Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
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ClinicalTrials.gov Identifier: NCT00909584 |
Recruitment Status :
Terminated
(Study TLK199.2103 was terminated for business reasons.)
First Posted : May 28, 2009
Last Update Posted : November 25, 2013
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Condition or disease | Intervention/treatment | Phase |
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Severe Chronic Neutropenia | Drug: Ezatiostat Hydrochloride | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 9 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
4-Week dose equilibration period with Telintra followed by 4 month treatment period
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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)
Other Names:
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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
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- Objective absolute neutrophil count (ANC) response rate [ Time Frame: 18 Months ]
- Incidence of infections, oropharyngeal ulcers and antibiotic use [ Time Frame: 18 Months ]
- Incidence and duration of hospitalizations [ Time Frame: 18 Months ]
- FACT-N quality of life assessment [ Time Frame: 18 Months ]
- Safety assessments [ Time Frame: 18 Months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909584
United States, Maryland | |
Center for Cancer and Blood Disorders | |
Bethesda, Maryland, United States, 20817 | |
United States, Michigan | |
University of Michigan Hospital | |
Ann Arbor, Michigan, United States, 48109-0238 | |
United States, Texas | |
Cancer Care Centers of South Texas | |
San Antonio, Texas, United States, 78229 | |
United States, Washington | |
University of Washington Medical Center | |
Seattle, Washington, United States, 98195 |
Study Director: | Gail Brown, MD | Telik |
Responsible Party: | Telik |
ClinicalTrials.gov Identifier: | NCT00909584 |
Other Study ID Numbers: |
TLK199.2103 |
First Posted: | May 28, 2009 Key Record Dates |
Last Update Posted: | November 25, 2013 |
Last Verified: | November 2013 |
Neutropenia Severe Chronic Neutropenia Hematology SCN 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 Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |