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).
Drug: ezatiostat hydrochloride (Telintra®)
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01459159
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01459159
United States (7)
Bay Area Cancer Research Group
Concord, California, United States, 94520
University of Colorado
Aurora, Colorado, United States, 80045
SIU School of Medicine, Simmons Cancer Institute
Springfield, Illinois, United States, 62794
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
New York, New York, United States, 10032
The West Clinic
Memphis, Tennessee, United States, 38120
Nashville, Tennessee, United States, 37232
View full eligibility
Tris trial is registered with FDA with number: NCT01459159. The sponsor of the trial is Telik and it is looking for 162 volunteers for the current phase.
Official trial title: Phase 2b Study of Oral Ezatiostat Hydrochloride (Telintra®) in Patients With Low to Intermediate-1 Risk, Non-Deletion 5q Myelodysplastic Syndrome
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