RecruitingPhase 1Phase 2NCT06249191

Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma

A Phase Ib/II Study Evaluating the Safety and Efficacy of Mosunetuzumab in Combination With DA EPOCH in Previously Untreated C-Myc Rearrangement Positive High-Grade B Cell Lymphomas


Sponsor

OHSU Knight Cancer Institute

Enrollment

30 participants

Start Date

Jun 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase Ib/II clinical trial tests the safety, side effects, and effectiveness of mosunetuzumab with chemotherapy for the treatment of patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma. 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). Immunotherapy with monoclonal antibodies, such as mosunetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone work in different ways to stop the growth of cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mosunetuzumab with chemotherapy may be safe, tolerable and/or effective in treating patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding mosunetuzumab (a bispecific antibody that helps the immune system attack cancer cells) to a standard chemotherapy regimen (R-CHOP) improves outcomes for people newly diagnosed with aggressive B-cell lymphoma that has a specific genetic abnormality called c-Myc rearrangement. These "double-hit" or "triple-hit" lymphomas are particularly hard to treat. **You may be eligible if...** - You are between 18 and 75 years old - You have newly diagnosed high-grade B-cell lymphoma or diffuse large B-cell lymphoma (DLBCL) with a c-Myc rearrangement confirmed by FISH testing - You have not received any prior treatment for this cancer - Your tumor is measurable on scans - You have adequate blood counts and organ function **You may NOT be eligible if...** - You have previously been treated for this lymphoma - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active HIV, hepatitis B, or hepatitis C infection 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREBiopsy

Undergo tumor biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

PROCEDUREComputed Tomography

Undergo CT scan

DRUGCyclophosphamide

Given IV

DRUGDoxorubicin

Given IV

PROCEDUREEchocardiography

Undergo echocardiography

DRUGEtoposide

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALMosunetuzumab

Given IV

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

PROCEDUREPositron Emission Tomography

Undergo PET scan

DRUGPrednisone

Given PO

DRUGVincristine

Given IV


Locations(1)

OHSU Knight Cancer Institute

Portland, Oregon, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06249191


Related Trials