Study on Epcoritamab as a Follow-Up Treatment for CLL/SLL

Sponsor: Zulfa Omer

Sponsor score: 0

ClinicalTrials ID:NCT07108998

Provider View

This phase 2 clinical trial is testing the use of Epcoritamab as a follow-up treatment for patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have already been treated with certain medications.

Patient Parameters

Program Overview

The study aims to find out if using Epcoritamab after treatment with acalabrutinib or zanubrutinib, with or without obinutuzumab, can help patients with CLL or SLL achieve a deeper response and possibly stop treatment while maintaining remission. Patients will receive up to 12 cycles of Epcoritamab while continuing their current treatment. The study will monitor how well the cancer responds and whether the treatment can lead to a long-lasting remission.

Description

This phase II study involves multiple centers and is designed to test if Epcoritamab can help patients with CLL or SLL achieve a complete response after being treated with acalabrutinib or zanubrutinib, with or without obinutuzumab, for at least 12 months. The goal is to see if this approach can lead to a deep remission, allowing patients to stop treatment while maintaining their health. The study will start with a safety phase for the first 9 patients, followed by a two-stage design to evaluate the treatment's effectiveness. Eligible patients will receive Epcoritamab injections for 12 cycles while continuing their current treatment. The response to treatment will be assessed through blood tests, imaging, and bone marrow biopsies. Patients who complete the 12 cycles can continue their current treatment based on discussions with their doctor, regardless of their response status.

Eligibility Criteria

Exclusion Criteria

  • Achieved a complete or partial response with no detectable disease in blood or bone marrow after treatment with acalabrutinib or zanubrutinib, with or without obinutuzumab.
  • No CD20 marker on CLL cells before treatment.
  • Have not received prior treatment with a specific type of antibody.
  • Organ transplant recipients are excluded unless they have no active graft versus host disease requiring treatment within the past year.
  • No live vaccines within 28 days before starting the study treatment.
  • No autoimmune diseases requiring high doses of immunosuppressive drugs.
  • No central nervous system diseases that would prevent participation.
  • No known allergies to the treatment drugs.
  • No active Richter's transformation, except for certain conditions like accelerated phase or prolymphocytic progression.
  • No recent radiation therapy unless deemed safe by the investigator.
  • No need for blood thinners like warfarin.
  • No major surgery within 14 days before starting the study drug.
  • No significant heart disease or recent heart attack.
  • Not pregnant, planning to become pregnant, or breastfeeding.
  • No uncontrolled infections or other significant health conditions.
  • No poorly controlled HIV or active hepatitis B or C infections.
  • No unexplained fever above 38.3°C within 7 days before starting the study drug.
  • No other cancers that could interfere with the study.

Locations

FACILITYZIPCITYSTATE
University of Cincinnati45219CincinnatiOhio

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