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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
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Secondary ID [1]
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H6Q-MC-JCBJ
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Secondary ID [2]
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9823
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non Hodgkin Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Disease-Free Survival
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Assessment method [1]
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Overall Disease-Free Survival (DFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease) or death from any cause. DFS was assessed according to International Working Group recommendations. Progressive disease (PD) is defined as a = 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.
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Timepoint [1]
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Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)
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Secondary outcome [1]
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Disease Free Survival at 2 Years
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Assessment method [1]
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Disease-free survival at 2 years (DFS2) is defined as the rate of DFS at 2 years from the date of study enrollment and is determined using the distribution of overall DFS times. Disease-free survival rates at 2 years will be estimated using the Kaplan-Meier method.
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Timepoint [1]
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Baseline to 2 Years
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Secondary outcome [2]
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Event-Free Survival
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Assessment method [2]
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Overall Event-Free Survival (EFS) time is defined as the time from the date of study enrollment to the first date of objectively determined disease recurrence (progressive disease), institution of a new anti-cancer treatment, or death from any cause. Progressive disease (PD) is defined as a = 50% increase from the lowest point in the sum of the product of the diameters (SPD) of any previously identified abnormal node for partial or nonresponders, or the appearance of any new lesion during or at the end of therapy.
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Timepoint [2]
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Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months)
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Secondary outcome [3]
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Event-Free Survival at 2 Years
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Assessment method [3]
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Event-Free Survival at 2 years (EFS2) is defined as the rate of EFS at 2 years from the date of study enrollment and is determined using the distribution of overall EFS times. Event-free survival rates at 2 years will be estimated using the Kaplan-Meier method.
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Timepoint [3]
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Baseline to 2 Years
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Secondary outcome [4]
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Overall Survival
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Assessment method [4]
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Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause.
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Timepoint [4]
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Baseline to Date of Death from Any Cause (up to 80.30 months)
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Secondary outcome [5]
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Number of Participants With Treatment-Emergent Adverse Events
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Assessment method [5]
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Number of participants with treatment-emergent adverse events.
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Timepoint [5]
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First dose through 30 days post-study treatment discontinuation (up to 81.30 months)
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Secondary outcome [6]
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Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score
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Assessment method [6]
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The FACT-Lym assesses health-related quality of life (HRQoL) in participants with non-Hodgkin lymphoma. It includes the 27-item cancer-specific FACT-G (General), which assesses physical, social/family, emotional and functional well-being, plus a 15-item subscale that assesses concerns specific to lymphoma. Each item is scored on a scale from 0 (not at all) to 4 (very much), yielding a possible score of 0-168, with higher scores representing better HRQoL. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline adjusting for baseline covariates.
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Timepoint [6]
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Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36
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Secondary outcome [7]
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Change From Baseline in EuroQol-5D (EQ-5D) Score
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Assessment method [7]
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The EQ-5D instrument is a participant-rated questionnaire used to evaluate health status. The EQ-5D assesses five dimensions (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) that participants rate using three levels (no problem, some problem, or extreme problem), as well as overall health status. The five dimensions can be combined using country-specific weights to create an estimate of overall health status score. The possible values for score range from -0.594 (severe problems in all 5 dimensions) to 1 (no problem in all dimensions) on a scale where 1 represents the best possible health state. This analysis utilized mixed-effect model repeated measure (MMRM) analysis of change from baseline in the EQ-5D for the United Kingdom population-based index score adjusting for baseline covariates.
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Timepoint [7]
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Baseline, Month 6; Baseline, Month 24; Baseline, Month 33
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Secondary outcome [8]
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Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells
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Assessment method [8]
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Reported are the DFS for GCB and non-GCB status. DLBCL molecular subtypes of GCB/non-GCB using Hans' algorithm were determined by protein expression by immunohistochemistry (IHC) staining was used to assess molecular subtype characterization of GCB and non-GCB.
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Timepoint [8]
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Baseline to 24 months (2 years)
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Secondary outcome [9]
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Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-ß2 (PKC-ß2) Expression
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Assessment method [9]
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Reported are the DFS based on PKC-ß2 protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-ß2 in cytoplasm scored for percent of tumor cells stained, and using 50% positive staining as the cutoff for high/low expression (high expression: >=50% staining, low expression: <50% staining).
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Timepoint [9]
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Baseline to 94.5 months
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Secondary outcome [10]
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Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte
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Assessment method [10]
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Timepoint [10]
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Month 2, Month 4: Predose
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2013
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Sample size
Target
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Accrual to date
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Final
758
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,VIC,WA
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Recruitment hospital [1]
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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
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Recruitment hospital [2]
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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
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Recruitment hospital [3]
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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
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Recruitment hospital [4]
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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
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Recruitment hospital [5]
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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
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Recruitment hospital [6]
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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
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Recruitment hospital [7]
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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
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2250 - Gosford
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Recruitment postcode(s) [3]
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0811 - Casuarina
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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3181 - Prahran
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Alaska
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California
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Florida
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Indiana
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Iowa
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Massachusetts
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Missouri
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Guang Zhou
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China
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Hangzhou
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China
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Herlev
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France
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Rome
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Gunma
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Kyoto
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Mie
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Tokyo
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Korea, Republic of
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Daegu
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Korea, Republic of
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Hwasun-Gun
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Korea, Republic of
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Seoul
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Col. Florida
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San Luis Potosi
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Toluca
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Wroclaw
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Portugal
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Coimbra
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Portugal
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Hospitalet Llobregat
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Madrid
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Santander
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Toledo
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Valencia
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Sweden
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Lund
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Sweden
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Umea
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Sweden
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Uppsala
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Changhua
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Kaohsiung
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Taiwan
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Neihu Taipei
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Taichung
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Tainan
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Taipei
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United Kingdom
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Devon
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United Kingdom
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East Sussex
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United Kingdom
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Kent
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United Kingdom
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Scotland
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eli Lilly and Company
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00332202
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Public notes
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Contacts
Principal investigator
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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)
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Eli Lilly and Company
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00332202
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