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

Telik

Status and phase: Terminated; Phase 2

Conditions: Severe Chronic Neutropenia

Treatments: Drug: Ezatiostat Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909584

TLK199.2103

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

1

Experimental group

Description:

4-Week dose equilibration period with Telintra followed by 4 month treatment period

Treatment:

Drug: Ezatiostat Hydrochloride

2

No Intervention group

Description:

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