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

This study has been terminated.
(Study TLK199.2103 was terminated for business reasons.)
Sponsor:
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT00909584
First received: May 26, 2009
Last updated: November 20, 2013
Last verified: November 2013
  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:


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 ]

Enrollment: 9
Study Start Date: April 2009
Study Completion Date: May 2013
Primary Completion Date: May 2013 (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
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, see Learn About Clinical Studies.

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: November 20, 2013
Health Authority: United States: Food and Drug Administration

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:
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014