NCT04824092

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

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 899 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Tafasitamab	Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Lenalidomide	Lenalidomide PO will be administered as per the schedule specified in the respective arm.
DRUG	Rituximab	Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Cyclophosphamide	Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Doxorubicin	Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Vincristine	Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Prednisone	Prednisone PO will be administered as per the schedule specified in the respective arm.
DRUG	Tafasitamab placebo	0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Lenalidomide placebo	Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2021-05-11
• Primary completion: 2026-09-01
• Completion: 2027-11-01
• First posted: 2021-04-01
• Last updated: 2026-04-01

Locations

307 sites across 29 countries: United States, Argentina, Australia, Austria, Canada, Colombia, Czechia, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Malaysia, New Zealand, Philippines, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study