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Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia

NCT ID: NCT00909584

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

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2013-05-31

Brief Summary

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This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.

Detailed Description

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Conditions

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Severe Chronic Neutropenia

Keywords

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Hematology Neutropenia SCN Severe Chronic Neutropenia Idiopathic Telintra ezatiostat hydrochloride ezatiostat TLK199 Glutathione Glutathione analog Glutathione Transferase Glutathione Transferase inhibitor Glutathione Transferase P1-1 inhibitor GSTp1-1 inhibitor Apoptosis Differentiation Enzyme inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

4-Week dose equilibration period with Telintra followed by 4 month treatment period

Group Type EXPERIMENTAL

Ezatiostat Hydrochloride

Intervention Type DRUG

Starting Dose 2000 mg orally per day in two divided doses with dose to increase or decrease to achieve target median ANC (Range 1,500-10,000 cells/uL)

2

4 Month observation period with standard of care treatment and option to crossover to Telintra treatment for 4 week dose equilibration followed by 4 week treatment period

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ezatiostat Hydrochloride

Starting Dose 2000 mg orally per day in two divided doses with dose to increase or decrease to achieve target median ANC (Range 1,500-10,000 cells/uL)

Intervention Type DRUG

Other Intervention Names

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Telintra tablets TLK199 Tablets

Eligibility Criteria

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Inclusion Criteria

* Confirmed Idiopathic Severe Chronic Neutropenia
* ECOG performance status of 0-2
* Adequate liver and renal function
* Adequate Red Blood Cell and Platelet counts

Exclusion Criteria

* Prior treatment of SCN
* Non-Idiopathic types of SCN, ie. cyclic, congenital
* History of chromosomal abnormalities, myelodysplasia, hematologic malignancy, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis (Felty's syndrome), or other collagen diseases, and drug-induced neutropenia, autoimmune neutropenia
* Use of granulocyte colony stimulating factors (G-CSF), glucocorticoids, gamma globulin, lithium or investigational drug(s) within one month of enrollment
* History of bone marrow transplantation or stem cell support
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 Brown, MD

Role: STUDY_DIRECTOR

Telik

Locations

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Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Site Status

University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status

Cancer Care Centers of South Texas

San Antonio, Texas, United States

Site Status

University of Washington Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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TLK199.2103

Identifier Type: -

Identifier Source: org_study_id