Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)
The goal of this clinical research study is to learn if Vidaza (azacitidine) when given to patients with CML after an donor stem cell transplant will increase the likelihood of achieving a complete remission of CML.
Stem Cell Transplantation
Procedure: Stem Cell Transplant
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Azacitidine Maintenance Therapy After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)|
- Complete Molecular Remission Rate [ Time Frame: 1 Month ] [ Designated as safety issue: No ]Molecular Remission defined as 2 negative consecutive quantitative PCR tests done with a sensitivity of at least 1 in 105 cells, done at least one month apart.
|Study Start Date:||December 2008|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Azacytidine Maintenance after allotx
Busulfan + Fludarabine + ATG + Azacytidine after allogeneic stem cell transplantation (allotx)
40 mg/m^2 by vein over 60 minutes on Day -5 through Day -2.
Other Name: Fludarabine PhosphateDrug: Busulfan
Busulfan administered at the dose calculated to achieve an AUC of 4000 µMol-min + 12% based on the pharmacokinetic studies (days -5, -4, -3, and -2).
Other Names:Drug: Thymoglobulin
2.5 mg/kg by vein over about 4-6 hours on Day -3 through Day -1.
Other Names:Drug: Azacitidine
Start cycles of 32 mg/m^2 daily as an injection under the skin once a day over 5 days in a row, starting about 5 weeks after the transplant. This may be repeated once a month for up to 4 months after the transplant.
Other Names:Procedure: Stem Cell Transplant
Stem cell infusion on day 0 administered by vein after collected from donor.
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Richard E. Champlin, MD, BS||UT MD Anderson Cancer Center|