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A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

An Open-Label, Multicenter, Single-Arm, Sequential Phase-2 Study of Mosunetuzumab Alone or With Zanubrutinib for the Treatment of Patients With Newly Diagnosed Follicular Lymphoma in Need of Systemic Therapy

NCT05389293•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

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.

Detailed Description

After completing enrollment of the initial 53 subjects, the researchers plan to expand the study by an additional 23 subjects.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+33 more criteria

Exclusion Criteria

•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
+53 more criteria

Locations (9)

Georgetown University (Data Collection Only)

Washington D.C., District of Columbia, United States

Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities

Basking Ridge, New Jersey, United States

Hackensack Meridian Health (Data collection only)

Hackensack, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (Limited protocol activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited protocol activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States

Key Dates

Start Date

May 27, 2022

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

December 31, 2025

Enrollment

152

ESTIMATED participants

Conditions

Follicular LymphomaLymphoma

Interventions

Mosunetuzumab

DRUG

Zanubrutinib

DRUG

Contacts

Lorenzo Falchi, MD

CONTACT

646-608-3705 FalchiL@mskcc.org

Gilles Salles, MD, PhD

CONTACT

646-608-4153 SallesG@mskcc.org

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NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

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A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

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DLBCLDiffuse Large B-Cell Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

U69-CART-Cells For R/R T-ALL