Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia
1. To study ex-vivo purging of autologous hematopoietic stem cells that will be used to support high-dose chemotherapy in patients with chronic myelogenous leukemia (CML). Major endpoints are neutrophil engraftment and survival.
- To evaluate the toxicity of ex-vivo purged autologous cells when used to support high-dose chemotherapy.
- To evaluate the rate and duration of cytogenetic remissions achieved with this strategy.
- To determine the time to platelet recovery to 20,000/mm3.
- To determine the one-year survival rate.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous Purged Hematopoietic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)|
- Time to absolute neutrophil count (ANC) recovery to 500 [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Survival Time [ Time Frame: 30 Days (Success Rate + ANC Recovery to 500) ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
|Experimental: Busulfan + Cyclophosphamide + G-CSF + GM-CSF||
130 mg/m^2 IV Daily Over 3 Hours x 4 Days
Other Names:Drug: Cyclophosphamide
60 mg/kg IV Daily Over 4 Hours x 2 Days
Other Names:Drug: G-CSF
10 mcg/kg Subcutaneously Once Daily
Other Names:Drug: GM-CSF
250 mcg/kg Subcutaneously Once Daily
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00446173
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Marcos de Lima, MD||M.D. Anderson Cancer Center|