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

NCT00332202 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 758

Last updated 2018-09-10

Study results available
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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.

Conditions

  • Non Hodgkin Lymphoma

Interventions

DRUG

enzastaurin

1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years

DRUG

placebo

oral, daily

Sponsors & Collaborators

Principal Investigators

  • 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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2013-04-30
Completion
2013-07-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • Puerto Rico
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00332202 on ClinicalTrials.gov