31 Participants Needed

Mosunetuzumab + Polatuzumab Vedotin for Diffuse Large B-Cell Lymphoma

MC
Overseen ByMedical College of Wisconsin Cancer Center Clinical Trials Office
Age: 65+
Sex: Any
Trial Phase: Phase 2
Sponsor: Medical College of Wisconsin
Must be taking: Entecavir prophylaxis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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

NS

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

I have received at least one dose of an FDA-approved COVID-19 vaccine.
I am 70-74 years old and considered unfit or frail due to multiple health conditions.
I agree to either not have sex or use birth control, and not donate sperm during the trial.
See 14 more

Exclusion Criteria

I currently have an active infection.
Unable or unwilling to sign consent
I have had a stem cell transplant before.
See 24 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Mosunetuzumab and Polatuzumab Vedotin with split-dose CHP chemotherapy for up to six cycles

24 weeks
12 visits (in-person)

Interim Assessment

Interim response assessment with PET/CT and MRD testing to determine eligibility for abbreviated treatment

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Cyclophosphamide
  • Doxorubicin
  • Mosunetuzumab
  • Polatuzumab Vedotin
Trial Overview The study is testing if adding mosunetuzumab (Mosun) and polatuzumab vedotin (Pola) to a split-dose CHP chemotherapy regimen improves outcomes in these patients. It's a phase 2 study, meaning it focuses on the efficacy of this combination treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Mosum-Pola-SD-CHPExperimental Treatment6 Interventions
Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for six cycles. Day 1 ("A" part of cycle) Polatuzumab Vedotin 1.8 mg/kg Intravenous (IV); Mosunetuzumab (Cycle 1A) 5 mg Subcutaneous (SC); Cyclophosphamide 375 mg/m\^2 IV; Doxorubicin 25 mg/m\^2 IV; Prednisone 50 mg Orally Day 2 ("A" part of cycle) Pegfilgrastim 6 mg SC Day 8 ("A" part of cycle) Mosunetuzumab 45 mg SC Day 15 ("B" part of cycle) Mosunetuzumab (Cycle 1B-6B) 45 mg SC; Cyclophosphamide 375 mg/m\^2 IV; Doxorubicin 25 mg/m\^2 IV; Prednisone 50 mg Orally Day 16 ("B" part of cycle) Pegfilgrastim 6 mg SC

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Cytoxan for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma
  • Rheumatoid arthritis
🇪🇺
Approved in European Union as Endoxan for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma
  • Rheumatoid arthritis
🇨🇦
Approved in Canada as Neosar for:
  • Breast cancer
  • Ovarian cancer
  • Multiple myeloma
  • Leukemia
  • Lymphoma
  • Rheumatoid arthritis
🇯🇵
Approved in Japan as Endoxan for:
  • 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

Trials
645
Recruited
1,180,000+

Findings from Research

In a phase 3 trial involving 879 patients with untreated intermediate-risk or high-risk diffuse large B-cell lymphoma (DLBCL), the modified regimen pola-R-CHP (which replaces vincristine with polatuzumab vedotin) showed a significantly higher progression-free survival rate at 2 years (76.7%) compared to the standard R-CHOP regimen (70.2%).
The overall survival rates at 2 years were similar between the pola-R-CHP and R-CHOP groups (88.7% vs. 88.6%), indicating that while pola-R-CHP may reduce the risk of disease progression, it does not significantly improve overall survival compared to the standard treatment.
Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma.Tilly, H., Morschhauser, F., Sehn, LH., et al.[2022]
In a study of 71 patients with relapsed/refractory diffuse large B-cell lymphoma, the combination of polatuzumab vedotin with bendamustine and rituximab (Pola-BR) showed an overall response rate of 47.9%, with a complete response rate of 32.4% after a median of 3 treatment cycles.
The treatment demonstrated a manageable safety profile, with the most common severe side effects being grade 3-4 neutropenia and thrombocytopenia, indicating that Pola-BR is a promising and effective option for this patient population.
Polatuzumab vedotin, rituximab, and bendamustine combination in relapsed or refractory diffuse large B-cell lymphoma: a real-world data from Turkey.Dal, MS., Ulu, BU., Uzay, A., et al.[2023]
Polatuzumab vedotin, when combined with bendamustine and rituximab (polatuzumab-BR), is an effective treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), offering a new therapeutic avenue for those who do not respond to standard treatments.
This combination therapy is considered safe and is particularly beneficial for transplant-ineligible patients, with ongoing trials exploring its use alongside other treatments like CAR-T therapy.
An evaluation of polatuzumab vedotin for the treatment of patients with diffuse large B-cell lymphoma.Walji, M., Assouline, S.[2021]

References

Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. [2022]
Polatuzumab vedotin, rituximab, and bendamustine combination in relapsed or refractory diffuse large B-cell lymphoma: a real-world data from Turkey. [2023]
An evaluation of polatuzumab vedotin for the treatment of patients with diffuse large B-cell lymphoma. [2021]
Two-weekly dose-adjusted (DA)-EPOCH-like chemotherapy with high-dose dexamethasone plus rituximab (DA-EDOCH14-R) in poor-prognostic untreated diffuse large B-cell lymphoma. [2015]
Polatuzumab vedotin to treat relapsed or refractory diffuse large B-cell lymphoma, in combination with bendamustine plus rituximab. [2021]
Dose-adjusted EPOCH-R vs. R-CHOP in frontline management of Waldeyer's ring diffuse large B-cell lymphoma: a retrospective study from a single institution. [2023]
Long-term outcomes of R-CEOP show curative potential in patients with DLBCL and a contraindication to anthracyclines. [2021]
DA-EPOCH-R combined with high-dose methotrexate in patients with newly diagnosed stage II-IV CD5-positive diffuse large B-cell lymphoma: a single-arm, open-label, phase II study. [2023]
Non-pegylated liposomal doxorubicin in lymphoma: patterns of toxicity and outcome in a large observational trial. [2018]
Polatuzumab vedotin in relapsed / refractory aggressive B-cell lymphoma. [2022]
Profile of Polatuzumab Vedotin in the Treatment of Patients with Relapsed/Refractory Non-Hodgkin Lymphoma: A Brief Report on the Emerging Clinical Data. [2022]
United we stand: Double targeting of CD79B and CD20 in diffuse large B-cell lymphoma. [2023]
13.United Statespubmed.ncbi.nlm.nih.gov
Polatuzumab Vedotin Approved for DLBCL. [2020]
Polatuzumab Vedotin: First Global Approval. [2023]
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