Study on Zanubrutinib and Lisocabtagene Maraleucel for Treating Richter's Syndrome

Sponsor: Adam Kittai

Sponsor score: 0

ClinicalTrials ID:NCT05873712

Provider View

This clinical trial is exploring how well the combination of zanubrutinib and lisocabtagene maraleucel (liso-cel) works in treating patients with Richter's syndrome, a condition where chronic lymphocytic leukemia turns into a more aggressive form of lymphoma.

Patient Parameters

Program Overview

This phase II study is testing the effectiveness of two treatments, zanubrutinib and lisocabtagene maraleucel (liso-cel), for patients with Richter's syndrome. Richter's syndrome happens when chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) changes into a fast-growing cancer of the lymph nodes. Zanubrutinib is a medication that blocks certain proteins that help cancer cells grow, while liso-cel is a type of CAR T-cell therapy that uses a patient's own immune cells, modified in a lab, to attack cancer cells. The study aims to see if using these treatments together can kill more cancer cells in patients with Richter's syndrome.

Description

The main goal of this study is to see how effective the combination of zanubrutinib and lisocabtagene maraleucel (liso-cel) is in treating Richter's syndrome. Researchers also want to understand the safety of this treatment and how long its effects last.

Participants will take zanubrutinib by mouth, undergo a process called leukapheresis to collect immune cells, and receive chemotherapy drugs fludarabine and cyclophosphamide through an IV. They will also receive liso-cel through an IV. Throughout the study, participants will have bone marrow and lymph node biopsies, blood tests, and imaging scans like CT, PET/CT, or MRI to monitor their condition.

After completing the study, participants will be followed for 24 months, and then every 6 months until their disease progresses or they pass away.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Richter's syndrome, which involves a type of aggressive lymphoma in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • Must have disease that has returned or not responded to previous treatments.
  • Must be 18 years or older.
  • Must have a performance status score of 0 to 2, indicating they are fully active or have some limitations but can still care for themselves.
  • Must have certain blood and organ function levels within normal ranges.
  • Must have measurable cancer that can be tracked using standard criteria.
  • Must meet all requirements for receiving CAR T-cell therapy.
  • Must be able to understand and agree to the study by signing a consent form.
  • Women of childbearing potential must agree to use effective birth control during the study and for a specified time after treatment.
  • Men must agree to use effective birth control and avoid donating sperm during the study and for a specified time after treatment.

Exclusion Criteria

  • Previous treatment with certain therapies, including CD19 directed therapy or recent stem cell transplants.
  • Active graft-versus-host disease or need for immunosuppressive drugs.
  • Inability to recover from side effects of previous treatments.
  • Difficulty swallowing or absorbing oral medications.
  • Active bleeding disorders or uncontrolled autoimmune conditions.
  • Recent gastrointestinal ulcers or significant heart disease.
  • Need for certain blood thinners or medications that affect drug metabolism.
  • Active infections like HIV or hepatitis B/C.
  • Pregnant or breastfeeding women.
  • History of autoimmune diseases requiring recent immunosuppressive treatment.
  • Recent use of live vaccines.

Locations

FACILITYZIPCITYSTATE
Ohio State University Comprehensive Cancer Center43210ColumbusOhio

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