This is an open label, multicenter Phase 1 dose escalation study evaluating five doses of ezatiostat in combination with lenalidomide in patients with non-del(5q) low to intermediate 1 risk MDS. The HI-E, HI-N, HI-P rates \[by International Working Group (IWG) 2006 criteria\] and safety of each treatment group will be evaluated to select the optimal dose of ezatiostat in combination with lenalidomide for future studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Starting dose 2000 mg orally in divided doses twice daily (1000 mg in AM \& 1000 mg in PM) x 21 days with one week off therapy in a 4-week cycle.
10 mg orally per day in one AM dose x 21 days with one week off therapy in a 4-week cycle.
Mayo Clinic
Phoenix, Arizona, United States
Loyola University Chicago Cardinal Benardin Cancer Center
Maywood, Illinois, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
Dana Farber Cancer Institute
To establish the maximum tolerated dose (MTD) of ezatiostat in combination with lenalidomide
Time frame: 2 years
To determine the safety of ezatiostat in combination with lenalidomide
Time frame: 2 years
To determine the efficacy of ezatiosate in combination wiht lenalidomide in patients with non-del(5q) low to intermediate-1 risk of MDS
Time frame: 2 years
Hematologic Improvement-Erythroid (HI-E) rate
Time frame: 2 years
Hematologic Improvement-Neutrophil (HI-N) rate
Time frame: 2 years
Hematologic Improvement-Platelet (HI-P) rate
Time frame: 2 years
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Boston, Massachusetts, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
MDAnderson
Houston, Texas, United States
Cancer Care Centers of South Texas
San Antonio, Texas, United States