Zanubrutinib, Rituximab, and Lenalidomide in the First-Line Treatment of Marginal Zone Lymphoma

Официальное название

A Multicenter, Single-Arm, Prospective Clinical Study of Zanubrutinib, Rituximab, and Lenalidomide in the First-Line Treatment of Marginal Zone Lymphoma

Обзор

The goal of this clinical trial is to learn if Zanubrutinib, Rituximab, and Lenalidomide works to treat marginal zone lymphoma as the first-line therapy. It will also learn about the safety of the treatment. The main questions it aims to answer are Does the combined therapy prolong patient survival? What medical problems do participants have when using this therapeutic approach? Researchers will observe the treatment to see if it works well than conventional therapies. Participants will Administer drugs as required by the protocol Visit the clinic regularly for checkups and tests Keep a diary of their symptoms, examination and laboratory test indicators

Вмешательства

• Препарат Zanubrutinib, Rituximab, and Lenalidomide as first-line treatment for Marginal Zone Lymphoma
  This study enrolls patients with marginal zone lymphoma who require the primary treatment. Participants receive a combined therapy consisting of zanubrutinib, rituximab, and lenalidomide.
• Препарат Zanubrutinib, Rituximab, and Lenalidomide as the primary treatment for Marginal Zone Lymphoma
  This study enrolls patients with marginal zone lymphoma who require the primary treatment. Participants receive a combined therapy consisting of zanubrutinib, rituximab, and lenalidomide.

Первичные конечные точки

• CRR [Срок оценки: 2 years]

Вторичные конечные точки (6)

• ORR [Срок оценки: 2 years]
• 2 year-progress free survival rate [Срок оценки: 2 years]
• TTR [Срок оценки: From randomization up to 24 months post-randomization]
• DoR [Срок оценки: From the date of first confirmed CR/PR up to 24 months post-confirmed response]
• OS [Срок оценки: From randomization up to 24 months post-randomization]
• Incidence rate of adverse events [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 18-75 years
• Histologically confirmed MZL in untreated stage III or IV and needed for therapy as determined by the treating physician
• ECOG performance status 0-2
• Expected survival ≥ 6 months
• Adequate hematologic and organ function: absolute neutrophil count ≥1,000/mm3 (independent of growth factor support), platelet counts ≥75,000/mm3, serum aspartate transaminase or alanine transaminase less than 2.5 times the upper limit of normal (ULN), serum creatinine ≤1.5×ULN, and bilirubin ≤1.5×ULN unless bilirubin is due to Gilbert's syndrome, documented liver involvement with lymphoma, or of nonhepatic origin, in which case bilirubin should not exceed 3 g/dL, left ventricular ejection fraction (LVEF) of the heart≥ 50%
• Women of childbearing potential and men who were sexually active were required to be practicing a highly effective method of birth control during and after the study
• No history of other malignant tumors
• At least one measurable lesion with a longest diameter of ≥ 1.5 cm or measurable lesions of extranodal lesions ≥ 1.0 cm.
• Able to understand the study and provide signed Informed Consent Form

Критерии исключения

• Pregnant or lactating women
• Active central nervous system lymphoma
• Previous anti-tumor treatment
• A severe immediate-type hypersensitivity reaction history for any of the drugs used in this study
• History of stroke or intracranial hemorrhage within 6 months before study entry
• Received a live attenuated vaccine within 4 weeks prior to enrollment History of human immunodeficiency virus, or active hepatitis C virus, or active hepatitis B virus infection, or any uncontrolled active systemic infection
• 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 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
• Other serious medical conditions that might have an impact on this study

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07299331 · 2025-KY-1174-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗