Myelodysplastic Syndrome
Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Eligibility Criteria (per protocol dated 09/26/08):
- Histologically confirmed diagnosis of primary or de novo MDS using the World Health Organization classification.
- Low or Intermediate-1 risk using the International Prognostic Scoring System (IPSS).
- ECOG Performance status of 0 or 1.
- Prior treatment with experimental or conventional treatment other than blood products (ie, chemotherapeutic, immunosuppressive, cytoprotective or demethylating agents). At least a 4-week (28 days) washout period is required.
- Adequate organ function, as determined by the protocol.
- Not eligible if there is prior allogenic bone marrow transplant for MDS.
- Not eligible if there is a history of MDS IPSS score of more than 1.0.
- Not eligible if there is leptomeningeal or leukemic meningitis.
- Not eligible if there is any severe concurrent disease, infection, or comorbidity that, in the opinion of the investigator, would make the subject inappropriate for the study.
- Other criteria, as determined by the protocol.
For information about this study, please contact Robin Stewart, RN, PhD, CCRC at (863) 904-1877.