Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma
ConditionExtranodal 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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Mosunetuzumab
DrugMosunetuzumab will be administered via subcutaneous (SC) injection using a step-up dosing model. Participants will receive Mosunetuzumab on days 1, 8, and 15 of Cycle 1, and on day 1 of Cycles 2 through 8 as follows: * Cycle 1 Day 1: 5mg * Cycle 1 Day 8: 45mg * Cycle 1 Day 15: 45mg * Cycles 2 through 8, Day 1: 45mg
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Mosunetuzumab Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Response (CR) Rate
The number of participants with best overall response of complete response (CR) to protocol therapy will be reported. Response will be assessed using Cheson 2014 criteria if disease is not FDG-avid in initial screening, and by revised Lugano 2014 criteria if screening Fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) (FDG PET/CT) demonstrated FDG-avid disease.
Time frame
Up to 12 monthsSecondary outcomes
1
Overall Response Rate (ORR)
The number of participants with best overall response of complete response (CR) or partial response (PR) to protocol therapy will be reported. Response will be assessed using Cheson 2014 criteria if disease is not FDG-avid in initial screening, and by revised Lugano 2014 criteria if screening FDG-PET/CT demonstrated FDG-avid disease.
Time frame
Up to 12 months2
Partial Response (PR) Rate
The number of participants with partial response (PR) to protocol therapy will be reported. Response will be assessed using Cheson 2014 criteria if disease is not FDG-avid in initial screening, and by revised Lugano 2014 criteria if screening FDG-PET/CT demonstrated FDG-avid disease.
Time frame
Up to 12 months3
Number of Participants Experiencing treatment-related adverse events
The number of participants experiencing toxicity will be reported as the number of participants experiencing treatment-related adverse events (AEs), and serious adverse events (SAEs) regardless of attribution. Toxicity will be assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Time frame
Up to 13 months4
Number of Participants Experiencing Cytokine Release Syndrome Adverse Events
The number of participants experiencing cytokine release syndrome (CRS) related adverse events (AEs) will be reported. CRS AEs will be assessed according to the American Society for Transplantation and Cellular Therapy (ASTCT) Consensus 2019 Grading Criteria.
Time frame
Up to 13 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov