NCT00700206
Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)
PHASE2
COMPLETED
NCT00700206
INTERVENTIONAL
Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
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.
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
Myelodysplastic Syndrome (MDS)
- TREATMENT
-
- Type: DRUG
- Name: Ezatiostat Hydrochloride
- Description: Dose Schedule 1-3000 mg orally per day in two divided doses for two weeks followed by 1 week with no treatment per three week cycle. Dose Schedule 2-2000 mg orally per day in two divided doses for three weeks followed by 1 week with no treatment per four week cycle.
- Arm Group Labels: 1, 2
- Telik