Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
Myelodysplastic Syndrome (MDS)
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome (MDS) focused on measuring Hematology, MDS, Myelodysplastic Syndrome, Low Risk MDS, Intermediate-1 risk MDS, Int-1 risk MDS, Telintra, ezatiostat hydrochloride, ezatiostat, TLK199, Glutathione, Glutathione analog, Glutathione Transferase, Glutathione Transferase inhibitor, Glutathione Transferase P1-1 inhibitor, GSTp1-1 inhibitor, Apoptosis, Differentiation, Enzyme inhibitor
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Arizona Cancer Center
- Central Hematology Oncology Medical Group, Inc.
- St. Jude Heritage Healthcare
- Wilshire Oncology Medical Group, Inc.
- UCLA Medical Center
- Clinical Trials and Research Associates, Inc.
- North Valley Hematology/Oncology Medical Group
- Bay Area Cancer Research Group
- Desert Hematology Oncology Medical Group
- Cancer Care Associates Medical Group, Inc.
- Sansum Clinic
- Santa Barbara Hematology Medical Group, Inc.
- Central Coast Medical Oncology Corporation
- University of Colorado at Denver Health Sciences Center
- The Center for Hematology Oncology
- Lakeland Regional Cancer Center
- Moffitt Cancer Center
- Northeast Georgia Cancer Care, LLC
- Suburban Hematology-Oncology Associates, P.C.
- Joliet Oncology-Hematology Associates, Ltd.
- Loyola University Chicago
- Southern Illinois University School of Medicine
- Central Hematology Oncology Medical Group, Inc.
- Center for Cancer and Blood Disorders
- Comprehensive Cancer Centers of Nevada
- Cancer Institute of New Jersey
- St. Vincent's Comprehensive Cancer Center
- University of Rochester Medical Center
- Case Western Reserve University/University Hospitals of Cleveland
- Hematology & Medical Oncology
- The University of Oklahoma Health Sciences Center
- Cancer Care Associates
- Cancer Care Associates
- Kaiser Permanente
- MD Anderson Cancer Center
- Cancer Care Centers of South Texas
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1
2
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.
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.