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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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United States of America
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Alaska
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Brugge
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Brussels
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Gent
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Leuven
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Roeselare
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Giessen
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Homburg
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Kassel
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Mainz
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Muenchen
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Greece
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Athens
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Greece
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Haidari/Athens
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Hungary
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Budapest
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Miskolc
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Mumbai
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00332202