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

Primary Purpose

Severe Chronic Neutropenia

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ezatiostat Hydrochloride

About this trial

This is an interventional treatment trial for Severe Chronic Neutropenia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Cancer and Blood Disorders
University of Michigan Hospital
Cancer Care Centers of South Texas
University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Objective absolute neutrophil count (ANC) response rate

Secondary Outcome Measures

Incidence of infections, oropharyngeal ulcers and antibiotic use

Incidence and duration of hospitalizations

FACT-N quality of life assessment

Safety assessments

Full Information

NCT ID

NCT00909584

First Posted

May 26, 2009

Last Updated

November 20, 2013

Sponsor

Telik

1. Study Identification

Unique Protocol Identification Number

NCT00909584

Brief Title

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

Official Title

Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Terminated

Why Stopped

Study TLK199.2103 was terminated for business reasons.

Study Start Date

April 2009 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Telik

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Chronic Neutropenia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ezatiostat Hydrochloride

Other Intervention Name(s)

Telintra tablets, TLK199 Tablets

Intervention Description

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)

Primary Outcome Measure Information:

Title

Objective absolute neutrophil count (ANC) response rate

Time Frame

18 Months

Secondary Outcome Measure Information:

Title

Incidence of infections, oropharyngeal ulcers and antibiotic use

Time Frame

18 Months

Title

Incidence and duration of hospitalizations

Time Frame

18 Months

Title

FACT-N quality of life assessment

Time Frame

18 Months

Title

Safety assessments

Time Frame

18 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gail Brown, MD

Organizational Affiliation

Telik

Official's Role

Study Director

Facility Information:

Facility Name

Center for Cancer and Blood Disorders

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

University of Michigan Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109-0238

Country

United States

Facility Name

Cancer Care Centers of South Texas

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

University of Washington Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

12. IPD Sharing Statement

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

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