This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q) Myelodysplastic Syndrome (MDS).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
162
Three weeks of treatment with ezatiostat at 2000 mg per day in divided doses followed by a one week rest period in four-week treatment cycles.
Bay Area Cancer Research Group
Concord, California, United States
University of Colorado
Aurora, Colorado, United States
SIU School of Medicine, Simmons Cancer Institute
Springfield, Illinois, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Hematologic Improvement-Erythroid (HI-E) rate
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Time frame: At 8 weeks of treatment
Hematologic Improvement-Erythroid (HI-E) rate
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Time frame: At 16 weeks of treatment
Hematologic Improvement-Erythroid (HI-E) rate
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Time frame: At 24 weeks of treatment
Hematologic Improvement-Erythroid (HI-E) rate
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Time frame: At 32 weeks of treatment
RBC Transfusion independence (TI) rate
Time frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment
Hematologic Improvement-Neutrophil (HI-N) rate
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Time frame: At 8, 16, 24, & 32 weeks of treatment
Hematologic Improvement-Platelet (HI-P) rate
Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
Time frame: At 8, 16, 24, & 32 weeks of treatment
Unilineage, bilineage, trilineage, and overall HI response rate
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Columbia University
New York, New York, United States
The West Clinic
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
Time frame: 2 years
Cytogenetic response rate
Time frame: 16 weeks, 48 weeks and at the time of first HI response
Duration of response
Time frame: 2 years
Safety of ezatiostat in this MDS population
Recording and grading of AEs using NCI-CTCAE v4.03
Time frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment
Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables
Time frame: 2 years