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 range18 Years
SexALL
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…