Status:
TERMINATED
Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
Lead Sponsor:
Telik
Conditions:
Severe Chronic Neutropenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 observati...
Eligibility Criteria
Inclusion
- Confirmed Idiopathic Severe Chronic Neutropenia
- ECOG performance status of 0-2
- Adequate liver and renal function
- Adequate Red Blood Cell and Platelet counts
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00909584
Start Date
April 1 2009
End Date
May 1 2013
Last Update
November 25 2013
Active Locations (4)
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1
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
2
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109-0238
3
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78229
4
University of Washington Medical Center
Seattle, Washington, United States, 98195