RecruitingPhase 2NCT07218510

Venetoclax and Obinutuzumab Followed by Epcoritamab for the Treatment of Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, LonGEVity Trial

A Phase 2 Study of Venetoclax + Obinutuzumab Followed by Epcoritamab in Previously Untreated Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (LonGEVity)


Sponsor

City of Hope Medical Center

Enrollment

33 participants

Start Date

Jan 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial tests the effect of venetoclax and obinutuzumab followed by epcoritamab in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that have not previously received treatment. 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. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Epcoritamab, a bispecific monoclonal antibody, binds to a protein called CD3, which is found on T cells (a type of white blood cell). It also binds to a protein called CD20, which is found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. The combination of venetoclax and obinutuzumab is a standard treatment for CLL/SLL and has been found to be safe and effective. Adding epcoritamab to standard treatment with venetoclax and obinutuzumab may lead to deeper and longer-lasting responses in patients with untreated CLL/SLL.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (called LonGEVity) is testing a three-drug treatment sequence for people newly diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) — both slow-growing blood cancers. The treatment starts with venetoclax and obinutuzumab, then follows with epcoritamab, a newer type of immune-targeted therapy. **You may be eligible if...** - You are 18 or older and have been diagnosed with CLL or SLL confirmed by biopsy or flow cytometry - You have never been treated for CLL or SLL (except steroids or rituximab for immune side effects) - Your CLL or SLL is active enough to require treatment (e.g., significant weight loss, fatigue, fevers, or worsening blood counts) - You are generally well enough to tolerate treatment (ECOG score of 0 to 2) - Your cancer cells test positive for CD20 **You may NOT be eligible if...** - You have already received treatment specifically for CLL or SLL - You do not have active disease symptoms requiring treatment - Your general health status is too poor for treatment 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 blood sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspiration and biopsy

PROCEDUREBone Marrow Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDUREComputed Tomography

Undergo CT

OTHERElectronic Health Record Review

Ancillary studies

BIOLOGICALEpcoritamab

Given SC

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALObinutuzumab

Given IV

DRUGVenetoclax

Given PO


Locations(7)

City of Hope Medical Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

City of Hope at Long Beach Elm

Long Beach, California, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

City of Hope Atlanta Cancer Center

Newnan, Georgia, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT07218510


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