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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.
 
ClinicalTrials.gov Identifier: NCT00909584
Recruitment Status : Terminated (Study TLK199.2103 was terminated for business reasons.)
First Posted : May 28, 2009
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Telik

Study Description
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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

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00909584


Locations
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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
Telik
Investigators
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Study Director: Gail Brown, MD Telik
More Information
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Responsible Party: Telik
ClinicalTrials.gov 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:
Neutropenia
Severe Chronic Neutropenia
Hematology
SCN
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
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases