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Phase 2b Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Low to Intermediate-1 Risk, Non-Deletion 5q Myelodysplastic Syndrome


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndrome (MDS)

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Trial Information

Phase 2b Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Low to Intermediate-1 Risk, Non-Deletion 5q Myelodysplastic Syndrome


Inclusion Criteria:



- Primary or de Novo MDS

- Low to Intermediate-1 IPSS risk of MDS

- 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:

- Deletion of the 5q chromosome [del(5q) MDS]

- 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 sterioid use
(such as tapered dosing for an acute non-MDS condition)

- History of hepatitis B or C, or HIV

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Hematologic Improvement-Erythroid (HI-E) rate

Outcome Description:

Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

Outcome Time Frame:

At 8 weeks of treatment

Safety Issue:

No

Principal Investigator

Gail L Brown, MD

Investigator Role:

Study Director

Investigator Affiliation:

Telik

Authority:

United States: Food and Drug Administration

Study ID:

TLK199.2108

NCT ID:

NCT01459159

Start Date:

October 2011

Completion Date:

November 2014

Related Keywords:

  • Myelodysplastic Syndrome (MDS)
  • Hematology
  • MDS
  • Myelodysplastic Syndrome
  • Low risk MDS
  • Int-1 risk MDS
  • Transfusion dependence
  • Telintra
  • ezatiostat
  • ezatiostat hydrochloride
  • TLK199
  • Glutathione
  • Glutathione analog
  • Glutathione Transferase
  • Glutathione Transferase P1-1 inhibitor
  • GST P1-1 inhibitor
  • Apoptosis
  • Differentiation
  • Enzyme inhibitor
  • non-del (5q)
  • non-deletion 5q
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location
University of Colorado Denver, Colorado  80217
Columbia University New York, New York  10032-3784
Vanderbilt University Nashville, Tennessee  37232-6305
Bay Area Cancer Research Group Concord, California  94520
The West Clinic Memphis, Tennessee  38120
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
SIU School of Medicine, Simmons Cancer Institute Springfield, Illinois  62794