Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
- Registration Number
- NCT00700206
- Lead Sponsor
- Telik
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
- Primary or de novo MDS
- Low or intermediate-1 MDS
- ECOG performance status 0 or 1
- Documented significant anemia with or without neutropenia and/or thrombocytopenia
- Adequate kidney and liver function
- Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry
- Prior allogenic bone marrow transplant for MDS
- History of MDS IPSS score greater than 1.0
- Pregnant or lactating women
- Any severe concurrent disease, infection, or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
- Oral steroids e.g. prednisone >10 mg per day
- History of active hepatitis B or C
- Known history of HIV
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Ezatiostat Hydrochloride Dose Schedule 1: Two weeks treatment with Telintra 3000 mg per day in two divided doses followed by one week with no treatment per three week cycle. 2 Ezatiostat Hydrochloride Dose Schedule 2: Three weeks treatment with Telintra 2000 mg per day in two divided doses followed by one week with no treatment per four week cycle.
- Primary Outcome Measures
Name Time Method Hematologic Improvement-Erythroid (HI-E) rate 24 Weeks
- Secondary Outcome Measures
Name Time Method Hematologic Improvement-Neutrophil (HI-N) rate, the Hematologic Improvement-Platelet (HI-P) rate, overall hematologic response rate, safety profile and Quality of Life assessments. 24 Weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (34)
Santa Barbara Hematology Medical Group, Inc.
🇺🇸Santa Barbara, California, United States
The Center for Hematology Oncology
🇺🇸Boca Raton, Florida, United States
Cancer Care Associates Medical Group, Inc.
🇺🇸Redondo Beach, California, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Northeast Georgia Cancer Care, LLC
🇺🇸Athens, Georgia, United States
Lakeland Regional Cancer Center
🇺🇸Lakeland, Florida, United States
Clinical Trials and Research Associates, Inc.
🇺🇸Montebello, California, United States
St. Vincent's Comprehensive Cancer Center
🇺🇸New York, New York, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, 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
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Kaiser Permanente
🇺🇸Portland, Oregon, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
Wilshire Oncology Medical Group, Inc.
🇺🇸La Verne, California, United States
St. Jude Heritage Healthcare
🇺🇸Fullerton, California, United States
Central Hematology Oncology Medical Group, Inc.
🇺🇸Terre Haute, Indiana, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
North Valley Hematology/Oncology Medical Group
🇺🇸Northridge, California, United States
Desert Hematology Oncology Medical Group
🇺🇸Rancho Mirage, California, United States
University of Colorado at Denver Health Sciences Center
🇺🇸Aurora, Colorado, United States
Joliet Oncology-Hematology Associates, Ltd.
🇺🇸Joliet, Illinois, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
Suburban Hematology-Oncology Associates, P.C.
🇺🇸Lawrenceville, Georgia, United States
Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Bay Area Cancer Research Group
🇺🇸Pleasant Hill, California, United States
Loyola University Chicago
🇺🇸Maywood, Illinois, United States