A Study to Evaluate the Effectiveness and Safety of Polatuzumab in Real World Clinical Practice Among Adult Chinese Participants With Diffuse Large B-Cell Lymphoma

Официальное название

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

Обзор

The purpose of this study is to assess the progression free survival (PFS) in the real-world settings of polatuzumab among Chinese diffuse large B cell lymphoma (DLBCL) participants.

Вмешательства

• Препарат Polatuzumab Vedotin
  Polatuzumab vedotin will be administered at the discretion of the physician per local clinical practice and local labeling.

Первичные конечные точки

• Cohorts 1 and 2: Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: At 24 months]
• Cohort 3: PFS Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: Baseline up to end of study (EOS) (approximately 38 months)]

Вторичные конечные точки (10)

• Cohort 3: PFS24 Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: At 24 months]
• Cohorts 1, 2 and 3: Time to Next Treatment (TTNT) [Срок оценки: From the start of polatuzumab treatment to the initiation of next-line treatment (up to approximately 38 months)]
• Cohorts 1, 2 and 3: Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: Baseline up to EOS (approximately 38 months)]
• Cohorts 1, 2 and 3: Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: Baseline up to EOS (approximately 38 months)]
• Cohorts 1 and 2: Disease Control Rate (DCR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: Baseline up to EOS (approximately 38 months)]
• Cohorts 1, 2 and 3: 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 38 months)]
• Cohorts 1 and 2: Disease Free Survival (DFS) [Срок оценки: From the date of the first occurrence of a documented CR, to the date of relapse or death from any cause, whichever occurs first (up to approximately 38 months)]
• Cohorts 1 and 2: Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: From the start of polatuzumab treatment to any treatment failure including disease progression, relapse, initiation of new antilymphoma therapy (NALT), or death from any cause, which occurs first (up to approximately 38 months)]
• Cohorts 1, 2 and 3: Overall Survival (OS) [Срок оценки: From the start of polatuzumab treatment until the date of death from any cause (up to approximately 38 months)]
• Cohorts 1, 2 and 3: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) [Срок оценки: Up to EOS (approximately 38 months)]

Критерии участия

Критерии включения

• Be diagnosed as DLBCL
• Cohort 1: diagnosed as unfit/frail DLBCL. The unfit/frail is defined as aged 80 years or older, or younger than 80 years but with comorbidity and not tolerant to the standardized dose of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy according to investigator's judgment
• Cohort 2: diagnosis as DLBCL but could not be classified into unfit/frail
• Cohort 3: relapse or refractory to previous treatment

Критерии исключения

• Participant who currently participates in or with plan to participate in any interventional clinical trial
• Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate 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 · 29 центров

• Peking Union Medical College Hospital — Пекин
• Peking University Third Hospital — Пекин
• Beijing Hospital of Ministry of Health — Пекин
• Beijing Tongren Hospital, Capital Medical University — Пекин
• The First Bethune Hospital of Jilin University — Changchun
• Xiangya Hospital of Centre-South University — Чанша
• Third Xiangya Hospital of Central South University — Чанша
• Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Чэнду
• … и ещё 21 центр

Идентификаторы

NCT: NCT05954910 · ML44616

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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