Epcoritamab and Lenalidomide in Treating Patients With Refractory or Relapsed Immunodeficiency-Related Large B-Cell Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06723457
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Polymorphic Post-Transplant Lymphoproliferative Disorder
  • Refractory B-Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Epcoritamab — BIOLOGICAL
    Given SC
  • Lenalidomide — DRUG
    Given PO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

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.

Key Dates

Start date
Jul 25, 2025
Status verified
Feb 2026
Primary completion
Feb 18, 2027
Completion
Feb 18, 2029

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (epcoritamab, lenalidomide)
    Patients receive epcoritamab SC weekly during cycle 1 and on days 1, 8, 15, and 22 of cycles 2-3, and day 1 of cycles 4-12. Patients also receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT and collection of blood samples throughout the study and may undergo MRI during screening.

Primary Outcome Measure

Best response of complete response (CR) rate [ Time Frame: At 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-

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