A Study for Patients With Non-Hodgkin's Lymphomas
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | November 2007 |
| End Date: | February 27, 2018 |
A Multicenter, Open-label, Noncomparative Study of Enzastaurin in Patients With Non-Hodgkin's Lymphomas
In this study, all patients will get investigational drug. There will be no comparator drug.
This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and
Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes:
- T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL)
- Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2)
and marginal zone lymphoma
- Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and
aggressive lymphoma with prior clinical history of indolent lymphoma.
This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and
Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes:
- T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL)
- Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2)
and marginal zone lymphoma
- Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and
aggressive lymphoma with prior clinical history of indolent lymphoma.
Inclusion Criteria:
- Have measurable lesions
- Have recovered from prior chemotherapies
- Have an estimated life expectancy of at least 12 weeks
- Hepatic: total bilirubin less than or equal to 1.5 XULN; ATL/AST less than or equal to
2.0 x ULN (less than 5x if liver metastases are present)
- Renal: serum creatinine less than or equal to 1.5XULN
- Adequate bone marrow reserve: platelets greater than or equal to 75 x 109 /L, absolute
neutrophil count (ANC) greater than or equal to 1.0 x 09 /L
Exclusion Criteria:
- Have a second primary malignancy (except adequately treated nonmelanomatous skin
cancer, or other cancer that is considered cured by surgical resection or radiation).
- Anti-lymphoma therapy within the past 3 weeks
- Unable to swallow tablets
- Unable to discontinue use of carbamazepine, phenobarbital and phenytoin at least 14
days prior to study enrollment
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