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TerminatedNCT00909584Updated Nov 25, 2013

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

A Phase 2 interventional study of Ezatiostat Hydrochloride in Severe Chronic Neutropenia, sponsored by Telik. Terminated at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-25.

Sponsored by Telik · Phase 2, Interventional, and Treatment

Why this study was terminated
Study TLK199.2103 was terminated for business reasons.
Phase
Phase 2
Study type
Interventional
Enrollment
9
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Severe Chronic Neutropenia

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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
03

In context

Neutropenia

396 studies on the registry are indexed under Neutropenia; 57 are open to participants now.

This study's enrollment of 9 is below the median of 93 across 276 interventional studies indexed under Neutropenia.

Browse Neutropenia studies →

Lead sponsor

Telik is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    1

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

    Drug: Ezatiostat Hydrochloride

  • No intervention
    2

    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

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)

    Also known as: Telintra tablets, TLK199 Tablets

06

What researchers measure

Primary outcomes

  1. Objective absolute neutrophil count (ANC) response rate

    Time frame: 18 Months

Secondary outcomes

  1. Incidence of infections, oropharyngeal ulcers and antibiotic use

    Time frame: 18 Months

  2. Incidence and duration of hospitalizations

    Time frame: 18 Months

  3. FACT-N quality of life assessment

    Time frame: 18 Months

  4. Safety assessments

    Time frame: 18 Months

07

Study locations

4 sites
  • Center for Cancer and Blood Disorders
    Bethesda, Maryland 20817, United States
  • University of Michigan Hospital
    Ann Arbor, Michigan 48109-0238, United States
  • Cancer Care Centers of South Texas
    San Antonio, Texas 78229, United States
  • University of Washington Medical Center
    Seattle, Washington 98195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00909584
Lead sponsor
Telik
Responsible party
Sponsor
First posted
May 28, 2009
Start date
Apr 2009
Primary completion
May 2013
Completion
May 2013
Last update
Nov 25, 2013

Study contacts

Gail Brown, MD
study director · Telik

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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