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Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Phase 2
18 Years
Not Enrolling
Myelodysplastic Syndrome (MDS)

Thank you

Trial Information

Phase 2 Randomized Study Comparing Two Dose Schedules of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) in Low to Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Hematologic Improvement-Erythroid (HI-E) rate

Outcome Time Frame:

24 Weeks

Safety Issue:


Principal Investigator

Gail Brown, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2008

Completion Date:

July 2011

Related Keywords:

  • Myelodysplastic Syndrome (MDS)
  • Hematology
  • MDS
  • Myelodysplastic Syndrome
  • Low Risk MDS
  • Intermediate-1 risk MDS
  • Int-1 risk MDS
  • Telintra
  • ezatiostat hydrochloride
  • ezatiostat
  • TLK199
  • Glutathione
  • Glutathione analog
  • Glutathione Transferase
  • Glutathione Transferase inhibitor
  • Glutathione Transferase P1-1 inhibitor
  • GSTp1-1 inhibitor
  • Apoptosis
  • Differentiation
  • Enzyme inhibitor
  • Myelodysplastic Syndromes
  • Preleukemia



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