Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University
About this trial
BrUOG-401 is a prospective, single-arm, phase 2 trial of first-line therapy in adult patients with previously untreated FL or MZL. All patients will be assigned the same initial treatment plan, modified by interim response assessment (IRA) after Cycle 4. All patients will start treatment with four 21-day cycles (C1-4) of mosunetuzumab alone (using step-up dosing during C1), followed by IRA. Patients who achieve CR at IRA will continue with additional 4 cycles (C5-8) of mosunetuzumab. Patients who achieve PR at IRA will receive mosunetuzumab with lenalidomide augmentation during C5-8. Primary response assessment (PRA) will occur after C8. Patients who remain in PR at PRA will continue for additional 4 cycles (extended augmentation).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures.
Age ≥18 years at the time of signing informed consent. Because no dosing or adverse event data are currently available on the use of mosunetuzumab in patients <18 years of age, they are excluded from this study.
follicular lymphoma (grade 1, 2, 3a, or not otherwise specified) or
marginal zone lymphoma (nodal, extranodal, or splenic), according to 2016 WHO classification and confirmed to express the CD20 antigen by immunohistochemistry or flow cytometry. Patients in whom definitive pathologic subtype of FL/MZL is undetermined due to limited biopsy material can be enrolled if in the investigator's opinion integrated clinicopathologic data are consistent with the eligible diagnosis.
Disqualifiers
Grade 3b follicular lymphoma or transformed lymphoma.
Prior treatment with any anti-CD20 antibody or lenalidomide for lymphoma.
Prior stem cell transplantation (autologous or allogeneic) or prior solid organ transplantation.
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
Trial design
Design model
Single group
Treatments tested in this trial
Mosunetuzumab
DrugAdministered subcutaneously by injection beginning with 5 mg and increasing to 45 mg.
Lenalidomide
DrugPatients in the augmentation cohort will be dosed continuously, 10 mg orally once daily, with or without food.
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Planned TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Complete Response Rate
The rate of complete response at the time of primary response assessment (PRA).
Time frame
At the end of Cycle 8 (each cycle is 21 days)Secondary outcomes
1
Progression Free Survival
PFS will be determined according to the guidance from the International Working Group. The following events will be counted for PFS: disease progression, disease recurrence, initiation of new line of therapy, or death from any cause.
Time frame
Time of study registration through end of follow-up, approximately 5 years.Sponsors and contacts
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Brown University
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov