Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated… (NCT05169658) | Clinical Trial Compass
CompletedPhase 2
Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma
United States42 participantsStarted 2022-03-23
Plain-language summary
This phase II trial tests the effects of mosunetuzumab with or without polatuzumab vedotin and obinutuzumab for the treatment of patients with indolent B-cell non-Hodgkin lymphoma. Mosunetuzumab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a chemotherapy drug, called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD79b receptors, and delivers vedotin to kill them. Giving mosunetuzumab with polatuzumab vedotin and obinutuzumab may work better in treating patients with untreated indolent B-cell non-Hodgkin lymphoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of indolent B-cell non-Hodgkin lymphoma with no prior systemic therapy.
\* Eligible histologies based on 2016 World Health Organization (WHO) classification include:
* Follicular lymphoma (grade 1-2 or 3a)
* Marginal zone lymphoma. Patients with mucosa-associated lymphoid tissue (MALT) subtype of marginal zone lymphoma (MZL) may have relapsed or refractory disease after a course of antibiotic therapy
* Meet criteria for initiation of therapy that include one of the following:
* Symptomatic disease (including but not limited to pain/discomfort, b-symptoms)
* Threatened end-organ function
* Progressive cytopenias (leukopenia \[WBC \< 1,000/uL\] OR hemoglobin \< 10 g/dL OR platelets \< 100,000/uL)
* Steady progression
* Bulky disease (one site at least 7 cm or at least four sites of 3 cm)
* Hepatomegaly
* Splenomegaly
* Be willing and able to provide written informed consent for the trial
* Have had an informed discussion with the investigator as part of the consenting/screening process that included information on treatments for these conditions with known clinical benefit, and there is documented understanding that the patient is forgoing approved available therapies
* Be \>= 18 years of age on day of signing informed consent
* Have measurable fludeoxyglucose F-18 (FDG)-avid nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on computed tomography (CT) or FDG-positron emission t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial that has already completed recruitment, has the data been published or presented yet, and would the complete response rates observed tell us anything useful about whether this approach might work for my specific type of indolent B-cell lymphoma?
2This trial tests mosunetuzumab — a bispecific antibody — sometimes combined with polatuzumab vedotin and obinutuzumab, which is a more intensive combination; how do the side effect profiles of these combinations compare to standard first-line treatments you might recommend for my situation?
3Given that the trial focused on untreated indolent lymphoma including follicular lymphoma grades 1 through 3a and marginal zone lymphoma, and my diagnosis falls into one of those categories, is a watch-and-wait approach or standard chemoimmunotherapy still a reasonable option to consider before pursuing something like what was studied here?
4Since this trial measured complete response as its primary goal, what does achieving a complete response actually mean for long-term outcomes in indolent lymphoma, and is a complete response more or less likely with standard care versus what was tested here?
5Because recruitment is already closed, could results from this trial influence treatment options available to me now, or are there similar open trials or approved combinations I should be asking about instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete Response (CR)
Timeframe: At the end of treatment completion, an average of 5.5 months after starting treatment.