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Chemotherapy for Patients With Lymphoma

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: NCT00436280
Recruitment Status : Completed
First Posted : February 19, 2007
Last Update Posted : November 30, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE February 16, 2007
First Posted Date  ICMJE February 19, 2007
Last Update Posted Date November 30, 2012
Study Start Date  ICMJE February 2007
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Progression Free Survival after 1 year treatment [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2007)
Progression Free Survival after 1 year treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • Response [ Time Frame: baseline to measured progressive disease ]
  • Progression Free Survival after 2 and 4 years of treatment [ Time Frame: 2 years, 4 years ]
  • Overall Survival after 1, 2 and 4 years [ Time Frame: baseline to death from any cause at 1, 2, and 4 years ]
  • Event Free Survival after 1, 2 and 4 years [ Time Frame: 1 year, 2 years, 4 years ]
  • Assessment of biomarkers relevant for Enzastaurin [ Time Frame: baseline, cycles 1-4, end of study ]
  • Characterization of pharmacokinetics of enzastaurin and it's metabolites [ Time Frame: cycles 1-4 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2007)
  • Response
  • Progression Free Survival after 2 and 4 years of treatment
  • Overall Survival after 1, 2 and 4 years
  • Event Free Survival after 1, 2 and 4 years
  • Assessment of biomarkers relevant for Enzastaurin
  • Characterization of pharmacokinetics of enzastaurin and it's metabolites
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chemotherapy for Patients With Lymphoma
Official Title  ICMJE An Open-label, Single Arm, Phase 2 Study of Rituximab, Gemcitabine and Oxaliplatin Plus Enzastaurin as Treatment for Patients With Relapsed Diffuse Large B-Cell Lymphoma
Brief Summary

The primary purpose of this study is to help answer the following research questions:

  • To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help patients with Diffuse Large B-Cell Lymphoma remain free from disease and thus live longer.
  • To assess for any side effects that might be associated with enzastaurin and R-GEMOX .
  • To look at the characteristics and levels of certain genes and proteins to learn more about DLBCL and how enzastaurin works in the body.
  • To look at the level of enzastaurin in the body and how long it remains.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma, Large Cell, Diffuse
Intervention  ICMJE
  • Drug: enzastaurin
    1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
    Other Name: LY317615
  • Drug: gemcitabine
    1000 mg/m2, IV, once, every two weeks, four to eight 2 week cycles
    Other Name: LY188011, Gemzar
  • Drug: rituximab
    375 mg/m2, IV, once every 2 weeks, four to eight 2 week cycles
  • Drug: oxaliplatin
    100 mg/m2, IV, once every two weeks, four to eight 2 week cycles
Study Arms  ICMJE Experimental: A
Interventions:
  • Drug: enzastaurin
  • Drug: gemcitabine
  • Drug: rituximab
  • Drug: oxaliplatin
Publications * Not Provided

*   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
Estimated Enrollment  ICMJE
 (submitted: February 16, 2007)
61
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of DLBCL or transformed (CD20+) indolent lymphoma
  • Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or patients who have not progressed after SD obtained in 1st- or 2nd-line.
  • Measurable disease (lymph node greater than 1.5 cm)
  • Adequate organ function
  • Greater than or equal to 60 years or less than 60 (but greater than or equal to 18 years) who are not eligible for HDC and ASCT

Exclusion Criteria:

  • Prior Allogeneic transplantation
  • More than 2 prior anticancer treatment regimens
  • Pregnant or breastfeeding
  • Human-immunodeficiency-virus (HIV)associated lymphomas
  • Brain metastases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 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 France,   Germany,   Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00436280
Other Study ID Numbers  ICMJE 9819
H6Q-MC-S013 ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
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 November 2012

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