A Phase II Study of Combination Epcoritamab-Lenalidomide in Patients With Refractory/Relapsed Immunodeficiency-Related Large B-Cell Lymphoma
Reem Karmali
Summary
This phase II trial tests how well the combination of epcoritamab and lenalidomide work in treating patients with immunodeficiency-related large B-cell lymphoma that does not respond to treatment (refractory) or that has come back after a period of improvement (relapsed). Epcoritamab is an immunotherapy that engages T-cells in the immune system to help redirect their killing effects against lymphoma cells. Lenalidomide can modulate the immune system to enhance killing effects of lymphoma by the immune system as well. Giving patients a combination of epcoritamab and lenalidomide may work better in treating refractory or relapsed immunodeficiency-related large B-cell lymphoma.
Description
PRIMARY OBJECTIVE: I. To evaluate the six-month best response of complete response (CR) rate for the combination of epcoritamab-lenalidomide in chemotherapy ineligible patients with primary refractory or relapsed immunodeficiency-related large B-cell lymphoma. SECONDARY OBJECTIVES: I. To evaluate the objective response rate (ORR), partial response (PR) and CR rates at 3 (cycle \[C\] 4 day \[D\]1), 6 (C7D1), 12 (30 days post C12), 18 and 24 months for patients on combination epcoritamab-lenalidomide. II. To assess duration of response (DoR) at 6 (C7D1),12 (30 days post D12), 18 and 24 month…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have a pathologically confirmed diagnosis of immunodeficiency-related large B-cell lymphoma as defined by the 5th Edition of the World Health Organization (WHO) Classification of Hematolymphoid Tumors 2022 in addition to any of the following: * Lymphomas arising in immune deficiency which encompass monomorphic post-transplant lymphoproliferative disorder (PTLD) OR * Polymorphic B-cell lymphoproliferative disorder arising in the setting of immunodeficiency and/or immune dysregulation as seen in 1 or more of the following settings: * Underlying autoimm…
Interventions
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureComputed Tomography
Undergo PET/CT
- BiologicalEpcoritamab
Given SC
- DrugLenalidomide
Given PO
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePositron Emission Tomography
Undergo PET/CT
Location
- Northwestern UniversityChicago, Illinois