Real-World Study of Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Glofitamab.
- Кому может быть актуально
- Состояния в реестре: Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Real-World Study on the Efficacy and Safety of Bispecific Antibody in the Treatment of Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Обзор
B-cell non-Hodgkin lymphoma (B-NHL) is the most common type of lymphoma. Although first-line R-CHOP can cure a proportion of patients, approximately 30%-40% relapse or become refractory (R/R). CD20xCD3 bispecific antibodies, represented by glofitamab, have shown significant efficacy in clinical trials. However, large-scale real-world efficacy and safety data in Chinese clinical practice are still lacking, particularly regarding combination with different regimens and use in the relapsed population. This is a prospective, multicenter, observational registry study evaluating the efficacy and safety of CD20xCD3 bispecific antibody-containing regimens in patients with relapsed or refractory B-cell non-Hodgkin lymphoma in a real-world setting. Efficacy is assessed using the Lugano 2014 response criteria. The primary endpoint is best objective response rate (ORR).
Подробное описание
Study design: Prospective, multicenter, observational (non-interventional) registry study.
Population: Patients aged \>=18 years with histologically confirmed B-cell non-Hodgkin lymphoma who are relapsed or refractory after at least one prior line of therapy and who receive a CD20xCD3 bispecific antibody-containing regimen after study initiation.
Efficacy evaluation: Lugano 2014 response criteria.
Primary endpoint: Best objective response rate (ORR).
Secondary endpoints: Complete response rate (CRR), disease control rate (DCR), duration of response (DOR), time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), and safety.
Exploratory endpoints: Subgroup analyses by combination pattern (e.g., combined with chemotherapy or targeted agents) and special populations; correlation of biomarkers (e.g., peripheral blood lymphocyte subsets, T-lymphocyte mitochondrial immune analysis, cytokines) with efficacy and safety; and patient compliance and quality-of-life analyses based on electronic patient-reported outcomes (ePRO).
Planned enrollment: 200 participants. As a non-interventional study, no formal statistical hypothesis is tested; the sample size is based on the confidence-interval width method (expected ORR P=0.5, half-width d=0.07), yielding approximately 196 participants, rounded to 200.
Вмешательства
- Биопрепарат Glofitamab
Glofitamab, a CD20xCD3 bispecific monoclonal antibody, administered per real-world clinical practice and product labeling. As an observational study, treatment is determined by the treating physician and not by the study protocol; the intervention of interest is recorded to describe the treated population.
Первичные конечные точки
- Best Overall Response Rate (ORR) [Срок оценки: From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years]
Вторичные конечные точки (7)
- Disease Control Rate (DCR) [Срок оценки: From treatment initiation until disease progression, assessed up to approximately 2 years]
- Duration of Response (DOR) [Срок оценки: From first response until disease progression or death, assessed up to approximately 2 years]
- Time to Next Treatment (TTNT) [Срок оценки: From treatment initiation until start of next therapy or death, assessed up to approximately 2 years]
- Progression-Free Survival (PFS) [Срок оценки: From treatment initiation until disease progression or death, assessed up to approximately 2 years]
- Overall Survival (OS) [Срок оценки: From treatment initiation until death from any cause, assessed up to approximately 2 years]
- Incidence of Adverse Events (Safety) [Срок оценки: From treatment initiation until 90 days after last dose, assessed up to approximately 2 years]
- Complete Response Rate (CRR) [Срок оценки: From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years]
Критерии участия
Критерии включения
- Age >= 18 years at the start of treatment
- Histologically confirmed B-cell non-Hodgkin lymphoma
- Relapsed or refractory disease after at least one prior line of systemic therapy
- Planned to receive a CD20xCD3 bispecific antibody-containing regimen after study initiation
- Signed informed consent for the investigational treatment
Критерии исключения
- Currently participating in, or planning to participate in, any interventional clinical trial
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- Henan Cancer Hospital — Чжэнчжоу
Идентификаторы
NCT: NCT07695896 · HNSZLYYNHL12 · 2026-254