PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

May 30, 2006

Last Updated Date

April 20, 2009

Start Date ^†

June 2006

Current Primary Outcome Measures ^†

Overall disease free survival [ Time Frame: baseline to measured progressive disease ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00332202 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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 ]

Original Secondary Outcome Measures ^†

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

Descriptive Information

Brief Title ^†

PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

Official Title ^†

A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Non Hodgkin Lymphoma

Intervention ^†

Drug: enzastaurin
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

709

Estimated Completion Date

May 2017

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Location Countries ^†

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

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00332202

Responsible Party

Chief Medical Officer, Eli Lilly

Secondary IDs ^††

H6Q-MC-JCBJ, PRELUDE

Study Sponsor ^†

Eli Lilly and Company

Collaborators ^††

Investigators ^†

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

Information Provided By

Eli Lilly and Company

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.