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

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ClinicalTrials.gov Identifier: NCT01459159
Recruitment Status : Terminated (Study TLK199.2108 was terminated for business reasons.)
First Posted : October 25, 2011
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Myelodysplastic Syndrome (MDS) Drug: ezatiostat hydrochloride (Telintra®) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 8 weeks of treatment ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

  2. Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 16 weeks of treatment ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

  3. Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 24 weeks of treatment ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

  4. Hematologic Improvement-Erythroid (HI-E) rate [ Time Frame: At 32 weeks of treatment ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)


Secondary Outcome Measures :
  1. RBC Transfusion independence (TI) rate [ Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment ]
  2. Hematologic Improvement-Neutrophil (HI-N) rate [ Time Frame: At 8, 16, 24, & 32 weeks of treatment ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

  3. Hematologic Improvement-Platelet (HI-P) rate [ Time Frame: At 8, 16, 24, & 32 weeks of treatment ]
    Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)

  4. Unilineage, bilineage, trilineage, and overall HI response rate [ Time Frame: 2 years ]
  5. Cytogenetic response rate [ Time Frame: 16 weeks, 48 weeks and at the time of first HI response ]
  6. Duration of response [ Time Frame: 2 years ]
  7. Safety of ezatiostat in this MDS population [ Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment ]
    Recording and grading of AEs using NCI-CTCAE v4.03

  8. Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables [ Time Frame: 2 years ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT01459159     History of Changes
Other Study ID Numbers: TLK199.2108
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

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:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms