Comparison between rituximab plus zanubrutinib versus rituximab monotherapy in untreated splenic marginal zone lymphoma patients

Phase 1

Recruiting

• Conditions: Splenic marginal zone lymphoma; MedDRA version: 21.0Level: PTClassification code: 10062113Term: Splenic marginal zone lymphoma Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-503755-10-00
• Lead Sponsor: Association International Extranodal Lymphoma Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-15
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent in accordance with ICH/GCP regulations before registration and prior to any trial-specific procedures., Absolute neutrophil count (ANC) = 1.0 x 109/L, platelet count = 50 x 109/L, Hb > 7.5 g/dl. Values below such thresholds are allowed if attributable to the underlying lymphoma. Transfusions are allowed if clinically indicated during screening., Adequate hepatic and renal function and coagulation parameters, Patient able and willing to swallow trial drugs as whole tablet/capsule., Female subjects who are of non-reproductive potential and female subjects of childbearing potential with a negative serum pregnancy test upon study entry., Male and female subjects who agree to use highly effective methods of birth control during the period of therapy and for 12 months after the last dose of rituximab and 30 days after the last dose of zanubrutinib., Confirmed diagnosis of SMZL, including Matutes immunophenotype score <3, absence of CD103 and CD25 expression by flow cytometry, absence of Cyclin D1, BCL6, and CD10 expression by immunohistochemistry, and absence of the MYD88 L265P mutation. Patients with prominent splenomegaly and involvement of the splenic hilar and/or extra hilar lymph nodes are eligible., Previously untreated disease. Patients with prior hepatitis C virus (HCV) infection who underwent HCV eradication and have persistent SMZL after 3 months post-eradication can be included. Patients with previous splenectomy are excluded., Treatment needs according to the ESMO guideline criteria., Measurable lesions, Age = 18 years., European Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

Exclusion Criteria

Previous splenectomy, History of confirmed progressive multifocal leukoencephalopathy, Concomitant diseases that require anticoagulant therapy with warfarin or phenprocoumon or other vitamin K antagonists and patients treated with dual anti-platelet therapy. Patients being treated with factor Xa inhibitors (eg, rivaroxaban, apixaban, edoxaban), direct thrombin inhibitors (e. dabigatran) low molecular weight heparin (LMWH), or single anti-platelet agents (eg. aspirin, clopidogrel) can be included but must be properly informed about the potential risk of bleeding, Malabsorption syndrome or other condition that precludes the enteral route of administration, Other sever acute or chronic medical or psychiatric condition or laboratory abnormalities which may increase the risk associates with trial participation and/or would make the patient inappropriate for enrolment into this trial., Pregnancy or breastfeeding., Concurrent participation in another therapeutic clinical trial., Any uncontrolled active systemic infection requiring intravenous antimicrobial treatment, known human immunodeficiency virus (HIV) infection, active COronaVIrus Disease 19 (COVID-19) infection, presence of viral hepatitis B surface antigen (HBsAg) or viral hepatitis B core antibody (HBcAb), Presence of HCV antibody, Active, uncontrolled autoimmune phenomenon, Concomitant treatment with strong CYP3A inducers or inhibitors., Any systemic therapy for SMZL., Patients with central nervous system (CNS) involvement., Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score = 6 prostate cancer., Clinically significant cardiovascular disease, History of cerebrovascular accident or intracranial hemorrhage within 6 months before registration and known bleeding disorders (eg, von Willebrand’s disease or hemophilia).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified