Text Size

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Telik.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT00909584
First received: May 26, 2009
Last updated: October 17, 2012
Last verified: February 2010
History of Changes
  Purpose

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 Intervention Phase
Severe Chronic Neutropenia
 Drug: Ezatiostat Hydrochloride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Telik:

Primary Outcome Measures:
  • Objective absolute neutrophil count (ANC) response rate [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of infections, oropharyngeal ulcers and antibiotic use [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • Incidence and duration of hospitalizations [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • FACT-N quality of life assessment [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • Safety assessments [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • ezatiostat hydrochloride
  • 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909584

Locations
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
Study Director: Gail Brown, MD Telik
  More Information

No publications provided

Responsible Party: Telik
ClinicalTrials.gov Identifier: NCT00909584     History of Changes
Other Study ID Numbers: TLK199.2103
Study First Received: May 26, 2009
Last Updated: October 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Telik:
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

Additional relevant MeSH terms:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013