AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")

Summary

This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma. Glofitamab is a bispecific monoclonal antibody, which can bind to two different antigens that are expressed by cancer cells (CD3 and CD20) at the same time. This may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving glofitamab in combination with the R-CHOP regimen may be a safe treatment for patients with newly-diagnosed with HIV-associated large B-cell lymphoma.

Conditions

• AIDS-Related Diffuse Large B-cell Lymphoma
• Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
• High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements
• High Grade B-Cell Lymphoma, Not Otherwise Specified
• Lugano Classification Stage II Adult Non-Hodgkin Lymphoma AJCC v8
• Lugano Classification Stage III Adult Non-Hodgkin Lymphoma AJCC v8
• Lugano Classification Stage IV Adult Non-Hodgkin Lymphoma AJCC v8
• Plasmablastic Lymphoma
• Primary Effusion Lymphoma

Interventions

PROCEDURE

Biopsy Procedure

Undergo tumor tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow biopsy or aspiration

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy or aspiration

PROCEDURE

Computed Tomography

Undergo PET/CT

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

BIOLOGICAL

Glofitamab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

DRUG

Prednisone

Given PO

OTHER

Questionnaire Administration

Ancillary studies

BIOLOGICAL

Rituximab

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Stefan K Barta · AIDS Malignancy Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-11

Primary Completion

2028-04-30

Completion

2028-04-30

FDA Drug

Yes