OncRef

Clinical Trial: NCT04824092

Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Incyte Corporation
Information Provided By:Incyte Corporation
Last Update Posted:2026-04-01

Study Overview

Brief Summary

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to compare the efficacy and safety of the humanized monoclonal anti CD19 antibody tafasitamab plus lenalidomide in addition to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP in previously untreated, high-intermediate and high-risk patients with newly-diagnosed DLBCL

Official 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)

Conditions

Diffuse Large B-cell Lymphoma

Intervention / Treatment

  • Drug: Tafasitamab
  • Drug: Lenalidomide
  • Drug: Rituximab
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin
  • Drug: Vincristine
  • Drug: Prednisone
  • Drug: Tafasitamab placebo
  • Drug: Lenalidomide placebo

Other Study ID Numbers

  • MOR208C310
  • 2022-500237-92-00
  • 2020-002990-84

Start Date (Actual)

2021-05-11

Primary Completion Date (Estimated)

2026-09-01

Study Completion Date (Estimated)

2027-11-01

Enrollment (Actual)

899

Study Type

Interventional

Phase

Phase 3