Efficacy and Safety of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL

Официальное название

A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

Обзор

The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (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 Prednisone
  Prednisone PO will be administered as per the schedule specified in the respective arm.
• Препарат Zanubrutinib
  Zanubrutinib PO will be administered as per the schedule specified in the respective arm.
• Препарат Lenalidomide
  Lenalidomide PO will be administered as per the schedule specified in the respective arm.
• Препарат Decitabine
  Decitabine IV infusion will be administered as per the schedule specified in the respective arm.

Первичные конечные точки

• Progression-free survival（by IRC） [Срок оценки: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)]

Вторичные конечные точки (6)

• Progression-free survival（by the investigator） [Срок оценки: From randomization to the first occurrence of disease progression or relapse, or death from any cause, whichever occurs earlier (up to 24 months)]
• Event-free survival [Срок оценки: up to approximately 24 months]
• Complete response rate [Срок оценки: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]]
• Objective response rate [Срок оценки: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]]
• Overall survival [Срок оценки: up to approximately 3 years]
• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [Срок оценки: From enrollment to study completion, a maximum of 3 years]

Критерии участия

Критерии включения

• Signed Informed Consent Form
• Age 18-75 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
• Previously untreated participants with CD20-positive DLBCL
• IPI score 2-5
• ECOG Performance Status of 0, 1, or 2
• After 1 cycle of Pola-R-CHP, ctDNA decreased by < 3.0 LFC
• Life expectancy ≥ 6 months
• 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 Zanubrutinib/Lenalidomide/ Decitabine
• Prior solid organ transplantation or SCT
• Current diagnosis of the following: Follicular lymphoma grade 3B; mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; PCNSL
• 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 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 < 30 mL/min (using Cockcroft-Gault formula)
• Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
• Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology)：Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HbsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing every month and appropriate antiviral therapy as indicated
• Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing)：Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA
• Participants with a history of progressive multifocal leukoencephalopathy
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 months after final dose of Pola-RCHP-X
• Other concurrent and uncontrolled medical conditions that, in the opinion of the investigator, would affect the patient's participation in the study

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

Китай · 1 центр

• Ruijin Hospital, Shanghai JiaoTong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT06803693 · GUIDANCE05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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