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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00332202




Registration number
NCT00332202
Ethics application status
Date submitted
30/05/2006
Date registered
1/06/2006
Date last updated
10/09/2018

Titles & IDs
Public title
PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
Scientific title
A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
Secondary ID [1] 0 0
H6Q-MC-JCBJ
Secondary ID [2] 0 0
9823
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - enzastaurin
Treatment: Drugs - placebo

Experimental: A -

Placebo comparator: B -


Treatment: Drugs: enzastaurin
1125 mg loading dose then 500 mg, oral, daily, until disease progression or maximum of 3 years

Treatment: Drugs: placebo
oral, daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Disease-Free Survival
Timepoint [1] 0 0
Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)
Secondary outcome [1] 0 0
Disease Free Survival at 2 Years
Timepoint [1] 0 0
Baseline to 2 Years
Secondary outcome [2] 0 0
Event-Free Survival
Timepoint [2] 0 0
Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months)
Secondary outcome [3] 0 0
Event-Free Survival at 2 Years
Timepoint [3] 0 0
Baseline to 2 Years
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Baseline to Date of Death from Any Cause (up to 80.30 months)
Secondary outcome [5] 0 0
Number of Participants With Treatment-Emergent Adverse Events
Timepoint [5] 0 0
First dose through 30 days post-study treatment discontinuation (up to 81.30 months)
Secondary outcome [6] 0 0
Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score
Timepoint [6] 0 0
Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36
Secondary outcome [7] 0 0
Change From Baseline in EuroQol-5D (EQ-5D) Score
Timepoint [7] 0 0
Baseline, Month 6; Baseline, Month 24; Baseline, Month 33
Secondary outcome [8] 0 0
Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells
Timepoint [8] 0 0
Baseline to 24 months (2 years)
Secondary outcome [9] 0 0
Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-ß2 (PKC-ß2) Expression
Timepoint [9] 0 0
Baseline to 94.5 months
Secondary outcome [10] 0 0
Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte
Timepoint [10] 0 0
Month 2, Month 4: Predose

Eligibility
Key inclusion criteria
* Clinical diagnosis of diffuse large B cell lymphoma
* Recently completed R-CHOP therapy and achieved remission
* International Prognostic Index (IPI) score 3,4,5
* At least 18 years of age
* Agree to study follow-up schedule
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2013
Sample size
Target
Accrual to date
Final
758
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Garran
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Gosford
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Casuarina
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Woolloongabba
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Heidelberg
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Prahran
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Nedlands
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
0811 - Casuarina
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3181 - Prahran
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00332202
Trial related presentations / publications
Crump M, Leppa S, Fayad L, Lee JJ, Di Rocco A, Ogura M, Hagberg H, Schnell F, Rifkin R, Mackensen A, Offner F, Pinter-Brown L, Smith S, Tobinai K, Yeh SP, Hsi ED, Nguyen T, Shi P, Hahka-Kemppinen M, Thornton D, Lin B, Kahl B, Schmitz N, Savage KJ, Habermann T. Randomized, Double-Blind, Phase III Trial of Enzastaurin Versus Placebo in Patients Achieving Remission After First-Line Therapy for High-Risk Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2016 Jul 20;34(21):2484-92. doi: 10.1200/JCO.2015.65.7171. Epub 2016 May 23.
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00332202