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

Stopped early · Phase 2

Conditions studied: Severe Chronic Neutropenia

In brief

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.

Key facts

Study ID

NCT00909584

Run by

Telik

People needed

9

Starts

2009-04-01

Expected to finish

2013-05-01

Last updated by the study team

2013-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed Idiopathic Severe Chronic Neutropenia
• ECOG performance status of 0-2
• Adequate liver and renal function
• Adequate Red Blood Cell and Platelet counts

You may not qualify if…

• 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

Where it is running

• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• University of Michigan Hospital — Ann Arbor, Michigan, United States
• Cancer Care Centers of South Texas — San Antonio, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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