Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome

This study has been terminated.
(Study TLK199.2108 was terminated for business reasons.)
Sponsor:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT01459159
First received: October 11, 2011
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

This is a multicenter, single arm open label Phase 2b Study of oral ezatiostat (Telintra®) in Patients who are RBC tranfusion dependent, Low to INT-1 IPSS risk, non-del (5q) Myelodysplastic Syndrome (MDS).


Condition Intervention Phase
Myelodysplastic Syndrome (MDS)
Drug: ezatiostat hydrochloride (Telintra®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2b Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Low to Intermediate-1 Risk, Non-Deletion 5q Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by Telik:

Primary Outcome Measures:
  • Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 8 weeks of treatment ] [ Designated as safety issue: No ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

  • Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 16 weeks of treatment ] [ Designated as safety issue: No ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

  • Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 24 weeks of treatment ] [ Designated as safety issue: No ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

  • Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 32 weeks of treatment ] [ Designated as safety issue: No ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)


Secondary Outcome Measures:
  • RBC Transfusion independence (TI) rate [ Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment ] [ Designated as safety issue: No ]
  • Hematologic Improvement-Neutrophil (HI-N) rate [ Time Frame: At 8, 16, 24, & 32 weeks of treatment ] [ Designated as safety issue: No ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

  • Hematologic Improvement-Platelet (HI-P) rate [ Time Frame: At 8, 16, 24, & 32 weeks of treatment ] [ Designated as safety issue: No ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

  • Unilineage, bilineage, trilineage, and overall HI response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cytogenetic response rate [ Time Frame: 16 weeks, 48 weeks and at the time of first HI response ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety of ezatiostat in this MDS population [ Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment ] [ Designated as safety issue: No ]
    Recording and grading of AEs using NCI-CTCAE v4.03

  • Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 162
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ezatiostat hydrochloride (Telintra®)
    Three weeks of treatment with ezatiostat at 2000 mg per day in divided doses followed by a one week rest period in four-week treatment cycles.
    Other Names:
    • Telintra
    • Telintra Tablets
    • Oral Telintra
    • ezatiostat
    • ezatiostat hydrochloride
    • oral ezatiostat
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459159

Locations
United States, California
Bay Area Cancer Research Group
Concord, California, United States, 94520
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Illinois
SIU School of Medicine, Simmons Cancer Institute
Springfield, Illinois, United States, 62794
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Telik
Investigators
Study Director: Gail L Brown, MD Telik
  More Information

No publications provided

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT01459159     History of Changes
Other Study ID Numbers: TLK199.2108
Study First Received: October 11, 2011
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Telik:
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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on September 14, 2014