Real-World Study of Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
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
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).
Обзор исследования
Статус
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Yanyan Liu
- Номер телефона: +86 13838176375
- Электронная почта: yyliu@zzu.edu.cn
Места учебы
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Henan
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Zhengzhou, Henan, Китай
- Henan Cancer Hospital
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Контакт:
- Yanyan Liu
- Номер телефона: +86 13838176375
- Электронная почта: yyliu@zzu.edu.cn
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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R/R B-NHL treated with bispecific antibody
Patients with relapsed or refractory B-cell non-Hodgkin lymphoma who receive a CD20xCD3 bispecific antibody-containing regimen (e.g., glofitamab) in routine clinical practice.
This is a single observational cohort; no treatment is assigned by the study.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Best Overall Response Rate (ORR)
Временное ограничение: From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years
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ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to the Lugano 2014 response criteria for malignant lymphoma.
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From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Disease Control Rate (DCR)
Временное ограничение: From treatment initiation until disease progression, assessed up to approximately 2 years
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DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) per Lugano 2014 criteria.
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From treatment initiation until disease progression, assessed up to approximately 2 years
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Duration of Response (DOR)
Временное ограничение: From first response until disease progression or death, assessed up to approximately 2 years
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DOR is defined as the time from the first documented CR or PR to the first documented disease progression or death from any cause, whichever occurs first, among responders.
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From first response until disease progression or death, assessed up to approximately 2 years
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Time to Next Treatment (TTNT)
Временное ограничение: From treatment initiation until start of next therapy or death, assessed up to approximately 2 years
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TTNT is defined as the time from treatment initiation to the start of the next line of anti-lymphoma therapy or death from any cause, whichever occurs first.
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From treatment initiation until start of next therapy or death, assessed up to approximately 2 years
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Progression-Free Survival (PFS)
Временное ограничение: From treatment initiation until disease progression or death, assessed up to approximately 2 years
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PFS is defined as the time from treatment initiation to the first documented disease progression per Lugano 2014 criteria or death from any cause, whichever occurs first.
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From treatment initiation until disease progression or death, assessed up to approximately 2 years
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Overall Survival (OS)
Временное ограничение: From treatment initiation until death from any cause, assessed up to approximately 2 years
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OS is defined as the time from treatment initiation to death from any cause.
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From treatment initiation until death from any cause, assessed up to approximately 2 years
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Incidence of Adverse Events (Safety)
Временное ограничение: From treatment initiation until 90 days after last dose, assessed up to approximately 2 years
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Safety is assessed by the incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs), including adverse events of special interest such as cytokine release syndrome (CRS), graded per NCI CTCAE and, for CRS, per ASTCT consensus criteria.
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From treatment initiation until 90 days after last dose, assessed up to approximately 2 years
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Complete Response Rate (CRR)
Временное ограничение: From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years
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CRR is defined as the proportion of participants achieving a best overall response of complete response (CR) per Lugano 2014 criteria.
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From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Yanyan Liu, Henan Cancer Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Патологические процессы
- Новообразования
- Атрибуты болезни
- Заболевания иммунной системы
- Новообразования по гистологическому типу
- Лимфатические заболевания
- Лимфопролиферативные заболевания
- Иммунопролиферативные заболевания
- Лимфома, неходжкинская
- Лимфома
- Патологические состояния, признаки и симптомы
- Гемики и лимфатические заболевания
- Повторение
- Лимфома, В-клеточная
- Глофитамаб
Другие идентификационные номера исследования
- HNSZLYYNHL12
- 2026-254 (Другой идентификатор: Henan Cancer Hospital Medical Ethics Committee)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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