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Brief Title: Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
Official Title: Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Study ID: NCT00700206
Brief Summary: This is a randomized, open label, multicenter, Phase 2 study comparing two dose schedules of Telintra in patients with Low or Intermediate-1 risk MDS. Patients at least 18 years of age presenting with histologically confirmed Low to Intermediate-1 risk MDS with documented significant cytopenia for at least two months by the IWG criteria are eligible.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Arizona Cancer Center, Tucson, Arizona, United States
Central Hematology Oncology Medical Group, Inc., Alhambra, California, United States
St. Jude Heritage Healthcare, Fullerton, California, United States
Wilshire Oncology Medical Group, Inc., La Verne, California, United States
UCLA Medical Center, Los Angeles, California, United States
Clinical Trials and Research Associates, Inc., Montebello, California, United States
North Valley Hematology/Oncology Medical Group, Northridge, California, United States
Bay Area Cancer Research Group, Pleasant Hill, California, United States
Desert Hematology Oncology Medical Group, Rancho Mirage, California, United States
Cancer Care Associates Medical Group, Inc., Redondo Beach, California, United States
Sansum Clinic, Santa Barbara, California, United States
Santa Barbara Hematology Medical Group, Inc., Santa Barbara, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
University of Colorado at Denver Health Sciences Center, Aurora, Colorado, United States
The Center for Hematology Oncology, Boca Raton, Florida, United States
Lakeland Regional Cancer Center, Lakeland, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Northeast Georgia Cancer Care, LLC, Athens, Georgia, United States
Suburban Hematology-Oncology Associates, P.C., Lawrenceville, Georgia, United States
Joliet Oncology-Hematology Associates, Ltd., Joliet, Illinois, United States
Loyola University Chicago, Maywood, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Central Hematology Oncology Medical Group, Inc., Terre Haute, Indiana, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
St. Vincent's Comprehensive Cancer Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Case Western Reserve University/University Hospitals of Cleveland, Cleveland, Ohio, United States
Hematology & Medical Oncology, Cleveland, Ohio, United States
The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Cancer Care Associates, Oklahoma City, Oklahoma, United States
Cancer Care Associates, Tulsa, Oklahoma, United States
Kaiser Permanente, Portland, Oregon, United States
MD Anderson Cancer Center, Houston, Texas, United States
Cancer Care Centers of South Texas, San Antonio, Texas, United States
Name: Gail Brown, MD
Affiliation: Telik
Role: STUDY_DIRECTOR