May 30, 2006 |
April 20, 2009 |
June 2006 |
Overall disease free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00332202 on ClinicalTrials.gov Archive Site |
- Disease free survival at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Event-free survival [ Time Frame: baseline to objective progression, start of new therapy or death from any cause ] [ Designated as safety issue: No ]
- Event-free survival at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: baseline to date of death from any cause ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
- Quality of life [ Time Frame: baseline, every other cycle until 1 year, 18 months, 24 months ] [ Designated as safety issue: No ]
- Translational research [ Time Frame: baseline, cycle 2, end of study ] [ Designated as safety issue: No ]
- Pharmacokinetics [ Time Frame: cycle 2, cycle 4 ] [ Designated as safety issue: No ]
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- disease free survival at 2 years
- event-free survival
- event-free survival at 2 years
- overall survival
- adverse events
- quality of life
- translational research
- pharmacokinetics
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PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin |
A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin |
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. |
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Phase III |
Interventional |
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Non Hodgkin Lymphoma |
- Drug: enzastaurin
- Drug: placebo
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Recruiting |
709 |
May 2017 |
November 2013 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Clinical diagnosis of diffuse large B cell lymphoma
- Recently completed R-CHOP therapy and achieved remission
- IPI score 3,4,5
- At least 18 years of age
- Agree to study follow-up schedule
Exclusion Criteria:
- Have received therapy other than R-CHOP for lymphoma
- Serious medical condition such as infection,second cancer,heart disease
- Received radiation to more than one lesion
- Unable to swallow tablets
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Both |
18 Years and older |
No |
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or |
1-317-615-4559 |
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United States, Australia, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Puerto Rico, Spain, Sweden, Taiwan, United Kingdom |
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NCT00332202 |
Chief Medical Officer, Eli Lilly |
H6Q-MC-JCBJ, PRELUDE |
Eli Lilly and Company |
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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 |
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Eli Lilly and Company |
April 2009 |