Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2007-02-28
2012-11-30
Brief Summary
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* To assess whether Enzastaurin combined with rituximab, gemcitabine and oxaliplatin (R-GEMOX) can help participants with Diffuse Large B-Cell Lymphoma (DLBCL) 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enzastaurin + Gemcitabine Rituximab Oxaliplatin (R-GEMOX)
enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
gemcitabine
1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles
rituximab
375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles
oxaliplatin
100 mg/m², IV, once every two weeks, four to eight 2 week cycles
Interventions
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enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression or 3 years
gemcitabine
1000 mg/m², IV, once, every two weeks, four to eight 2 week cycles
rituximab
375 mg/m², IV, once every 2 weeks, four to eight 2 week cycles
oxaliplatin
100 mg/m², IV, once every two weeks, four to eight 2 week cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Relapsed/progressed after response obtained in 1st- or 2nd-line treatment, or participants who have not progressed after stable disease (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 high-dose chemotherapy high-dose chemotherapy (HDC) and autologous stem cell transplant (ASCT)
Exclusion Criteria
* More than 2 prior anticancer treatment regimens
* Pregnant or breastfeeding
* Human-immunodeficiency-virus (HIV)associated lymphomas
* Brain metastases
60 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Créteil, , France
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Dijon, , France
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Lille, , France
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Nice, , France
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Nîmes, , France
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Paris, , France
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Pessac, , France
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Pierre-Bénite, , France
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Rouen, , France
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Berlin, , Germany
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Bremen, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Kassel, , Germany
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Kiel, , Germany
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Mainz, , Germany
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Moscow, , Russia
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Saint Petersburg, , Russia
Countries
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Other Identifiers
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H6Q-MC-S013
Identifier Type: OTHER
Identifier Source: secondary_id
9819
Identifier Type: -
Identifier Source: org_study_id
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