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



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:October 2011
End Date:November 2014
Contact:Shelby Young, RN
Email:syoung@telik.com
Phone:650-845-7761

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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


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).


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
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Aurora, CO
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6410 Rockledge Dr #660
Bethesda, Maryland 20817
(301) 571-0019
Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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Bethesda, MD
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Concord, California 94520
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Concord, CA
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100 N Humphreys Blvd
Memphis, Tennessee 38120
(901) 683-0055
The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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Memphis, TN
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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