Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Официальное название

Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients in Treatment of Newly Diagnosed Untreated Non-GCB DLBCL With Extranodal Involvement.

Обзор

Aim of this study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.

Подробное описание

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. The POLARIX study also observed an benefit in the efficacy of Polatuzumab Vedotin in first-line treatment of DLBCL patients. This study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.

Вмешательства

• Препарат Polatuzumab Vedotin
  1.8mg/kg/21d（d0） Intravenous infusion
• Препарат Zanubrutinib
  160mg bid PO（d0-d20）
• Препарат Rituximab
  375mg/㎡/21d（d0） Intravenous infusion
• Препарат Cyclophosphamide
  750mg/㎡/21d（d1） Intravenous infusion
• Препарат Doxorubicin
  50mg/㎡/21d（d1） Intravenous infusion
• Препарат Prednisone
  100mg PO （d1-d5）/21d

Первичные конечные точки

• Progression-free Survival（PFS） [Срок оценки: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.]

Вторичные конечные точки (5)

• Objective Response rate（ORR） [Срок оценки: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.]
• Complete Response（CR） [Срок оценки: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.]
• Duration of Response（DOR） [Срок оценки: All time in the study]
• Overall Survival [Срок оценки: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.]
• Adverse Events(AEs) [Срок оценки: From date of enrollment until the date follow up for 2 years after the treatment or progression disease or date of death for any cause.]

Критерии участия

Критерии включения

• Histologically confirmed Non-GCB DLBCL with extrinsic involvement；
• Measurable disease of at least 15mm(node)/10mm（extranodal）；
• ECOG performance status 0-2；
• Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN；
• Adequate bone marrow function:Platelet count (≥ 50×10\^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10\^9/L)
• Estimated survival time ≥3 months
• Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study.

Критерии исключения

• Accepted major surgery within 4 weeks before treatment;
• Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
• Previous history of indolent lymphoma;
• Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ;
• History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
• Requires treatment with a strong/medium CYP3A inducer;
• The previous use of anthracycline-based drugs > 150 mg/m2;
• Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease;
• HIV infection and/or active hepatitis B or active hepatitis C;
• Uncontrolled systemic infection;
• Pregnant or breasting-feeding women;
• According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Soochow University — Сучжоу

Идентификаторы

NCT: NCT06468943 · Pola-ZR-CHP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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