frontMIND : A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

Trial Identifiers

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• NCT04824092
• MOR208C310

Scientific Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreated, High-intermediate and High-risk Patients With Newly-diagnosed Diffuse Large B-cell Lymphoma (DLBCL)

Commercial Sponsor

MorphoSys AG

Summary

This is a randomised, double-blind trial assessing the efficacy and safety of Tafasitamab plus Lenalidomide in addition to R-CHOP, versus R-CHOP alone, is in people with previously untreated, high-intermediate, and high-risk, patients with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL). The trial has one experimental and one placebo comparator arms. Participants in the Experimental Arm will receive Tafasitamab plus lenalidomide in addition to R-CHOP for six 21-day cycles. Tafasitamab dose: 12 mg/kg body weight. Each 21-day cycle (cycles 1-6) will comprise of a tafasitamab intravenous (IV) infusion on Day 1, Day 8 and Day 15. Lenalidomide dose: 25 mg as a starting dose per os (orally) once per day on Days 1-10 of each 21-day cycle. R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle. Participants in the Placebo Comparator arm will receive Tafasitamab placebo plus lenalidomide placebo in addition to R-CHOP for six 21-day cycles. Tafasitamab placebo: 0.9% saline solution Days 1, 8 and 15 of each 21-day cycle. Lenalidomide placebo: Days 1-10 of each 21-day cycle. R-CHOP dose: Rituximab (or locally approved biosimilar) 375 mg/m2, IV Day 1 of every 21-day cycle; Cyclophosphamide 750 mg/m2, IV Day 1 of 21-day cycle; Doxorubicin 50 mg/m2, IV Day 1 of 21-day cycle; Vincristine 1.4 mg/m2 (max 2 mg) IV Day 1 of 21-day cycle; Prednisone/prednisolone 100 mg/day, per os, Day 1-5 of every 21-day cycle.