Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIzidore Lossos, MD

About this trial

The purpose of this study is to test a new medication called Mosunetuzumab to see if it can help people with Extranodal Marginal Zone Lymphoma (EMZL). This study will include people who have not yet received any treatment for cancer and whose cancer is in stage I-IV. This study will help doctors understand if Mosunetuzumab improves outcomes in people with EMZL and if it is safe to use.

Eligibility criteria

Qualifiers

Men and women aged 18 years or older at the time of signing informed consent.

Able and willing to sign the informed consent form (ICF).

Ability to comply with the trial protocol.

Histologically confirmed EMZL presenting with stage I-IV disease.

Disqualifiers

Evidence of diffuse large B cell lymphoma (DLBCL) transformation. Participants with presumptive evidence of transformation based on clinical assessment of factors such as, but not limited to, increasing lactate dehydrogenase, rapidly worsening disease, or frequent B-symptoms, must be ruled out for a transformation to a more aggressive disease, such as DLBCL.

History of central nervous system lymphoma (either primary or metastatic) or leptomeningeal disease. Participants with Dural MZL are eligible.

Patients that need immediate cytoreduction.

Concurrent or previous anticancer therapy (eg, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).

Trial design

Treatments tested in this trial

  • Mosunetuzumab

Treatment groups

35 Participants
are divided into 1 treatment group

Sponsors and collaborators

Izidore Lossos, MD

Lead sponsor

University of Miami

Sponsor institution

Genentech, Inc.

Collaborator