A Study for Patients With Non-Hodgkin’s Lymphomas

Brief Title

A Study for Patients With Non-Hodgkin's Lymphomas

Official Title

A Multicenter, Open-label, Noncomparative Study of Enzastaurin in Patients With Non-Hodgkin's Lymphomas

Brief 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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Tumor Response Rate (RR) (Percentage of Participants Exhibiting Complete Response [CR] or Complete Response Unconfirmed [CRu] or Partial Response [PR])

Secondary Outcome

 Progression Free Survival (PFS)

Condition

T-Cell Lymphoma

Intervention

enzastaurin

Study Arms / Comparison Groups

 T-Cell

Description:  T-Cell (TCL): Peripheral and cutaneous T-cell lymphoma (PTCL, CTCL). Participants received enzastaurin 1125 milligram (mg) loading dose then 500 mg, oral, daily until progressive disease or predefined criteria for discontinuation is met. Participants who progress within the first 28 days may remain on study treatment, provided that the participant is not in need of immediate treatment with another anticancer therapy. Study treatment occurs in cycles. 1 cycle = 28 days

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

57

Start Date

November 2007

Completion Date

February 27, 2018

Primary Completion Date

March 2010

Eligibility Criteria

        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 /Liter (L)
             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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), , 

Location Countries

Australia

Location Countries

Australia

NCT ID

NCT00542919

Organization ID

11503

Secondary IDs

H6Q-MC-S057

Responsible Party

Sponsor

Study Sponsor

Eli Lilly and Company

Study Sponsor

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Study Director, Eli Lilly and Company

Verification Date

September 2020