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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00909584

Enrollment

Registered

2009-05-28

Start date

2009-04-30

Completion date

2013-05-31

Last updated

2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Chronic Neutropenia

Keywords

Hematology, Neutropenia, SCN, Severe Chronic Neutropenia, Idiopathic, Telintra, ezatiostat hydrochloride, ezatiostat, TLK199, Glutathione, Glutathione analog, Glutathione Transferase, Glutathione Transferase inhibitor, Glutathione Transferase P1-1 inhibitor, GSTp1-1 inhibitor, Apoptosis, Differentiation, Enzyme inhibitor

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 observation period with an option to crossover to Telintra treatment in a 1:1 allocation.

Interventions

DRUGEzatiostat 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Objective absolute neutrophil count (ANC) response rate	18 Months

Secondary

Measure	Time frame
Incidence of infections, oropharyngeal ulcers and antibiotic use	18 Months
Incidence and duration of hospitalizations	18 Months
FACT-N quality of life assessment	18 Months
Safety assessments	18 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026