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A Study for Patients With Non-Hodgkin's Lymphomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00542919
Recruitment Status : Completed
First Posted : October 12, 2007
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE October 10, 2007
First Posted Date  ICMJE October 12, 2007
Last Update Posted Date April 11, 2018
Study Start Date  ICMJE November 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Tumor response rate [ Time Frame: baseline to measured progressive disease ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2007)
To evaluate the antitumor activity as measured by overall tumor response in patients with these histologically confirmed lymphomas: ~T-cell ~Indolent B-cell ~Aggressive B-cell Response will be assessed independently for each tumor subtype [ Time Frame: 2 Years ]
Change History Complete list of historical versions of study NCT00542919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2007)
  • To estimate progression-free survival for each of the subtumor populations. [ Time Frame: 2 Years ]
  • To estimate time to progression survival for each of the subtumor populations. [ Time Frame: 2 Years ]
  • To estimate duration of response for each of the subtumor populations. [ Time Frame: 2 Years ]
  • To estimate progression-free survival at one year for each of the subtumor populations. [ Time Frame: 1 Year ]
  • To evaluate the safety of enzastaurin in these patient populations [ Time Frame: 2 Years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study for Patients With Non-Hodgkin's Lymphomas
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • T-Cell Lymphoma
  • B-Cell Lymphoma
Intervention  ICMJE Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily until progressive disease
Other Name: LY317615
Study Arms  ICMJE
  • Experimental: 1
    Indolent B-Cell
    Intervention: Drug: enzastaurin
  • Experimental: 2
    Aggressive B-Cell
    Intervention: Drug: enzastaurin
  • Experimental: 3
    T-Cell
    Intervention: Drug: enzastaurin
Publications * Forsyth CJ, Gomez-Almaguer D, Camargo JF, Eliadis PE, Crespo-Solis E, Pereira J, Gutierrez-Aguirre CH, Rivas-Vera S, Roberson S, Lin B, Smith NV, Hamid O. A multicenter, open-label, noncomparative screening study of enzastaurin in adult patients with non-Hodgkin lymphomas. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):398-403. doi: 10.1016/j.clml.2013.03.005. Epub 2013 Jun 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2018)
57
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2007)
64
Actual Study Completion Date  ICMJE February 27, 2018
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Brazil,   India,   Mexico,   Peru,   United States
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT00542919
Other Study ID Numbers  ICMJE 11503
H6Q-MC-S057 ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP