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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332202
First Posted: June 1, 2006
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Disease free survival at 2 years [ Time Frame: 2 years ]
  • Event-free survival [ Time Frame: baseline to objective progression, start of new therapy or death from any cause ]
  • Event-free survival at 2 years [ Time Frame: 2 years ]
  • Overall survival [ Time Frame: baseline to date of death from any cause ]
  • Adverse events [ Time Frame: every cycle ]
  • Quality of life [ Time Frame: baseline, every other cycle until 1 year, 18 months, 24 months ]
  • Translational research [ Time Frame: baseline, cycle 2, end of study ]
  • Pharmacokinetics [ Time Frame: cycle 2, cycle 4 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00332202     History of Changes
Other Study ID Numbers: 9823
H6Q-MC-JCBJ ( Other Identifier: Eli Lilly and Company )
PRELUDE ( Other Identifier: Eli Lilly and Company )
First Submitted: May 30, 2006
First Posted: June 1, 2006
Last Update Posted: November 25, 2013
Last Verified: October 2013

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