Tests zuberitamab with bendamustine in untreated follicular lymphoma

Trial details

Who runs it

Sun Yat-sen University

Trial code

NCT06757894

Record updated

3 January 2025

Original description

This is a prospective, single-arm, multicenter, phase ll clinical trial to evaluate the efficacy and safety of Zuberitamab and Bendamustine combination treatment in treatment-naïve follicular lymphoma patients.Read full original descriptionShow less

Efficacy and Safety of Zuberitamab and Bendamustine Combination Treatment Followed by Monotherapy Maintenance in Treatment-naïve Follicular Lymphoma: an Open-label, Prospective, Multicenter, Single-arm Phase II Clinical Study

This is a prospective, single-arm, multicenter, phase ll clinical trial to evaluate the efficacy and safety of Zuberitamab and Bendamustine combination treatment in treatment-naïve follicular lymphoma patients.

Inclusion: Voluntary signing of informed consent; Age ≥ 18 years, no gender restriction; Histologically confirmed follicular lymphoma (grades 1-3a), CD20 positive by immunohistochemistry; No prior systemic treatment for FL; Ann Arbor stage III/IV, or stage II with bulky disease (bulky disease defined as a tumor diameter ≥ 7 cm); Presence of measurable lesions; Meeting any of the following criteria:; B symptoms: unexplained fever >38°C, night sweats, unexplained weight loss >10% in the last 6 months; Abnormal signs: splenomegaly, pleural effusion, ascites, etc; Major organ damage: involvement of major organs leading to organ dysfunction; Hematologic involvement: cytopenia [WBC < 1.0 × 10⁹/L and/or PLT < 100 × 10⁹/L]; leukemia-like manifestations (malignant cells > 5.0 × 10⁹/L); elevated LDH levels; HGB < 120 g/L; β2-microglobulin ≥ 3 mg/L; Bulky disease: involvement of ≥ 3 tumors with each diameter ≥ 3 cm, or any lymph node or extranodal tumor with diameter ≥ 7 cm (for Ann Arbor stage III-IV patients); Tumor enlargement of 20%-30% within 2-3 months, or approximately 50% enlargement within 6 months; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; Expected survival of > 6 months.

Exclusion: History of allergy to any component of monoclonal antibodies or investigational drugs; Infection requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to enrollment; or infection requiring oral antibiotics within 2 weeks prior to enrollment; or symptoms related to an infection within 1 week prior to enrollment; Major surgery within 4 weeks prior to enrollment; Vaccination with live vaccines within 4 weeks prior to enrollment or planned live vaccination during the study; Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test result exceeding the detection limit; Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, with Hepatitis B virus DNA quantitative test result exceeding the detection limit (for patients with HBsAg or HBcAb positive status, regardless of HBV-DNA detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial); History of previous malignant tumors; Clinically significant cardiac or pulmonary diseases; HIV antibody positive; Active syphilis infection, TP antibody positive, and anti-TP treatment within the last 2 years; Central nervous system involvement; Pregnant or breastfeeding women, or planning to become pregnant during the study; Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.

ClinicalTrials.gov NCT06757894