Mosunetuzumab + Polatuzumab Vedotin for Diffuse Large B-Cell 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 immunosuppressant therapy for an active autoimmune disease, you may not be eligible unless exceptions apply. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug combination Mosunetuzumab and Polatuzumab Vedotin for treating Diffuse Large B-Cell Lymphoma?
Polatuzumab Vedotin, when combined with other drugs like bendamustine and rituximab, has shown effectiveness in treating relapsed or refractory Diffuse Large B-Cell Lymphoma, with a complete response rate of 40% compared to 18% for those not receiving Polatuzumab. This suggests that Polatuzumab Vedotin can be an effective part of treatment for this type of lymphoma.12345
Is the combination of Mosunetuzumab and Polatuzumab Vedotin safe for treating Diffuse Large B-Cell Lymphoma?
The safety of Mosunetuzumab and Polatuzumab Vedotin specifically is not addressed in the provided studies. However, treatments involving similar drugs like doxorubicin have shown manageable toxicity, though they can cause significant side effects such as heart issues and blood-related problems. It's important to discuss potential risks with your healthcare provider.46789
What makes the drug combination of Mosunetuzumab and Polatuzumab Vedotin unique for treating diffuse large B-cell lymphoma?
This drug combination is unique because it includes Polatuzumab Vedotin, an antibody-drug conjugate that targets CD79b on B cells and delivers a toxin to kill them, and Mosunetuzumab, which is a bispecific antibody that engages T cells to attack B cells. This dual approach aims to enhance the immune system's ability to fight the lymphoma.1011121314
What is the purpose of this trial?
This single-arm, interventional phase 2 study is designed to evaluate whether the inclusion of mosunetuzumab subcutaneous and polatuzumab vedotin (Mosun-Pola) to a split-dose CHP chemotherapy backbone will improve outcomes for elderly patients with a new diagnosis of diffuse large B-cell lymphoma.
Research Team
Nirav Shah, MD
Principal Investigator
Medical College of Wisconsin
Eligibility Criteria
This trial is for elderly patients newly diagnosed with diffuse large B-cell lymphoma. Specific eligibility details are not provided, but typically participants must meet certain health criteria and have no conditions that would exclude them from safely receiving the treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Mosunetuzumab and Polatuzumab Vedotin with split-dose CHP chemotherapy for up to six cycles
Interim Assessment
Interim response assessment with PET/CT and MRD testing to determine eligibility for abbreviated treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- Doxorubicin
- Mosunetuzumab
- Polatuzumab Vedotin
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical College of Wisconsin
Lead Sponsor