Researchers are conducting phase 2 and 3 trials to investigate novel treatment combinations for patients with previously untreated or relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
In the phase 3 ESCALADE trial, researchers are studying acalabrutinib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for patients with previously untreated DLBCL.1
Another phase 3 trial is designed to evaluate epcoritamab in combination with R-CHOP for patients with previously untreated DLBCL.2
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In the phase 2 LOTIS-9 trial, researchers are studying loncastuximab tesirine in combination with rituximab for unfit or frail patients with previously untreated DLBCL.3
Additionally, the phase 2b VITALIZE trial is designed to assess DPX-Survivac and pembrolizumab, with or without low-dose cyclophosphamide, in patients with relapsed or refractory DLBCL.4
ESCALADE Trial: Acalabrutinib Plus R-CHOP
The phase 3, randomized, double-blind ESCALADE trial (ClinicalTrials.gov Identifier: NCT04529772) is designed to assess the safety and efficacy of acalabrutinib plus R-CHOP.1
The trial is recruiting patients with previously untreated, non-germinal center B-cell-like (non-GCB) DLBCL. Patients must be 18 to 70 years of age. They must have pathologically confirmed DLBCL, an ECOG performance status of 0-2, no central nervous system (CNS) involvement, and no history of bleeding disorders.
Enrolled patients are randomly assigned to receive R-CHOP with acalabrutinib or R-CHOP with a placebo. The primary endpoint is progression-free survival (PFS). Secondary endpoints include event-free survival (EFS), overall survival (OS), and complete response (CR) rate.
This trial is sponsored by Acerta Pharma BV in collaboration with AstraZeneca.
Phase 3 Trial of Epcoritamab Plus R-CHOP
Another randomized, phase 3 trial is designed to investigate the addition of subcutaneous epcoritamab to R-CHOP in patients with newly diagnosed DLBCL (ClinicalTrials.gov Identifier: NCT05578976).2 Epcoritamab is a subcutaneously administered CD3 and CD20 T-cell bispecific antibody that is targeted to kill CD20-positive B cells.3
The investigators intend to enroll approximately 900 patients at 315 sites globally. Eligible participants must have newly diagnosed, histologically confirmed, CD20-positive DLBCL. They must be 18 to 79 years of age and have an ECOG performance status of 0-2.
Enrolled patients are randomly assigned to receive epcoritamab plus R-CHOP followed by epcoritamab alone or R-CHOP followed by rituximab alone. Participants have frequent medical assessments, blood tests, and questionnaires assessing side effects.
The primary endpoint for this study is PFS. Secondary endpoints include EFS, OS, CR rate, and minimal residual disease.
This trial is sponsored by AbbVie in collaboration with Genmab.
