Mosunetuzumab + Chemotherapy for Diffuse Large B-Cell Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does mention that systemic immunosuppressive medications are generally not allowed, except for certain corticosteroids. Herbal therapies for lymphoma and cannabis products are also not permitted during the study.
What data supports the effectiveness of the drug Mosunetuzumab combined with chemotherapy for treating diffuse large B-cell lymphoma?
In a study with 40 patients who had not been treated before for diffuse large B-cell lymphoma, the combination of Mosunetuzumab and chemotherapy showed promising results, with 87.5% of patients responding to the treatment and 85% achieving complete response. The study also reported that 65.4% of patients did not see their disease progress for at least two years.12345
Is Mosunetuzumab combined with chemotherapy safe for humans?
Mosunetuzumab combined with chemotherapy has shown a manageable safety profile in studies, with common side effects including cytokine release syndrome (a reaction that can cause fever and low blood pressure) and neutropenia (a low level of white blood cells). Serious side effects were rare, but some patients experienced severe reactions.14567
How is the drug Mosunetuzumab with chemotherapy unique for treating Diffuse Large B-Cell Lymphoma?
Mosunetuzumab is a novel drug because it is a bispecific antibody that engages T-cells to target and destroy cancerous B-cells, offering a new approach compared to traditional chemotherapy. This mechanism is different from standard treatments, which typically do not involve redirecting the immune system in this way.12346
What is the purpose of this trial?
This phase Ib/II clinical trial tests the safety, side effects, and effectiveness of mosunetuzumab with chemotherapy for the treatment of patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as mosunetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone work in different ways to stop the growth of cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mosunetuzumab with chemotherapy may be safe, tolerable and/or effective in treating patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma.
Research Team
Stephen E. Spurgeon
Principal Investigator
OHSU Knight Cancer Institute
Eligibility Criteria
This trial is for patients with untreated high grade B cell lymphoma or diffuse large B cell lymphoma that tests positive for c-Myc rearrangement. Participants should not have had previous treatments and must be suitable for immunotherapy and chemotherapy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mosunetuzumab and DA EPOCH chemotherapy in cycles of 21 days for up to 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Chemotherapy
- Mosunetuzumab
Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Breast cancer
- Metastatic breast cancer
- Various other cancers
- Breast cancer
- Metastatic breast cancer
- Various other cancers
- Breast cancer
- Metastatic breast cancer
- Various other cancers
- Breast cancer
- Metastatic breast cancer
- Various other cancers
- Breast cancer
- Metastatic breast cancer
- Various other cancers
- Breast cancer
- Metastatic breast cancer
- Various other cancers
Find a Clinic Near You
Who Is Running the Clinical Trial?
OHSU Knight Cancer Institute
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
Oregon Health and Science University
Collaborator