Glofitamab + Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment approach for individuals newly diagnosed with a specific type of lymphoma linked to HIV. It combines glofitamab, an experimental drug, with a standard chemoimmunotherapy regimen called R-CHOP. The goal is to determine if this combination is safe and effective in combating the cancer by supporting the body's immune system. Individuals diagnosed with HIV-associated large B-cell lymphoma who are already receiving HIV treatment might be suitable candidates for this study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
Is there any evidence suggesting that glofitamab plus R-CHOP is likely to be safe for humans?
Research has shown that glofitamab, a key part of this trial, has been safe in past studies. In one study, 43% of patients achieved a complete response, meaning their cancer was no longer detectable. Some patients, however, experienced side effects such as cytokine release syndrome, which can cause fever and fatigue, and infections. Despite these side effects, the overall benefits of glofitamab outweigh the risks.
Additionally, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone form a treatment plan called R-CHOP. These drugs are well-known and have been used to treat certain types of cancer. Each drug has its own possible side effects, but they are generally considered safe when used correctly.
As this is an early-phase trial, the main goal is to assess the safety of combining glofitamab with R-CHOP. More data is needed to fully understand how well patients tolerate this combination. However, current evidence suggests it could be safe with manageable side effects.12345Why do researchers think this study treatment might be promising?
Most treatments for diffuse large B-cell lymphoma (DLBCL), like the standard R-CHOP regimen, rely on chemoimmunotherapy to target cancer cells. But Glofitamab works differently by using a novel mechanism that targets CD20 and CD3 proteins, which helps bridge cancer cells to T-cells, supercharging the body's immune response. Researchers are excited about Glofitamab because it adds a powerful immunotherapy component to the existing R-CHOP regimen, potentially improving outcomes for patients who haven't responded well to standard treatments. This combination approach aims to enhance the effectiveness of the immune system in attacking cancer cells, offering new hope for better treatment responses.
What evidence suggests that this trial's treatments could be effective for large B-cell lymphoma?
Research has shown that glofitamab, a special type of antibody, has potential in treating diffuse large B-cell lymphoma (DLBCL). In earlier studies, glofitamab helped up to 80% of patients, with some experiencing complete remission, meaning their cancer disappeared entirely. This treatment aids the immune system in finding and destroying cancer cells. In this trial, participants will receive a combination of glofitamab with the R-CHOP regimen, which includes the drug rituximab and has served as a reliable treatment for DLBCL for many years. This combination might offer a strong approach to fighting this type of lymphoma.46789
Who Is on the Research Team?
Stefan K Barta
Principal Investigator
AIDS Malignancy Consortium
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed, CD20-positive large B-cell lymphoma who are living with HIV and already taking antiretroviral therapy. Participants must have measurable cancer and be able to give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive RCHOP and glofitamab. RCHOP cycles repeat every 21 days for 6 cycles, and glofitamab cycles repeat every 21 days for 8 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Doxorubicin Hydrochloride
- Glofitamab
- Prednisone
- Rituximab
- Vincristine Sulfate
Trial Overview
The study tests the safety of adding glofitamab (an immune-targeting antibody) to standard R-CHOP chemoimmunotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) in people with HIV-associated large B-cell lymphoma.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
1.
caseseries.advancedpractitioner.com
caseseries.advancedpractitioner.com/resource-center/dlbcl/news/glofitamab-monotherapy-in-relapsed-or-refractory-large-b-cell-lymphoma-extended-follow-up-from-a-pivotal-phase-ii-study-and-subgroup-analyses-in-patients-with-prior-chimeric-antigen-receptor-t-cell-therapy-and-by-baseline-total-metabolic-tu/DLBCL Resource Center
The IRC-assessed overall and complete response (CR) rates were 52% and 40%, respectively, with the majority of CRs (65%) ongoing at data cut-off ...
2.
clinical-lymphoma-myeloma-leukemia.com
clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(23)01344-7/pdfABCL-669 Glofitamab in Relapsed Refractory Diffuse ...
refractory diffuse large B-cell lymphoma (r/r DLBCL). Objectives: In this abstract, we present three patients with r/r DLBCL who were treated with glofitamab.
3.
cancernetwork.com
cancernetwork.com/view/fda-approves-glofitamab-in-relapsed-refractory-dlbcl-and-lbclFDA Approves Glofitamab in Relapsed/Refractory DLBCL ...
Results from the phase 1/2 NP30179 analyzing glofitamab in patients with relapsed/refractory diffuse large B-cell lymphoma and large B-cell ...
EFFICACY OF GLOFITAMAB IN PRIMARY REFRACTORY ...
Data from a follow-up in a cohort of patients who were treated with glofitamab showed a median duration of complete response of 34 months. Our case post- ...
Glofitamab-Based Treatment for Diffuse Large B-Cell ...
Specifically, glofitamab has demonstrated a 46% overall response rate in patients with difficult-to-treat forms of this cancer. However, more than half of the ...
6.
ashpublications.org
ashpublications.org/blood/article/146/18/2177/546196/Real-world-outcomes-of-patients-with-aggressive-BReal-world outcomes of patients with aggressive B-cell ...
For those treated with glofitamab, an estimated 70.0% of complete responders remained in response at 6 months;
COLUMVI® (glofitamab-gxbm) Efficacy in 3L+ DLBCL Treatment
13% of patients experienced a partial response (n=17/132; 95% CI: 8%-20%). 43% of patients achieved an complete response during the clinical trial ...
8.
ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/6522/527466/The-Clinical-Efficacy-and-Safety-of-Glofitamab-inThe Clinical Efficacy and Safety of Glofitamab in Chinese ...
Glofitamab is reported to have 35% complete responses (CR) in these heavily treated patients. kine release syndrome (CRS), infection, ...
9.
oncologynewscentral.com
oncologynewscentral.com/drugs/info/fda-rejects-glofitamab-for-diffuse-large-b-cell-lymphoma-indicationFDA Rejects Glofitamab for Diffuse Large B-cell Lymphoma ...
Results from the trial showed a 41% reduction in the risk for death (hazard ratio, 0.59; 95% confidence interval, 0.40–0.89; P=.011) for ...
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