RecruitingPhase 2NCT05873712

Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome

A Phase II Study Evaluating the Safety and Efficacy of the Combination of Zanubrutinib Plus Lisocabtagene Maraleucel for Richter's Syndrome


Sponsor

Aseel Alsouqi

Enrollment

24 participants

Start Date

Jul 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well zanubrutinib and lisocabtagene maraleucel (liso-cel) work together in treating patients with Richter's syndrome that has come back (recurrent) or does not respond to treatment (refractory). Richter's syndrome occurs when chronic lymphocytic leukemia and/or small lymphocytic leukemia transforms into an aggressive lymphoma, which is a cancer of the lymph nodes. Zanubrutinib is a class of medication called a kinase inhibitor. These drugs work by preventing the action of abnormal proteins that tell cancer cells to multiply, which helps stop the spread of cancer. Liso-cel is a type of treatment known as chimeric antigen receptor (CAR) T cell therapy. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving zanubrutinib and liso-cell together may kill more cancer cells in patients with recurrent or refractory Richter's syndrome.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two treatments — zanubrutinib (a targeted oral drug for B-cell cancers) and lisocabtagene maraleucel (a CAR-T cell therapy that uses engineered immune cells) — for people with Richter's Syndrome, a rare and aggressive transformation of chronic lymphocytic leukaemia (CLL) into a large B-cell lymphoma. **You may be eligible if...** - You have been diagnosed with Richter's Syndrome (CLL that has transformed into diffuse large B-cell lymphoma) - You have had at least one prior treatment for CLL or the transformed lymphoma - You are 18 or older - Your overall health is adequate (ECOG 0–2) **You may NOT be eligible if...** - You have never had prior treatment for CLL or lymphoma - You have active central nervous system involvement (brain or spinal cord) - You have significant heart problems or organ dysfunction - You have certain uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREBone Marrow Biopsy

Undergo BM biopsy

PROCEDUREComputed Tomography

Undergo CT and/or PET/CT

DRUGCyclophosphamide

Given IV

DRUGFludarabine

Given IV

PROCEDURELeukapheresis

Given IV

BIOLOGICALLisocabtagene Maraleucel

Given IV

PROCEDURELymph Node Biopsy

Undergo lymph node biopsy

PROCEDUREPositron Emission Tomography

Undergo PET/CT

DRUGZanubrutinib

Given PO


Locations(3)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT05873712


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