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

NCT ID: NCT01459159

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-02-28

Brief Summary

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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).

Detailed Description

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Conditions

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Myelodysplastic Syndrome (MDS)

Keywords

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Hematology MDS Myelodysplastic Syndrome Low risk MDS Int-1 risk MDS Transfusion dependence Telintra ezatiostat ezatiostat hydrochloride TLK199 Glutathione Glutathione analog Glutathione Transferase Glutathione Transferase P1-1 inhibitor GST P1-1 inhibitor Apoptosis Differentiation Enzyme inhibitor non-del (5q) non-deletion 5q

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ezatiostat hydrochloride (Telintra®)

Three weeks of treatment with ezatiostat at 2000 mg per day in divided doses followed by a one week rest period in four-week treatment cycles.

Intervention Type DRUG

Other Intervention Names

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Telintra Telintra Tablets Oral Telintra ezatiostat ezatiostat hydrochloride oral ezatiostat

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Telik

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gail L Brown, MD

Role: STUDY_DIRECTOR

Telik

Locations

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Bay Area Cancer Research Group

Concord, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

SIU School of Medicine, Simmons Cancer Institute

Springfield, Illinois, United States

Site Status

Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Site Status

Columbia University

New York, New York, United States

Site Status

The West Clinic

Memphis, Tennessee, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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TLK199.2108

Identifier Type: -

Identifier Source: org_study_id