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Study TLK199.2103 was terminated for business reasons.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 4-Week dose equilibration period with Telintra followed by 4 month treatment period |
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| 2 | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezatiostat Hydrochloride | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective absolute neutrophil count (ANC) response rate | 18 Months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Brown, MD | Telik | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Cancer and Blood Disorders | Bethesda | Maryland | 20817 | United States | ||
| University of Michigan Hospital |
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| ID | Term |
|---|---|
| C535815 | Neutropenia, severe chronic |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| C096329 | gamma-Glu-S-BzCys-PhGly diethyl ester |
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|
| 18 Months |
| Safety assessments | 18 Months |
| 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 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |