RecruitingPhase 2NCT05388006

Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

MC198B, Phase II Study of a Combination Therapy of Acalabrutinib, Venetoclax and Durvalumab in Patients With Richter Transformation From Chronic Lymphocytic Leukemia (CLL)


Sponsor

Mayo Clinic

Enrollment

27 participants

Start Date

Jan 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests whether acalabrutinib, venetoclax, and durvalumab work in treating patients with Richter transformation from chronic lymphocytic leukemia or small lymphocytic lymphoma. Richter transformation is a rare condition in which chronic lymphocytic leukemia or small lymphocytic lymphoma changes into a fast-growing type of lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib, venetoclax, and durvalumab may help improve survival in patients with Richter transformation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — acalabrutinib, venetoclax, and durvalumab — for people with chronic lymphocytic leukemia (CLL), a slow-growing blood cancer. These drugs work through different mechanisms: blocking cancer cell growth signals, triggering cancer cell death, and recruiting the immune system to attack the cancer. **You may be eligible if...** - You are 18 or older and willing to provide consent - You have been diagnosed with chronic lymphocytic leukemia (CLL) meeting standard criteria for treatment - You are willing to attend regular follow-up visits - Your heart, liver, and kidney function are within acceptable limits **You may NOT be eligible if...** - You have serious uncontrolled heart problems such as irregular heartbeat or heart failure - You have active, uncontrolled infections - You are on blood-thinning medications that cannot be safely managed during the study - You are pregnant or breastfeeding 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

DRUGAcalabrutinib

Given PO

BIOLOGICALDurvalumab

Given IV

DRUGVenetoclax

Given PO

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREPositron Emission Tomography (PET)

Undergo PET/CT

PROCEDUREComputed Tomography

Undergo PET/CT or CT


Locations(3)

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

View Full Details on ClinicalTrials.gov

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NCT05388006


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