Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telik

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