Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
- Registration Number
- NCT00909584
- Lead Sponsor
- Telik
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Ezatiostat Hydrochloride 4-Week dose equilibration period with Telintra followed by 4 month treatment period
- Primary Outcome Measures
Name Time Method Objective absolute neutrophil count (ANC) response rate 18 Months
- Secondary Outcome Measures
Name Time Method FACT-N quality of life assessment 18 Months Safety assessments 18 Months Incidence of infections, oropharyngeal ulcers and antibiotic use 18 Months Incidence and duration of hospitalizations 18 Months
Trial Locations
- Locations (4)
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Cancer Care Centers of South Texas
🇺🇸San Antonio, Texas, United States