15 Participants NeededMy employer runs this trial

Glofitamab + Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: National Cancer Institute (NCI)
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

SK

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

I understand the study and am willing to sign a consent form.
My cancer is stage II-IV and can be measured by scans or biopsy.
Hemoglobin ≥ 8 g/dL unless due to bone marrow involvement
See 15 more

Exclusion Criteria

I am not taking medications that could interact or cause overlapping side effects.
I will stop breastfeeding if I start the study treatment.
I am able to understand the study and give my consent, or I have a legal representative to do so.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

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.

18 weeks
Multiple visits per cycle for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 2 years
Every 3 months

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

Group I: Treatment (RCHOP, glofitamab)Experimental Treatment14 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Citations

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 ...

ABCL-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.

FDA 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 ...

Real-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 ...

The 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, ...

FDA 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 ...