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 |
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
We found this trial at
7
sites
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Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Center for Cancer & Blood Disorders Widely recognized for its compassionate, expert care, the Center...
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The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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