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New treatment option for Follicular Lymphoma
Official title Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma
ClinicalTrials.gov ID: NCT04792502
What this study is testing
What is Mosunetuzumab?
Mosunetuzumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for follicular lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Histologically confirmed diagnosis of:
- 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...
You likely can't join if
- 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.
- Known NYHA class 3/4 congestive heart failure, LVEF \<40%, myocardial infarction within 6 months prior to enrollment, unstable angina, or unstable...
- Chronic obstructive pulmonary disease (COPD) requiring oral corticosteroids or chronic oxygen.
See the full eligibility criteria
Who can join
- 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.
- Histologically confirmed diagnosis of:
- 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...
- Agreement to provide, if available, lymphoma tissue for correlative analyses.
- At least one bi-dimensionally measurable nodal lesion, defined as \>1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \>1.0 cm in its longest diameter; with the exception...
- No prior systemic therapy for B-cell lymphoma, except for palliative corticosteroids; prior local therapy (surgery, radiation therapy, or antibiotics) is allowed.
- Indication to start systemic therapy for lymphoma:
- Patients with FL must meet one of the GELF criteria:
- any mass ≥7 cm (except spleen);
- at least 3 nodes \>3 cm in diameter;
- symptomatic spleen enlargement;
- local symptoms or compromise of normal organ function due to tumor mass;
- presence of ascites or pleural effusion;
- presence of B symptoms (fever, night sweats, or unintentional weight loss of \>10% over ≤6 months);
- serum lactate dehydrogenase or beta-2-microglobulin above upper limit of normal;
- cytopenias due to underlying lymphoma (i.e., absolute neutrophil count \<1.0 × 109/L, hemoglobin \<10 g/dL, and/or platelet count \<100 × 109/L).
- Patients with MZL must have an indication to start therapy as assessed by the investigator.
- Performance status ECOG 0, 1, or 2.
- Adequate hematologic function (unless due to underlying lymphoma as established by bone marrow involvement or splenomegaly):
- hemoglobin ≥9 g/dL,
- absolute neutrophil count ≥1.0 x 109/L,
- platelet count ≥75 x 109/L.
- Glomerular filtration rate (GFR) ≥40 mL/min/1.73m2 using the Mayo Quadratic Formula.
- The effects of mosunetuzumab on the developing human fetus are unknown. For this reason and because lenalidomide used in this trial is known to be teratogenic, women of child-bearing potential and men must agree to use...
- Agreement to enroll in and comply with all local requirements of the REVLIMID® (lenalidomide) Risk Evaluation and Mitigation Strategy (REMS®) program for the purpose of lenalidomide acquisition.
What rules you out
- 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.
- Known NYHA class 3/4 congestive heart failure, LVEF \<40%, myocardial infarction within 6 months prior to enrollment, unstable angina, or unstable arrhythmia.
- Chronic obstructive pulmonary disease (COPD) requiring oral corticosteroids or chronic oxygen.
- History of autoimmune disease, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, idiopathic pulmonary fibrosis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel...
- Use of any systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid...
- Any of the following conditions:
- active bacterial infection requiring antibiotics
- known or suspected chronic active Epstein Barr virus (CAEBV) infection
- history of hemophagocytic lymphohistiocytosis (HLH)
- confirmed progressive multifocal leukoencephalopathy (PML)
- known active EBV or CMV viremia
- positive test for hepatitis B surface antigen (HBSAg). Patients with a positive total/IgG hepatitis B core antibody (HBcAb) may participate if hepatitis B virus (HBV) DNA is undetectable at screening, if they agree to...
- positive hepatitis C virus (HCV) antibody, unless a negative polymerase chain reaction (PCR) for HCV is documented
- positive test for HIV.
- Administration of a live, attenuated vaccine within 4 weeks before first mosunetuzumab dose or anticipation that such a live, attenuated vaccine will be required during the study.
- Current or past history of CNS disease, including stroke, epilepsy, or CNS vasculitis, or an advanced neurodegenerative disease; with the exception of: stroke \>2 years before registration without any residual...
- History of other malignancy that could affect compliance with the protocol or interpretation of results; patients with a curatively treated skin cancer, in situ cervical cancer, or another malignancy treated curatively...
- 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...
- Clinically significant liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
- Any major surgery within 4 weeks before the first dose of mosunetuzumab, other than lymph node biopsy for diagnosis.
- Evidence of other significant or uncontrolled medical or psychiatric conditions that could affect compliance with the protocol.
- Any of the following abnormal laboratory values within 14 days prior to first dose of mosunetuzumab:
- AST or ALT \>3x ULN
- total bilirubin \>2 x ULN (unless due to Gilbert syndrome with indirect hyperbilirubinemia only)
- INR\>1.5 x ULN without anticoagulation
- PTT or APTT \>1.5x ULN in the absence of lupus anticoagulant.
- Any radiation therapy within 2 weeks prior to first dose of mosunetuzumab.
- Pregnancy, breast-feeding, or prisoner status. Women of childbearing potential must have a negative pregnancy test within 2 weeks before first dose of mosunetuzumab, and must undergo repeat pregnancy testing during each...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- New Brunswick, New Jersey, United States
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; New Brunswick, New Jersey, United States; Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.