- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01459159
Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome
November 20, 2013 updated by: Telik
Phase 2b Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Low to Intermediate-1 Risk, Non-Deletion 5q Myelodysplastic Syndrome
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
162
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Concord, California, United States, 94520
- Bay Area Cancer Research Group
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Illinois
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Springfield, Illinois, United States, 62794
- SIU School of Medicine, Simmons Cancer Institute
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Maryland
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Bethesda, Maryland, United States, 20817
- Center For Cancer and Blood Disorders
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New York
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New York, New York, United States, 10032
- Columbia University
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Tennessee
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Memphis, Tennessee, United States, 38120
- The West Clinic
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Nashville, Tennessee, United States, 37232
- Vanderbilt University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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At 8 weeks of treatment
|
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)
|
At 16 weeks of treatment
|
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)
|
At 24 weeks of treatment
|
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)
|
At 32 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of response
Time Frame: 2 years
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2 years
|
|
RBC Transfusion independence (TI) rate
Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment
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At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment
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|
Hematologic Improvement-Neutrophil (HI-N) rate
Time Frame: At 8, 16, 24, & 32 weeks of treatment
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Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
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At 8, 16, 24, & 32 weeks of treatment
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Hematologic Improvement-Platelet (HI-P) rate
Time Frame: At 8, 16, 24, & 32 weeks of treatment
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Hematologic Improvement response will be assessed per the IWG MDS response criteria (2006)
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At 8, 16, 24, & 32 weeks of treatment
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Unilineage, bilineage, trilineage, and overall HI response rate
Time Frame: 2 years
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2 years
|
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Cytogenetic response rate
Time Frame: 16 weeks, 48 weeks and at the time of first HI response
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16 weeks, 48 weeks and at the time of first HI response
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Safety of ezatiostat in this MDS population
Time Frame: At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment
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Recording and grading of AEs using NCI-CTCAE v4.03
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At 4, 8, 12, 16, 20, 24, 28 & 32 weeks of treatment
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Evaluation of the relationship between HI-E response, gene expression profiling and response-related variables
Time Frame: 2 years
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gail L Brown, MD, Telik
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (ACTUAL)
February 1, 2013
Study Completion (ACTUAL)
February 1, 2013
Study Registration Dates
First Submitted
October 11, 2011
First Submitted That Met QC Criteria
October 21, 2011
First Posted (ESTIMATE)
October 25, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
November 25, 2013
Last Update Submitted That Met QC Criteria
November 20, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
- MDS
- Hematology
- Myelodysplastic Syndrome
- Glutathione
- Apoptosis
- Differentiation
- Int-1 risk MDS
- Telintra
- ezatiostat hydrochloride
- ezatiostat
- TLK199
- Glutathione analog
- Glutathione Transferase
- Glutathione Transferase P1-1 inhibitor
- Enzyme inhibitor
- Low risk MDS
- Transfusion dependence
- GST P1-1 inhibitor
- non-del (5q)
- non-deletion 5q
Additional Relevant MeSH Terms
Other Study ID Numbers
- TLK199.2108
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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