PRELUDE: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.

Official Title

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

Conditions

Non Hodgkin’s Lymphoma

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• overall disease free survival

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

Study Start

June 2006; Expected completion: November 2013

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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

Total Enrolment

459

Contact Details

• Garran, Australian Capital Territory, 2605, Australia; Recruiting
• Gosford, New South Wales, 2250, Australia; Recruiting
• St Leonards, New South Wales, 2065, Australia; Recruiting
• Auchenflower, Queensland, 4066, Australia; Not yet recruiting
• Chermisdie, Queensland, 4032, Australia; Not yet recruiting
• Herston, Queensland, 4029, Australia; Not yet recruiting
• Woolloongabba, Queensland, 4102, Australia; Recruiting
• Adelaide, South Australia, 5000, Australia; Not yet recruiting
• Woodville, South Australia, 5011, Australia; Not yet recruiting
• Heidelberg, Victoria, 3084, Australia; Recruiting
• Prahran, Victoria, 3181, Australia; Recruiting
• Nedlands, Western Australia, 6009, Australia; Recruiting

For more information, refer to Lilly Clinical Trials