Autologous Stem Cell Transplants for Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00446173|
Recruitment Status : Withdrawn (Terminated due to low accrual.)
First Posted : March 12, 2007
Last Update Posted : August 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: Busulfan Drug: Cyclophosphamide Drug: G-CSF Drug: GM-CSF||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Purged Hematopoietic Stem Cell Transplantation for Chronic Myelogenous Leukemia (CML)|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||January 2009|
|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
- Time to absolute neutrophil count (ANC) recovery to 500 [ Time Frame: 30 Days ]
- Survival Time [ Time Frame: 30 Days (Success Rate + ANC Recovery to 500) ]
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): 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|