Myelodysplastic Syndrome Clinical Trial
Phase 2 Study Comparing Two Dose Schedules of Telintraâ„¢ in Myelodysplastic Syndrome (MDS)
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.
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
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There are 35 Locations for this study
Tucson Arizona, 85724, United States
Alhambra California, 91801, United States
Fullerton California, 92835, United States
La Verne California, 91750, United States
Los Angeles California, 90095, United States
Montebello California, 90640, United States
Northridge California, 91325, United States
Pleasant Hill California, 94523, United States
Rancho Mirage California, 92270, United States
Redondo Beach California, 92077, United States
Santa Barbara California, 93105, United States
Santa Barbara California, 93105, United States
Santa Maria California, 93454, United States
Aurora Colorado, 80445, United States
Boca Raton Florida, 33486, United States
Lakeland Florida, 33805, United States
Tampa Florida, 33612, United States
Athens Georgia, 30607, United States
Lawrenceville Georgia, 30045, United States
Joliet Illinois, 60435, United States
Maywood Illinois, 60153, United States
Springfield Illinois, 62702, United States
Terre Haute Indiana, 47802, United States
Bethesda Maryland, 20817, United States
Henderson Nevada, 89052, United States
New Brunswick New Jersey, 08901, United States
New York New York, 10011, United States
Rochester New York, 14642, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Oklahoma City Oklahoma, 73104, United States
Oklahoma City Oklahoma, 73112, United States
Tulsa Oklahoma, 74136, United States
Portland Oregon, 97227, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
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