Clofarabine Plus Low-Dose Cytarabine for Patients With Higher-Risk Myelodysplastic Syndrome (MDS)
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|ClinicalTrials.gov Identifier: NCT01444742|
Recruitment Status : Completed
First Posted : October 3, 2011
Results First Posted : May 31, 2018
Last Update Posted : July 3, 2018
The goal of this clinical research study is to learn if clofarabine when given in combination with cytarabine can help to control myelodysplastic syndrome (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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myeloproliferative Diseases||Drug: Clofarabine Drug: Cytarabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 16, 2011|
|Actual Primary Completion Date :||January 29, 2017|
|Actual Study Completion Date :||January 29, 2017|
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)
20 mg subcutaneously twice daily for 7 days (days 1-7)
20 mg subcutaneously twice daily for 5 days (days 1-5)
- Number of Participants With Complete Response (CR) [ Time Frame: 4 weeks after first cycle ]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: 5 years ]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.
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): NCT01444742
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Guillermo Garcia-Manero, MD||M.D. Anderson Cancer Center|