A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL

Официальное название

A Prospective, Open-Label, Multicenter, Randomized Controlled Study Comparing the Efficacy and Safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Combined With Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

Обзор

This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL.

Вмешательства

• Препарат Polatuzumab vedotin
  Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
• Препарат Rituximab
  Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
• Препарат Cyclophosphamide
  Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
• Препарат Doxorubicin
  Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
• Препарат Vincristine
  Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
• Препарат Prednisone
  Prednisone PO will be administered as per the schedule specified in the respective arm.
• Препарат Orelabrutinib
  Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
• Препарат Venetoclax
  Venetoclax PO will be administered as per the schedule specified in the respective arm.
• Препарат Chidamide
  Chidamide PO will be administered as per the schedule specified in the respective arm.
• Препарат Penpulimab
  Penpulimab IV infusion will be administered as per the schedule specified in the respective arm.

Первичные конечные точки

• Progression Free Survival at 24 months (PFS24) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: At 24 months]

Вторичные конечные точки (5)

• Complete Response Rate (CRR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days]]
• Overall Response Rate (ORR) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 8 [Cycle length=21 days]]
• Event Free Survival (EFS) Assessed by Investigator per Lugano Response Criteria for Malignant Lymphoma [Срок оценки: up to approximately 48 months]
• Overall Survival (OS) [Срок оценки: up to approximately 48 months]
• Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From enrollment to study completion, a maximum of 48 months]

Критерии участия

Критерии включения

• Sign the informed consent form
• Previously untreated participants with CD20-positive DLBCL
• Life expectancy ≥ 6 months
• IPI score 2-5
• ECOG Performance Status of 0, 1, or 2
• Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
• Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to involvement of the spleen by DLBCL per the investigator for which blood product transfusions are permitted) defined as follows:

Hemoglobin ≥ 9.0 g/dL without packed RBC transfusion during 7 days before first treatment ANC ≥ 1.0 x 10\^9/L PLT ≥ 75 x 10\^9/L

Критерии исключения

• Contraindication to any of the individual components of Pola-RCHP or Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1
• History of other malignancy that could affect compliance with the protocol or interpretation of results
• Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina
• History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
• Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
• Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):

Serum AST and ALT ≥ 2.5 x ULN Total bilirubin ≥ 1.5 x ULN Serum creatinine clearance < 40 mL/min (using Cockcroft-Gault formula)

• Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
• Participants with a history of progressive multifocal leukoencephalopathy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06516978 · 2024-SR-436

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗