A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma

Recruiting now · Phase 2

Conditions studied: Follicular Lymphoma, Lymphoma

In brief

The purpose of this study is to find out if mosunetuzumab is an effective treatment in people with follicular lymphoma that was recently diagnosed and have not yet received any treatments for their disease.

Key facts

Study ID

NCT05389293

Run by

Memorial Sloan Kettering Cancer Center

People needed

152

Starts

2022-05-27

Expected to finish

2026-12-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed Informed Consent Form(s)
• Ability to comply with all the study-related procedures, in the investigator's judgement
• Age 18 years or older
• ECOG performance Status of 0, 1, or 2 [Appendix 2]
• Untreated histologically documented FL of grade 1, 2, or 3A
• Stage II bulky (noncontiguous), III, or IV bulky or high burden disease [Appendix 3]
• Need of systemic therapy as evidenced by at least one of the following criteria [also see Appendix 4]:
• Bulky disease defined as:
• Nodal or extranodal mass \> 7cm in maximum diameter
• ≥ 3 nodal or extranodal sites each with a diameter ≥ 3 cm
• Presence of any of the following constitutional symptoms:
• Fever (\>38C) of unclear etiology
• Night sweats
• Weight loss \>10% within the prior 6 months
• Symptomatic splenomegaly
• Mass-related symptoms
• End-organ damage (e.g., elevated creatinine or elevated liver enzymes) that is clearly related to lymphomatous infiltration in the opinion of the investigator
• Any one of the following cytopenias due to lymphoma:
• Hemoglobin \< 10g/dL
• Platelets \<100 x 10\^9/L
• Absolute neutrophil count (ANC) \< 1.5 x 10\^9/L
• Pleural or peritoneal serous effusion (irrespective of cell content)
• Patients with absolute lymphocytosis ≥5,000 cells/µL in the peripheral blood may be allowed to participate after discussion with the study PI
• Must be considered as a potential candidate for chemoimmunotherapy in the judgement of the treating physician
• Must have at least one bi-dimensionally measurable lesion (\>1.5 cm in its largest dimension for nodal lesions, or \>1.0 cm in its largest dimension for extranodal lesions by computerized tomography [CT] scan or MRI)

You may not qualify if…

• Inability to comply with all the study-related procedures, in the investigator's judgement.
• FL grade 3B or transformed FL
• Patients not meeting criteria for systemic therapy as outlined in section 6.1 and Appendix 4
• Patients unfit for chemoimmunotherapy for reasons including, but not limited to, advanced age and medical comorbidities
• FL presenting with isolated extra-nodal localizations, such as duodenal FL, cutaneous FL or FL of the testis
• Pediatric FL
• Prior anti-lymphoma therapy
• Prior solid organ transplantation
• Prior allogeneic stem cell transplantation within 5 years of FL diagnosis. Previously transplanted patients must be off all GVHD-related prophylaxis in order to be considered eligible.
• Current or prior central nervous system (CNS) lymphoma
• Current or past history of significant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
• Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed
• Patients with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed
• Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease [see Appendix 6], myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
• Significant active pulmonary disease (e.g., bronchospasm or obstructive pulmonary disease)
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to first mosunetuzumab administration
• Known or suspected chronic active Epstein-Barr Virus infection
• Serologic or PCR test results indicating acute or chronic HBV infection
• ° Patients whose HBV infection status cannot be determined by serologic test results (www.cdc.gov/hepatitis/hbv/pdfs/serologicchartv8.pdf) must be negative for HBV by PCR to be eligible for study participation.
• Acute or chronic HCV infection
• ° Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation.
• Serologic test results indicating HIV infection
• Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
• Patients must not receive live, attenuated vaccines (e.g., FluMist®) while receiving study treatment or after the last dose until B-cell recovery to the normal ranges. Killed vaccines or toxoids should be given at least 4 weeks prior to the first dose of study treatment to allow development of sufficient immunity.
• Inactivated influenza vaccination during influenza season and the COVID-19 vaccination at any time are allowed. Please see section 10.3.2 (permitted concomitant therapy) for additional guidance on SARS-CoV-2 vaccine administration and timing

Where it is running

• Georgetown University (Data Collection Only) — Washington D.C., District of Columbia, United States (enrolling)
• Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities — Basking Ridge, New Jersey, United States (enrolling)
• Hackensack Meridian Health (Data collection only) — Hackensack, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Suffolk- Commack (Limited protocol activities) — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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