Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q) Myelodysplastic Syndrome (MDS).

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

Details

• Lead Sponsor: Telik

Criteria

Inclusion Criteria:

• Primary or de Novo MDS

• Low to Intermediate-1 IPSS risk of MDS

• ECOG performance score of 0 or 1

• Documentation of significant anemia with or without additional cytopenia

• Adequate kidney and liver function

• Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry

Exclusion Criteria:

• Deletion of the 5q chromosome [del(5q) MDS]

• Prior allogenic bone marrow transplant for MDS

• Known sensitivity to ezatiostat (injection or oral tablets)

• Prior treatment with hypomethylating agent (HMA) (e.g., azacitadine, decitabine)

• History of MDS IPSS risk score of 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 greater than 10 mg per day. Exceptions: those prescribed for other conditions (such as new adrenal failure, asthma, arthritis) or brief sterioid use (such as tapered dosing for an acute non-MDS condition)

• History of hepatitis B or C, or HIV