Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

NCT ID: NCT00035867

Last Updated: 2008-06-03

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

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to determine the safety and efficacy of TLK199 in patients with myelodysplastic syndrome (MDS).

Detailed Description

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Conditions

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Myelodysplastic Syndromes

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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TLK199 HCl Liposomes for Injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed diagnosis of MDS
* Adequate liver and kidney function
* Ineligible for, or refusing, allogeneic bone marrow transplant
* At least 18 years of age
* Discontinuation of growth factors (e.g., G- CSF) at least 2 weeks prior to study entry

Exclusion Criteria

* Failure to recover from any prior surgery, or any major surgery within 4 weeks of study entry
* Pregnant or lactating women
* History of allergy to eggs
* Other investigational drugs within 14 days of study entry
* Chemotherapy, radiotherapy or immunotherapy within 14 days of study entry
* Concomitant steroids or hormones for the treatment of neoplasms
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Telik

INDUSTRY

Sponsor Role lead

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

The Angeles Clinic & Research Institute

Los Angeles, California, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Midwest Cancer Research Group

Skokie, Illinois, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

The Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Site Status

Texas Cancer Associates

Dallas, Texas, United States

Site Status

M.D. Anderson Cancer Center

Houston, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

References

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Raza A, Galili N, Callander N, Ochoa L, Piro L, Emanuel P, Williams S, Burris H 3rd, Faderl S, Estrov Z, Curtin P, Larson RA, Keck JG, Jones M, Meng L, Brown GL. Phase 1-2a multicenter dose-escalation study of ezatiostat hydrochloride liposomes for injection (Telintra, TLK199), a novel glutathione analog prodrug in patients with myelodysplastic syndrome. J Hematol Oncol. 2009 May 13;2:20. doi: 10.1186/1756-8722-2-20.

Reference Type DERIVED
PMID: 19439093 (View on PubMed)

Other Identifiers

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TLK199.1001

Identifier Type: -

Identifier Source: org_study_id