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New treatment option for Lymphoma
Official title A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma
ClinicalTrials.gov ID: NCT06563505
What this study is testing
What is Mosunetuzumab?
Mosunetuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lymphoma.
Also referred to as RO7030816.
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
- To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL.
- 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
- Patients must meet the following criteria for study entry:
- Histologically diagnosed marginal zone lymphoma (any subtypes) o Low grade or indolent B-cell lymphoma unclassifiable is also eligible
- Have received at least 1 prior treatment including CD20 monoclonal antibody
- Patients have relapsed or refractory disease to their most recent regimen
- Stage II, III or IV disease
You likely can't join if
- people will be ineligible for this study if they meet any of following criteria:
- Known active central nervous system lymphoma or leptomeningeal disease.
- Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent (investigational or otherwise) within 4 weeks or five...
- Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 3 years and felt to be at low risk for...
- Adequately treated localized skin cancer without evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
See the full eligibility criteria
Who can join
- Patients must meet the following criteria for study entry:
- Histologically diagnosed marginal zone lymphoma (any subtypes) o Low grade or indolent B-cell lymphoma unclassifiable is also eligible
- Have received at least 1 prior treatment including CD20 monoclonal antibody
- Patients have relapsed or refractory disease to their most recent regimen
- Stage II, III or IV disease
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of mosunetuzumab and zanubrutinib combination in patients \<18 years of age, children are excluded from this study.
- Performance status ≤2 on the ECOG scale (≤3 if due to lymphoma)
- Requiring systemic therapy assessed by investigator based on tumor size, symptoms and/or GELF criteria
- A nodal or extranodal (except spleen) mass \> 7 cm in its greater diameter
- At least 3 nodal or extranodal sites ≥ 3 cm in diameter
- Presence of at least one B symptom
- Fever (\>38 C), night sweats, weight loss \> 10% in the past 6 months
- Symptomatic splenomegaly (or size \>13cm)
- Impending organ compression or involvement (ureteral, orbital, gastrointestinal)
- Any of the following cytopenias due to bone marrow involvement of lymphoma
- Hemoglobin ≤ 10 g/dL
- Platelets ≤ 100 x 109/L
- Absolute neutrophil count (ANC) \< 1.5x109/L
- Pleural effusion or ascites
- LDH \> ULN or β2 microglobulin \> ULN
- Bi-dimensionally measurable disease, with at least one nodal lesion ≥ 1.5 cm or one extra-nodal lesion \> 1 cm in longest diameter by CT, PET/CT, and/or MRI
- people with splenic MZL who do not meet the radiographically measurable disease criteria are eligible for participation if spleen is enlarged over 16 cm and MZL is histologically confirmed by bone marrow biopsy or...
- people with EMZL such as skin of conjunctival EMZL who do not meet the radiographically measurable disease criteria are eligible for participation if at least one of the skin lesions is histologically confirmed as MZL...
- Patients must have adequate organ and marrow function as defined below:
- Total bilirubin ≤ 1.5 institutional ULN, unless consistent with Gilbert's (ratio between total and direct bilirubin \> 5)
- AST (SGOT) and ALT (SGPT) ≤ 3 x institutional ULN
- Alkaline phosphatase \< 2.5 ULN
- Creatinine clearance ≥ 40 ml/min calculated by modified Cockcroft-Gault formula
- Blood counts below if without lymphoma cause for cytopenia
- Hemoglobin ≥ 8 g/dL
- Platelets ≥ 75 x 109/L
- Absolute neutrophil count (ANC) ≥ 1.0x109/L
- Blood counts below if cytopenia are due to lymphoma (such as bone marrow involvement or splenomegaly)
- Hemoglobin ≥ 6 g/dL (no transfusion within 7 days prior to treatment)
- Platelets ≥ 50 x 109/L
- Absolute neutrophil count (ANC) ≥ 0.5x109/L
What rules you out
- people will be ineligible for this study if they meet any of following criteria:
- Known active central nervous system lymphoma or leptomeningeal disease.
- Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent (investigational or otherwise) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to first...
- Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 3 years and felt to be at low risk for recurrence by the treating physician, except:
- Adequately treated localized skin cancer without evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of lenalidomide...
- Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection...
- Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. Hepatitis B or C serologic status: people who are hepatitis B core antibody (anti-HBc) positive...
- History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of...
- Use of strong/moderate inhibitors within 7 days or 5 half-lives prior to the first dose of zanubrutinib; usage of strong/moderate CYP3A inducers within 14 days prior to the first dose of zanubrutinib.
- Requiring ongoing therapy with strong or moderate CYP3A inducers.
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4...
- Significant screening electrocardiogram (ECG) abnormalities including 2nd degree atrioventricular (AV) block, type II AV block, or 3rd degree block.
- Active bleeding or known bleeding diathesis (e.g., von Willebrand's disease) or hemophilia.
- History of stroke or intracranial hemorrhage within 6 months prior to study entry.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.