Набор скоро начнётся NCT06656234

The Effectiveness and Safety of Glofitamab in Real-World Clinical Practice Among Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter Study

— Наблюдательное Diffuse Large B Cell Lymphoma (DLBCL)

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, Obinutuzumab.
Кому может быть актуально: Состояния в реестре: Diffuse Large B Cell Lymphoma (DLBCL). 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 →

The purpose of this study is to evaluate the the efficacy and safety in the real-world settings of glofitamab among Chinese R/R DLBCL participants.

Препарат Glofitamab
Glofitamab will be administered at the discretion of the physician per local clinical practice and local labeling.
Препарат Obinutuzumab
Obinutuzumab pre-treatment is given intravenously at a dose of 1g on Cycle 1 Day 1.

Progression free survival (PFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: Baseline up to end of study (EOS) (approximately 48 months)]

Вторичные конечные точки (6)

Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: Baseline up to EOS (approximately 48 months)]
Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: Baseline up to EOS (approximately 48 months)]
Duration of Response (DoR) [Срок оценки: From the date of the first occurrence of a documented CR or partial response (PR) to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months)]
Duration of Complete Response (DoCR) [Срок оценки: From the date of the first occurrence of a documented CR to the date of progression, relapse, or death from any cause, whichever occurs first (up to approximately 48 months)]
Time to Next Treatment (TTNT) [Срок оценки: From the start of glofitamab treatment to the initiation of next-line treatment (up to approximately 48 months)]
Overall Survival (OS) [Срок оценки: From the start of glofitamab treatment until the date of death from any cause (up to approximately 48 months)]

Be diagnosed as R/R DLBCL
Participants who will be treated with glofitamab (known as being recommended and having the intention to be treated with glofitamab at the time of signing informed consent) or have initiated glofitamab treatment within 6 months prior to enrollment and after the indication approval will be observed in this study.