Clinical trial · Interventional
PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
A Phase 3 Clinical Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
NCT00332202CI-TRIAL-00034786completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enzastaurin | Drug | Enzastaurin | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: enzastaurin
- type
- PLACEBO_COMPARATOR
- label
- B
- interventionNames
- Drug: placebo
Primary outcomes (1)
- measure
- Overall Disease-Free Survival
- timeFrame
- Baseline to Measured Progressive Disease or Death from Any Cause (up to 80.30 months)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCrump 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. PMID 27217449