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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Severe Chronic Neutropenia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Objective absolute neutrophil count (ANC) response rate

Outcome Time Frame:

18 Months

Safety Issue:

No

Principal Investigator

Gail Brown, MD

Investigator Role:

Study Director

Investigator Affiliation:

Telik

Authority:

United States: Food and Drug Administration

Study ID:

TLK199.2103

NCT ID:

NCT00909584

Start Date:

May 2009

Completion Date:

November 2012

Related Keywords:

  • Severe Chronic Neutropenia
  • 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
  • Neutropenia

Name

Location

University of Washington Medical CenterSeattle, Washington  98195-6043
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Cancer Care Centers of South TexasSan Antonio, Texas  78229
University of Michigan HospitalAnn Arbor, Michigan  48109