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

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07649304
Phase
PHASE1
Status
Not Yet Recruiting

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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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow biopsy or aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy or aspiration
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Glofitamab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Prednisone — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

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.

Key Dates

First listed
Jun 16, 2026
Start date
Sep 11, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (RCHOP, glofitamab)
    Patients receive RCHOP consisting of: rituximab IV over 90-360 minutes, cyclophosphamide IV over 1 hour, doxorubicin IV over 3-10 minutes, and vincristine IV over 3-10 minutes on day 1 of each cycle, and prednisone PO QD on days 1-5 of each cycle. Patients also receive glofitamab IV over 2-8 hours on days 8 and 15 of cycle 2 and on day 8 of cycles thereafter. Cycles of RCHOP repeat every 21 days for 6 cycles, and cycles of glofitamab repeat every 21 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO, bone marrow biopsy or aspiration, PET/CT, and blood sample collection throughout the study. Patients may also undergo tumor tissue biopsy during screening.

Primary Outcome Measure

Ability to deliver at least 4 full cycles of glofitamab-rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (Glofit-RCHOP) (Feasibility) [ Time Frame: Up to cycle 4 (Cycles = 21 days) ]

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