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

Phase 3 Completed 758 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2006-06
Primary completion: 2013-04
Completion: 2013-07

Outcome

Missed primary endpoint

registry p = 0.541; Hazard Ratio (HR) 0.92 (95% CI 0.689 to 1.216); Log Rank NCT00332202 ↗

paper Enzastaurin did not significantly improve DFS in patients with high-risk DLBCL after achieving complete response to R-CHOP. PMID 27217449 ↗

Publications

Crump 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	enzastaurin	Small molecule	500 mg	Oral