Phase 2 Study Comparing Two Dose Schedules of Telintra™ in Myelodysplastic Syndrome (MDS)

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00700206

Enrollment

Registered

2008-06-18

Start date

2008-05-31

Completion date

2011-07-31

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndrome (MDS)

Keywords

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

Brief summary

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.

Interventions

DRUGEzatiostat Hydrochloride

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hematologic Improvement-Erythroid (HI-E) rate	24 Weeks

Secondary

Measure	Time frame
Hematologic Improvement-Neutrophil (HI-N) rate, the Hematologic Improvement-Platelet (HI-P) rate, overall hematologic response rate, safety profile and Quality of Life assessments.	24 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026