Phase 2 Study of Adding Tazemetostat or Zanubrutinib to Tafasitamab and Lenalidomide for Adults with Relapsed or Refractory Large B-Cell Lymphoma Not Eligible for Transplant

What this Trial Is About

Researchers are evaluating the safety, optimal dosing, and effectiveness of combining tazemetostat or zanubrutinib with tafasitamab and lenalidomide in patients with large B-cell lymphoma that has come back or did not respond to previous treatments. This phase 2 trial aims to compare how these combinations affect progression-free survival and to study patient-reported symptoms and quality of life. The study also explores differences based on molecular and genetic subtypes of lymphoma, with additional objectives including banking specimens for future research. The trial includes a dose-escalation safety run-in phase where patients receive either tafasitamab plus lenalidomide with tazemetostat or with zanubrutinib. After this, patients enter a randomized phase where they receive one of three treatments tafasitamab with lenalidomide and tazemetostat, tafasitamab with lenalidomide alone, or tafasitamab with lenalidomide and zanubrutinib. Treatments involve intravenous tafasitamab and oral lenalidomide, tazemetostat, or zanubrutinib. Patients undergo PETCT, CT, or MRI scans throughout the trial, and may optionally provide blood samples. Participants will be monitored regularly with imaging scans to assess their cancer and treatment response. They will complete questionnaires about lymphoma symptoms, side effects, and quality of life at baseline and during follow-up. Blood samples may be collected for research. The main outcome measured is progression-free survival up to three years after randomization. The study also tracks adverse events, overall survival, and patient-reported outcomes over time. Participation length varies but includes treatment and follow-up assessments.

Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment