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

Telik

Status and phase

Terminated

Phase 2

Conditions

Myelodysplastic Syndrome (MDS)

Treatments

Drug: ezatiostat hydrochloride (Telintra®)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01459159

TLK199.2108

Details and patient eligibility

About

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).

Enrollment

162 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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