Study of Ezatiostat (Telintra Tablets) for Treatment of Severe Chronic Neutropenia
This study has been terminated.
(Study TLK199.2103 was terminated for business reasons.)
Sponsor:
Telik
Information provided by (Responsible Party):
Telik
ClinicalTrials.gov Identifier:
NCT00909584
First received: May 26, 2009
Last updated: November 20, 2013
Last verified: November 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Severe Chronic Neutropenia |
Drug: Ezatiostat Hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia |
Resource links provided by NLM:
Further study details as provided by Telik:
Primary Outcome Measures:
- Objective absolute neutrophil count (ANC) response rate [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of infections, oropharyngeal ulcers and antibiotic use [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
- Incidence and duration of hospitalizations [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
- FACT-N quality of life assessment [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
- Safety assessments [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
| Enrollment: | 9 |
| Study Start Date: | April 2009 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
4-Week dose equilibration period with Telintra followed by 4 month treatment period
|
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:
|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909584
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909584
Locations
| 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 | |
Sponsors and Collaborators
Telik
Investigators
| Study Director: | Gail Brown, MD | Telik |
More Information
| Responsible Party: | Telik |
| ClinicalTrials.gov Identifier: | NCT00909584 History of Changes |
| Other Study ID Numbers: | TLK199.2103 |
| Study First Received: | May 26, 2009 |
| Last Updated: | November 20, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Telik:
|
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 |
Additional relevant MeSH terms:
|
Neutropenia Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases |
ClinicalTrials.gov processed this record on September 29, 2016