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

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ClinicalTrials.gov Identifier: NCT00332202
Recruitment Status : Completed
First Posted : June 1, 2006
Results First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.


Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Drug: enzastaurin Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 758 participants
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
Study Start Date : June 2006
Actual Primary Completion Date : April 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Overall Disease-Free Survival [ Time Frame: Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months) ]
    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.


Secondary Outcome Measures :
  1. Disease Free Survival at 2 Years [ Time Frame: Baseline to 2 Years ]
    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.

  2. Event-Free Survival [ Time Frame: Baseline to Objective PD, Start of New Therapy or Death From Any Cause (up to 76.81 months) ]
    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.

  3. Event-Free Survival at 2 Years [ Time Frame: Baseline to 2 Years ]
    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.

  4. Overall Survival [ Time Frame: Baseline to Date of Death from Any Cause (up to 80.30 months) ]
    Overall survival (OS) time is defined as the time from the date of study enrollment to the date of death from any cause.

  5. Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: First dose through 30 days post-study treatment discontinuation (up to 81.30 months) ]
    Number of participants with treatment-emergent adverse events.

  6. Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score [ Time Frame: Baseline, Month 2; Baseline, Month 4; Baseline, Month 6; Baseline, Month 12; Baseline, Month 18; Baseline, Month 24; Baseline, Month 36 ]
    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.

  7. Change From Baseline in EuroQol-5D (EQ-5D) Score [ Time Frame: Baseline, Month 6; Baseline, Month 24; Baseline, Month 33 ]
    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.

  8. Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells [ Time Frame: Baseline to 24 months (2 years) ]
    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.

  9. Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression [ Time Frame: Baseline to 94.5 months ]
    Reported are the DFS based on PKC-β2 protein expression. Immunohistochemistry (IHC) staining was performed to assess protein expression of PKC-β2 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).

  10. Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte [ Time Frame: Month 2, Month 4: Predose ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • International Prognostic Index (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
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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


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Additional Information:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00332202    
Other Study ID Numbers: 9823
H6Q-MC-JCBJ ( Other Identifier: Eli Lilly and Company )
PRELUDE ( Other Identifier: Eli Lilly and Company )
First Posted: June 1, 2006    Key Record Dates
Results First Posted: September 10, 2018
Last Update Posted: September 10, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases