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

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Telik

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