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

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