PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00332202

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 III

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:

MedlinePlus related topics: Lymphoma

Drug Information available for: Enzastaurin

U.S. FDA Resources

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
Estimated Study Completion Date:	May 2017
Estimated 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

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:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00332202 History of Changes
Other Study ID Numbers:	9823, H6Q-MC-JCBJ, PRELUDE
Study First Received:	May 30, 2006
Last Updated:	March 18, 2011
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 February 09, 2012