RecruitingPhase 1Phase 2NCT05861050

Glofitamab With Obinutuzumab, Venetoclax, and Lenalidomide for the Treatment of Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma

Phase 1/2 Study of the Combination of Glofitamab, Venetoclax and Lenalidomide in Patients With Newly Diagnosed High Risk Mantle Cell Lymphoma


Sponsor

City of Hope Medical Center

Enrollment

50 participants

Start Date

Aug 10, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial tests the safety and effectiveness of glofitamab (with obinutuzumab pretreatment), venetoclax, and lenalidomide in treating patients with newly diagnosed, high risk mantle cell lymphoma. Glofitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. 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. Lenalidomide works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving venetoclax, glofitamab with obinutuzumab, and lenalidomide together may kill more cancer cells in patients with newly diagnosed, high risk mantle cell lymphoma.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of four drugs — glofitamab, obinutuzumab, venetoclax, and lenalidomide — in people who are newly diagnosed with high-risk mantle cell lymphoma, a type of blood cancer. **You may be eligible if...** - You are between 18 and 80 years old - You have been newly diagnosed with mantle cell lymphoma and have not yet received any treatment - Your lymphoma is classified as high-risk (e.g., aggressive type, high cancer-cell division rate, or specific genetic changes like TP53 mutation) - You are in reasonably good physical condition (ECOG 0–2) - Your organ function (liver, kidneys, blood) is adequate **You may NOT be eligible if...** - You have already received systemic treatment for lymphoma - You have active or uncontrolled brain involvement by the cancer - You have serious infections or other cancers - 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

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood samples

PROCEDUREBone Marrow Biopsy

Undergo bone marrow biopsy

PROCEDUREComputed Tomography

Undergo CT scan

BIOLOGICALGlofitamab

Given IV

DRUGLenalidomide

Given PO

BIOLOGICALObinutuzumab

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET scan

DRUGVenetoclax

Given PO


Locations(2)

City of Hope Medical Center

Duarte, California, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

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NCT05861050


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