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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00332202 |
This clinical research study is to investigate the prevention of relapse in patients with diffuse large B cell lymphoma (DLBCL) using enzastaurin daily.
This is a randomised trial which compares Enzastaurin to Placebo (dummy treatment), the chance of receiving Enzastaurin is 2 to 1.
Condition | Intervention | Phase |
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Non Hodgkin Lymphoma |
Drug: enzastaurin Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin |
Estimated Enrollment: | 459 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | November 2013 |
Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental |
Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years
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B: Placebo Comparator |
Drug: placebo
oral, daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 |
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 |
Responsible Party: | Eli Lilly ( Chief Medical Officer ) |
Study ID Numbers: | 9823, H6Q-MC-JCBJ, PRELUDE |
Study First Received: | May 30, 2006 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00332202 |
Health Authority: | United States: Food and Drug Administration |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |