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

Stopped early · Phase 2

Conditions studied: Myelodysplastic Syndrome (MDS)

In brief

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).

Key facts

Study ID

NCT01459159

Run by

Telik

People needed

162

Starts

2011-10-01

Expected to finish

2013-02-01

Last updated by the study team

2013-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bay Area Cancer Research Group — Concord, California, United States
• University of Colorado — Aurora, Colorado, United States
• SIU School of Medicine, Simmons Cancer Institute — Springfield, Illinois, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Columbia University — New York, New York, United States
• The West Clinic — Memphis, Tennessee, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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