Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome
Sponsored by Telik
About this trial
Last updated 12 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 12 years ago
What is this trial about?
What are the participation requirements?
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