Clofarabine Plus Low-Dose Cytarabine for Patients With Higher-Risk Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if clofarabine when given in combination with cytarabine can help to control MDS after the disease could not be controlled with standard therapy. The safety of this treatment will also be studied.
Clofarabine is designed to interfere with the growth and development of cancer cells.
Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Clofarabine Plus Low-Dose Cytarabine for the Treatment of Patients With Higher-Risk Myelodysplastic Syndrome (MDS) Who Have Been Relapsing After, or Are Refractory to, Hypomethylator Therapy|
- Number of Participants with Complete Response (CR) [ Time Frame: 4 weeks after first cycle ] [ Designated as safety issue: No ]Complete Response Criteria (CR must last for at least 4 weeks): Marrow: </= 5% myeloblasts with normal maturation of all cell lines; Persistent dysplasia noted; Blood: Hemoglobin (Hb) >/= 11 g/dL (untransfused, patient not on EPO); Neutrophils >/= 1x109/L (not on myeloid growth factor); Platelets >/= 100 * 109/L (not on thrombopoietic agent); No blasts. Bone marrow aspirate and/or biopsy at the end of course 1 (day 28 +/- 7 days). The method of Thall, Simon, and Estey used to monitor response.
- Overall Survival (OS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Overall survival defined as the time interval from study entry date to the date of death due to any cause, measured in days/months. Bayesian time-to-event model used to monitor overall survival.
|Study Start Date:||November 2011|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Clofarabine + Cytarabine
Clofarabine 10 mg/m2 1-2 hours by vein daily for 5 days (days 1-5) Cytarabine 20 mg subcutaneously twice daily for 7 days (days 1-7)
Clofarabine 10 mg/m2 1-2 hours by vein daily for 3 days (days 1-3) Cytarabine 20 mg subcutaneously twice daily for 5 days (days 1-5)
10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)
10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)
Other Names:Drug: Cytarabine
20 mg subcutaneously twice daily for 7 days (days 1-7)
20 mg subcutaneously twice daily for 5 days (days 1-5)
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|Contact: Guillermo Garcia-Manero, MD||713-745-3428|
|United States, Texas|
|UT MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Guillermo Garcia-Manero, MD||UT MD Anderson Cancer Center|