Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients With Relapsed/Refractory Large B-Cell Lymphoma
SWOG Cancer Research Network
Summary
This phase 2 trial studies the side effects and best dose of tazemetostat and zanubrutinib in combination with tafasitamab and lenalidomide, and to see how well these combinations work in treating patients with large B-cell lymphoma that returned or did not respond to earlier treatment. Tazemetostat is in a class of medications called EZH2 inhibitors. It helps to stop the spread of cancer cells. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. The addition of tazemetostat or zanubrutinib to tafasitamab and lenalidomide may be able to shrink the cancer or extend the time without cancer symptoms coming back.
Description
PRIMARY OBJECTIVES: I. To determine the recommended phase II dose of tafasitamab + lenalidomide + tazemetostat AND of tafasitamab + lenalidomide + zanubrutinib. (Safety Run-in) II. To compare progression-free survival (PFS) of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) treated with tafasitamab + lenalidomide + tazemetostat vs control (tafasitamab + lenalidomide) AND treated with tafasitamab + lenalidomide + zanubrutinib versus (vs) control. (Randomized Phase II Study) SECONDARY OBJECTIVES: I. To estimate the hazard ratio for PFS for control vs. tafasitamab + lenalido…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have: * Histologically confirmed relapsed/refractory LBCL as outlined by the World Health Organization (WHO) guidelines * Follicular lymphoma, grade 3B * Transformed lymphoma * High grade B-cell lymphoma with or without MYC, BCL2 and/or BCL6 rearrangements * Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanc…
Interventions
- ProcedureBiospecimen Collection
Undergo optional collection of blood
- ProcedureComputed Tomography
Undergo PET/CT and CT
- DrugLenalidomide
Given PO
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePositron Emission Tomography
Undergo PET/CT
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Locations (104)
- Banner University Medical Center - TucsonTucson, Arizona
- University of Arizona Cancer Center-North CampusTucson, Arizona
- Tower Cancer Research FoundationBeverly Hills, California
- City of Hope Comprehensive Cancer CenterDuarte, California
- City of Hope SeacliffHuntington Beach, California
- City of Hope Antelope ValleyLancaster, California