Clofarabine, Cytarabine, and Thymoglobulin for Allogeneic Transplantation
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|ClinicalTrials.gov Identifier: NCT00593645|
Recruitment Status : Terminated (toxicities were worse than expected)
First Posted : January 15, 2008
Results First Posted : September 12, 2014
Last Update Posted : September 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndromes Acute Myeloid Leukemia||Drug: Clofarabine Drug: Cytarabine Drug: Thymoglobulin Procedure: Stem cell infusion||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Non-Myeloablative Conditioning Regimen for Allogeneic Transplantation With Clofarabine, Cytarabine, and Thymoglobulin for Myelodysplastic Syndrome and Acute Myeloid Leukemia|
|Study Start Date :||November 2007|
|Primary Completion Date :||December 2008|
|Study Completion Date :||July 2009|
Experimental: Arm 1: Non-myeloablative conditioning regimen
Other Name: ClolarDrug: Cytarabine
Other Names:Drug: Thymoglobulin
Other Name: Anti-thymocyte globulinProcedure: Stem cell infusion
- Six-month Treatment Related Mortality [ Time Frame: 6 months ]
- Disease Specific Response Rates [ Time Frame: One, three, six and twelve months. ]Disease-specific partial response and complete response.
- Engraftment as Measured by Percent Donor Chimerism [ Time Frame: Day +30 ]
- Engraftment as Measured by Percent Donor Chimerism [ Time Frame: Day +40-+60 ]
- Engraftment as Measured by Percent Donor Chimerism [ Time Frame: Day +80-+90 ]
- Overall Survival [ Time Frame: 5 years from time of restaging ]
- Disease-free Survival [ Time Frame: 5 years from time of restaging ]Disease-free survival is defined as the length of time after treatment ends that the participant survives without any signs or symptoms of that cancer.
- Rate of Acute Graft-versus-host Disease (GVHD) [ Time Frame: Up to 100 days after transplant ]Acute GVHD occurs within 100 days of transplant.
- Rate of Chronic Graft-versus-host Disease (GVHD) [ Time Frame: 100 days-1 year after transplant ]
- Use Conventional STR-PCR Method for Monitoring Engraftment [ Time Frame: Up to 1 year after transplant ]Includes assessment of mixed chimerism in the whole blood, myeloid cells, T cells, and B cells.
- Median Time to Progression [ Time Frame: 5 years from time of restaging ]Time to progression is defined as the length of time from the start of treatment until the disease starts to get worse or spread to other parts of the body.
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): NCT00593645
|United States, Missouri|
|Ravi Vij, M.D.|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Ravi Vij, M.D.||Washington Universtiy of St. Louis|