RecruitingPhase 2NCT05672173

Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation

Phase 2 Study of the Combination of Lisocabtagene Maraleucel, Nivolumab, and Ibrutinib in Richter's Transformation


Sponsor

City of Hope Medical Center

Enrollment

20 participants

Start Date

Jun 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests how well adding lisocabtagene maraleucel (liso-cel) to nivolumab and ibrutinib works in treating patients with Richter's transformation. Liso-cel is in a class of medications called autologous cellular immunotherapy, a type of medication prepared by using cells from patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells and other substances that cause disease) to fight the cancer cells. Nivolumab is in a class of medications called monoclonal antibodies. It works by helping the immune system to slow or stop the grown of cancer. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Giving ibrutinib and nivolumab with Liso-cel may kill more cancer cells in patients with Richter's transformation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a three-drug combination — lisocabtagene maraleucel (liso-cel, a CAR-T therapy), nivolumab (immunotherapy), and ibrutinib (a targeted drug) — in patients with Richter's transformation, a rare and aggressive condition where chronic lymphocytic leukemia (CLL) transforms into a fast-growing large B-cell lymphoma. **You may be eligible if...** - You are 18 or older - You have been diagnosed with Richter's transformation confirmed by biopsy - Your disease is relapsed or refractory (came back or stopped responding to treatment) - Your performance status is adequate (ECOG 0–2) **You may NOT be eligible if...** - You have untreated or uncontrolled brain involvement by lymphoma - You have active autoimmune disease requiring treatment - You are pregnant or breastfeeding - You have had certain prior CAR-T therapies 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

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood specimen collection

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy and/or aspiration

PROCEDUREComputed Tomography

Undergo PET/CT

DRUGCyclophosphamide

Given IV

DRUGFludarabine

Given IV

DRUGIbrutinib

Given PO

BIOLOGICALLisocabtagene Maraleucel

Given IV

BIOLOGICALNivolumab

Given IV

PROCEDUREPheresis

Undergo apheresis

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(2)

City of Hope Medical Center

Duarte, California, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05672173


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