Status:
TERMINATED
Study of (Telintra®) in Non-Del(5q) Myelodysplastic Syndrome
Lead Sponsor:
Telik
Conditions:
Myelodysplastic Syndrome (MDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT01459159
Start Date
October 1 2011
End Date
February 1 2013
Last Update
November 25 2013
Active Locations (7)
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1
Bay Area Cancer Research Group
Concord, California, United States, 94520
2
University of Colorado
Aurora, Colorado, United States, 80045
3
SIU School of Medicine, Simmons Cancer Institute
Springfield, Illinois, United States, 62794
4
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817