Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients
- Conditions
- Splenic Marginal Zone Lymphoma
- Registration Number
- NCT05735834
- Lead Sponsor
- International Extranodal Lymphoma Study Group (IELSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria:<br><br> - Ability to understand and willingness to sign a written informed consent in<br> accordance with ICH/GCP regulations before registration and prior to any<br> trial-specific procedures.<br><br> - Confirmed diagnosis of SMZL, including Matutes immunophenotype score <3, absence of<br> CD103 and CD25 expression by flow cytometry, absence of Cyclin D1, BCL6, and CD10<br> expression by immunohistochemistry, and absence of the MYD88 L265P mutation.<br> Patients with prominent splenomegaly and involvement of the splenic hilar and/or<br> extra hilar lymph nodes are eligible<br><br> - Previously untreated disease. Patients with prior hepatitis C virus (HCV) infection<br> who underwent HCV eradication and have persistent SMZL after 3 months<br> post-eradication can be included. Patients with previous splenectomy are excluded.<br><br> - Treatment needs according to the ESMO guideline criteria<br><br> - Measurable lesions<br><br> - Age = 18 years.<br><br> - European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.<br><br> - Absolute neutrophil count (ANC) = 1.0 x 109/L, platelet count = 50 x 109/L, Hb > 7.5<br> g/dl. Values below such thresholds are allowed if attributable to the underlying<br> lymphoma. Transfusions are allowed if clinically indicated during screening.<br><br> - Adequate hepatic and renal function and coagulation parameters<br><br> - Patient able and willing to swallow trial drugs as whole tablet/capsule<br><br>Exclusion Criteria:<br><br> - Previous splenectomy.<br><br> - Any systemic therapy for SMZL.<br><br> - Patients with central nervous system (CNS) involvement.<br><br> - Prior malignancy (other than the disease under study) within the past 2 years,<br> except for curatively treated basal or squamous skin cancer, superficial bladder<br> cancer, carcinoma in situ of the cervix or breast, or localized Gleason score = 6<br> prostate cancer.<br><br> - Clinically significant cardiovascular disease<br><br> - History of cerebrovascular accident or intracranial hemorrhage within 6 months<br> before registration and known bleeding disorders (eg, von Willebrand's disease or<br> hemophilia).<br><br> - History of confirmed progressive multifocal leukoencephalopathy (PML).<br><br> - Concomitant diseases that require anticoagulant therapy with warfarin or<br> phenprocoumon or other vitamin K antagonists and patients treated with dual<br> anti-platelet therapy. Patients being treated with factor Xa inhibitors (eg,<br> rivaroxaban, apixaban, edoxaban), direct thrombin inhibitors (e. dabigatran) low<br> molecular weight heparin (LMWH), or single anti-platelet agents (eg. aspirin,<br> clopidogrel) can be included but must be properly informed about the potential risk<br> of bleeding.<br><br> - Malabsorption syndrome or other condition that precludes the enteral route of<br> administration.<br><br> - Any uncontrolled active systemic infection requiring intravenous antimicrobial<br> treatment.<br><br> - Known human immunodeficiency virus (HIV) infection.<br><br> - Active COronaVIrus Disease 19 (COVID-19) infection or non-compliance with the<br> prevailing hygiene measures regarding the COVID-19 pandemic.<br><br> - Active chronic hepatitis C or hepatitis B virus infection<br><br> - Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune.<br> thrombocytopenia) requiring steroid therapy with > 20 mg daily of prednisone dose or<br> equivalent.<br><br> - Known hypersensitivity to trial drugs or any component of the trial drugs.<br><br> - Concomitant treatment with strong CYP3A inducers or inhibitors<br><br> - Other severe acute or chronic medical or psychiatric condition or laboratory<br> abnormality that in the opinion of the investigator may increase the risk associated<br> with trial participation or investigational product administration or may interfere<br> with the interpretation of trial results and/or would make the patient inappropriate<br> for enrolment into this trial.<br><br> - Pregnancy or breastfeeding.<br><br> - Concurrent participation in another therapeutic clinical trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) rate at 3 years
- Secondary Outcome Measures
Name Time Method Complete remission rates - Lugano 2014 criteria;Best response;Complete remission rates - Matutes criteria;Best response - Matutes criteria;Time to next anti-lymphoma treatment (TTNT);Duration of response (DoR);Overall Survival (OS);Treatment Emergent Adverse Events (AEs)