Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant
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|ClinicalTrials.gov Identifier: NCT00343785|
Recruitment Status : Completed
First Posted : June 23, 2006
Results First Posted : March 16, 2017
Last Update Posted : April 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Aplastic Anemia||Drug: cyclophosphamide Biological: anti-thymocyte globulin Drug: cyclosporine Procedure: allogeneic bone marrow transplantation Drug: methotrexate Genetic: DNA analysis Other: flow cytometry Genetic: polymorphism analysis Other: laboratory biomarker analysis||Phase 2|
I. Minimize the incidence of chronic GVHD by restricting the transplanted marrow dose to 2.0-2.5 x 10^8 nucleated cells/kg.
I. Engraftment and overall survival.
CONDITIONING REGIMEN: Patients receive cyclophosphamide intravenously (IV) on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2.
TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or orally (PO) twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
After completion of study treatment, patients are followed up at on day 180, 1 year, 1.5 years, 2 years, 3 years, and yearly thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center Trial|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||August 2012|
Experimental: Treatment (conditioning regimen, transplant, GVHD prophylaxis)
Patients receive a conditioning regimen comprising cyclophosphamide IV on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. Patients undergo allogeneic bone marrow transplantation on day 0. Patients then receive GVHD prophylaxis comprising methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or PO twice daily on days -1 to 50, followed by a taper until 6 months after grafting.
Biological: anti-thymocyte globulin
Given IV or PO
Procedure: allogeneic bone marrow transplantation
Undergo allogeneic bone marrow transplantation
Genetic: DNA analysis
Other: flow cytometry
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
- Incidence of Chronic GVHD [ Time Frame: 2 years ]Analyzed using cumulative incidence estimates, treating death or rejection as competing risk events.
- Number of Days to Neutrophil Recovery to >500/uL [ Time Frame: 100 days post-transplant ]First of 3 consecutive days of neutrophils >500/uL
- Overall Survival [ Time Frame: From the time of enrollment until death from any cause up to one year ]Number of patients alive at one year
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): NCT00343785
|United States, Utah|
|Huntsman Cancer Institute/University of Utah|
|Salt Lake City, Utah, United States, 84112|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|United States, Wisconsin|
|Froedtert and the Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Rainer Storb||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|