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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00332202
First received: May 30, 2006
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Non Hodgkin Lymphoma
Drug: enzastaurin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

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

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 ]

Estimated Enrollment: 709
Study Start Date: June 2006
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years
Other Name: LY317615
Placebo Comparator: B Drug: placebo
oral, daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332202

  Show 153 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

Additional Information:
No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00332202     History of Changes
Other Study ID Numbers: 9823, H6Q-MC-JCBJ, PRELUDE
Study First Received: May 30, 2006
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014