Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome

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

Summary

Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome (MDS).

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

Details

• Lead Sponsor: Telik
• Treatments: Lenalidomide

Criteria

Inclusion Criteria:

• Primary or de Novo MDS

• Low or Intermediate-1 IPSS risk MDS

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

• Refractory or resistant to lenalidomide (Revlimid)

• 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:

• 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 steroid use (such as tapered dosing for an acute non-MDS condition)

• History of hepatitis B or C, or HIV