Overview

This trial is active, not recruiting.

Conditions t-cell lymphoma, b-cell lymphoma
Treatment enzastaurin
Phase phase 2
Sponsor Eli Lilly and Company
Start date November 2007
End date March 2010
Trial size 64 participants
Trial identifier NCT00542919, 11503, H6Q-MC-S057

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Indolent B-Cell
enzastaurin LY317615
1125 mg loading dose then 500 mg, oral, daily until progressive disease
(Experimental)
Aggressive B-Cell
enzastaurin LY317615
1125 mg loading dose then 500 mg, oral, daily until progressive disease
(Experimental)
T-Cell
enzastaurin LY317615
1125 mg loading dose then 500 mg, oral, daily until progressive disease

Primary Outcomes

Measure
Tumor response rate
time frame: baseline to measured progressive disease

Secondary Outcomes

Measure
Progression-free survival
time frame: baseline to measured progressive disease
Time to progressive disease
time frame: baseline to measured progressive disease
Duration of response
time frame: time of response to progressive disease
Progression free survival
time frame: 1 Year
Safety
time frame: every cycle

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Multicenter, Open-label, Noncomparative Study of Enzastaurin in Patients With Non-Hodgkin's Lymphomas
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.