Efficacy and Safety of Zuberitamab Combined with Bendamustine, Followed by Monotherapy Maintenance, in Treatment-naïve Follicular Lymphoma

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Zuberitamab
  375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6)
• Препарат Bendamustine
  90 mg/m², administered on D1-2 of C1-C6

Первичные конечные точки

• Complete Response (CR) [Срок оценки: Up to 6 cycles (each cycle is 28 days).]

Вторичные конечные точки (7)

• Objective Response Rate (ORR) [Срок оценки: Up to 6 cycles (each cycle is 28 days).]
• Progression-Free Survival (PFS) [Срок оценки: From the start of induction therapy to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 78 months.]
• Event-Free Survival (EFS) [Срок оценки: From the start of induction therapy to the first occurrence of any event, including disease progression, discontinuation of treatment, or death for any reason, whichever occurs first, assessed up to 78 months.]
• Duration of Response (DOR) [Срок оценки: From the first documentation of CR or PR to the first documented disease progression, assessed up to 78 months.]
• Overall Survival (OS) [Срок оценки: From the start of induction therapy to death from any cause, assessed up to 78 months.]
• Time to Next Treatment (TTNT) [Срок оценки: From the start of induction therapy to the start of the next line of anti-tumor treatment, assessed up to 78 months.]
• Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE) [Срок оценки: From the start of induction therapy through the end of the maintenance therapy phase, up to 30 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• History of allergy to any component of monoclonal antibodies or investigational drugs.
• Central nervous system involvement.
• History of previous malignant tumors.
• Clinically significant cardiac or pulmonary diseases.
• 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.
• HIV antibody positive.
• Active syphilis infection, TP antibody positive, and anti-TP treatment within the last 2 years.
• 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).
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University — Гуанчжоу

Идентификаторы

NCT: NCT06757894 · B2024-815-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗