Phase 3
Completed N=758
PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
Source: ClinicalTrials.gov NCT00332202 ↗Enrolled (actual)
758
Serious AEs
27.9%
Results posted
Sep 2018
Primary outcomePrimary: Overall Disease-Free Survival — 42.8; 43.1 Month — p=0.541
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Disease-Free Survival |
42.8; 43.1 | 0.541 |
| SECONDARY Disease Free Survival at 2 Years |
0.785; 0.748 | — |
| SECONDARY Event-Free Survival |
0.03; 0.03; 76.81; 71.56 | — |
| SECONDARY Event-Free Survival at 2 Years |
0.781; 0.734 | — |
| SECONDARY Overall Survival |
0.03; 0.03; 76.81; 80.30 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events |
459; 230 | — |
| SECONDARY Quality of Life: Change From Baseline in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) Score |
2.45; 1.86; 2.56; 2.51; 2.04; 2.82 | 0.606 |
| SECONDARY Change From Baseline in EuroQol-5D (EQ-5D) Score |
0.02; 0.00; 0.02; 0.03; 0.03; 0.03 | 0.267 |
| SECONDARY Translational Research: DFS Participants With Diffuse Large B-cell Lymphoma (DLBCL) Germinal-center B-cells (GCB) Versus Non-germinal-center B-cells |
76.31; 75.97; 66.21; 68.20 | 0.400 |
| SECONDARY Translational Research: DFS of Participants With Diffuse Large B-cell Lymphoma (DLBCL) Protein Kinase C-β2 (PKC-β2) Expression |
64.86; 81.16; 61.54; 70.58 | 0.084 |
| SECONDARY Pharmacokinetics: Average Steady-State Concentration (Cavg,ss) for Total Analyte |
2370 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00332202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.