapse at 1 year
- Extensive Chronic GVHD [ Time Frame: Up to 1 year ]Count of participants with extensive chronic GVHD at 1 year
- Graft Failure [ Time Frame: Up to day 100 ]Count of participants with graft failure at day 100
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555048
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98104-1024|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109-1023|
|Principal Investigator:||Ann E. Woolfrey, MD||Fred Hutchinson Cancer Research Center|