Glofitamab for Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on chronic corticosteroids or immunosuppressive therapy, you may need to adjust your treatment as these are generally excluded unless at low doses. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Glofitamab for lymphoma?
Glofitamab has shown promising results in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with some patients achieving complete or partial responses. In a real-world study, the median overall survival was 8.8 months, and the estimated 1-year progression-free survival rate was 83% for treatment-responsive patients.12345
Is Glofitamab safe for humans?
Glofitamab has been studied for safety in people with B-cell lymphomas. Some patients experienced serious side effects, including cytokine release syndrome (a severe immune reaction) and febrile neutropenia (fever with low white blood cell count), which led to deaths in a few cases. However, these side effects are not experienced by everyone, and the treatment has shown promise in patients who have limited options.12356
What makes the drug Glofitamab unique for treating lymphoma?
Glofitamab is unique because it is a bispecific antibody that simultaneously targets CD20 on B cells and CD3 on T cells, helping the immune system attack cancer cells. Its novel 2:1 structure allows for better binding and a longer half-life, making it a promising option for patients with relapsed or refractory B-cell lymphomas who have limited treatment options.12356
What is the purpose of this trial?
The goal of this clinical research study is to learn if glofitamab can help to prevent recurrence of LBCL in patients who have achieved CR after standard first-line therapy but have tested positive for MRD. The safety of glofitamab will also be studied.
Research Team
Dai Chihara, M D
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
Adults over 18 with certain types of large B-cell lymphoma who've had a complete response to first-line therapy but still have minimal residual disease (MRD). They must be in good health, understand the study, and agree to use contraception. Excluded are those with significant heart issues, recent surgeries or transfusions, other cancers within 3 years, severe allergies to therapies, immune conditions or treatments that could interfere.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive glofitamab to determine the rate of undetectable MRD and evaluate safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Glofitamab
Glofitamab is already approved in United States for the following indications:
- Relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL), or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD