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NCT04824092Phase 3ACTIVE NOT RECRUITING

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

Study 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 / Drugs
TafasitamabLenalidomideRituximabCyclophosphamideDoxorubicinVincristinePrednisoneTafasitamab placeboLenalidomide placebo
View on ClinicalTrials.gov ↗
Sponsor
INCY
Incyte Corporation
Oncology
F35/100
Study Details
Enrollment899 participants
Primary Completion—
Lead SponsorIncyte Corporation
Data Retrieved2026-04-11 02:55:29.647267+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 899 participants
Sponsor Catalyst Profile

Incyte Corporation (INCY) is the sponsoring company for this trial. BiotechSign currently grades this company F (35/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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