Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)
|ClinicalTrials.gov Identifier: NCT00813124|
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : October 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stem Cell Transplantation Leukemia||Drug: Fludarabine Drug: Busulfan Drug: Thymoglobulin Drug: Azacitidine Procedure: Stem Cell Transplant||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Azacitidine Maintenance Therapy After Allogeneic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||September 2014|
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 area under curve (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.
- Complete Molecular Remission Rate [ Time Frame: 1 Month ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813124
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Richard E. Champlin, MD, BS||M.D. Anderson Cancer Center|