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

Severe Chronic Neutropenia Clinical Trial

Official title:

Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00909584
• Other study ID #: TLK199.2103
• Status: Terminated
• Phase: Phase 2
• First received: May 26, 2009
• Last updated: November 20, 2013
• Start date: April 2009
• Est. completion date: May 2013

Study information

• Verified date: November 2013
• Source: Telik
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neutropenia
• Severe Chronic Neutropenia

Intervention

Drug:
• Ezatiostat Hydrochloride
Starting Dose 2000 mg orally per day in two divided doses with dose to increase or decrease to achieve target median ANC (Range 1,500-10,000 cells/uL)

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Telik

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective absolute neutrophil count (ANC) response rate		18 Months	No
Secondary	Incidence of infections, oropharyngeal ulcers and antibiotic use		18 Months	No
Secondary	Incidence and duration of hospitalizations		18 Months	No
Secondary	FACT-N quality of life assessment		18 Months	No
Secondary	Safety assessments		18 Months	No