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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00909584
Recruitment Status : Terminated (Study TLK199.2103 was terminated for business reasons.)
First Posted : May 28, 2009
Last Update Posted : November 25, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Severe Chronic Neutropenia Drug: Ezatiostat Hydrochloride Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia
Study Start Date : April 2009
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
4-Week dose equilibration period with Telintra followed by 4 month treatment period
Drug: 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)
Other Names:
  • Telintra tablets
  • TLK199 Tablets

No Intervention: 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

Primary Outcome Measures :
  1. Objective absolute neutrophil count (ANC) response rate [ Time Frame: 18 Months ]

Secondary Outcome Measures :
  1. Incidence of infections, oropharyngeal ulcers and antibiotic use [ Time Frame: 18 Months ]
  2. Incidence and duration of hospitalizations [ Time Frame: 18 Months ]
  3. FACT-N quality of life assessment [ Time Frame: 18 Months ]
  4. Safety assessments [ Time Frame: 18 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00909584

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United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109-0238
United States, Texas
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78229
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
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Study Director: Gail Brown, MD Telik
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Responsible Party: Telik Identifier: NCT00909584    
Other Study ID Numbers: TLK199.2103
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Telik:
Severe Chronic Neutropenia
ezatiostat hydrochloride
Glutathione analog
Glutathione Transferase
Glutathione Transferase inhibitor
Glutathione Transferase P1-1 inhibitor
GSTp1-1 inhibitor
Enzyme inhibitor
Additional relevant MeSH terms:
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Leukocyte Disorders
Hematologic Diseases