The Efficacy and Safety of Pola-ZR-Glo in Older Treatment-naive Patients With LBCL

Официальное название

The Efficacy and Safety of Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) Regimen in Older Treatment-naive Patients With Large B-cell Lymphoma (LBCL)

Обзор

This is a prospective, single-center, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen in older treatment-naive patients with large B-cell lymphoma.

Вмешательства

• Препарат Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen
  Pola-ZR-Glo (Polatuzumab Vedotin, Zanubrutinib, Lenalidomide and Glofitamab) regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 12 cycles. Dosage: Polatuzumab vedotin (1.8 mg/kg) will be administered intravenously on Day 2 of Cycle 1 and on Day 1 of Cycles 2-6 (each Q3W). Zanubrutinib (160mg bid p.o.) will be administered from D1 to D21 through Cycles 1-6 Q3W. Lenalidomide (25mg qd p.o.) will be administered fro

Первичные конечные точки

• Progression free survival [Срок оценки: Baseline up to data cut-off (up to approximately 2 years)]

Вторичные конечные точки (7)

• Event-free survival [Срок оценки: Baseline up to data cut-off (up to approximately 2 years)]
• Complete response rate [Срок оценки: At the end of Cycle 3, 6 and at the end of treatment (each cycle is 21 days)]
• Objective response rate [Срок оценки: At the end of Cycle 3, 6 and at the end of treatment (each cycle is 21 days)]
• Overall Survival [Срок оценки: Baseline up to data cut-off (up to approximately 2 years)]
• DoR [Срок оценки: From documentation of CR/PR until relapse/progression or death due to any reason without documented relapse, whichever came first, assessed up to 32 months.]
• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v6.0 [Срок оценки: From enrollment to study completion, a maximum of 4 years]
• Patient reported outcome [Срок оценки: Day 1 of Cycles 1, 4 and 7 (Cycle length=21 days); 30 days after treatment completion]

Критерии участия

Критерии включения

Patients must satisfy all of the following criteria to be enrolled in the study:

• Histologically-confirmed large B-cell lymphoma (without central nervous system involvement)
• Aged ≥ 70 years old with comprehensive geriatric assessment stratified as unfit or frail, or those who decline immunochemotherapy.
• Eastern Cooperative Oncology Group Performance Status 0-2
• At least 1 measurable site of disease (defined as lymph nodes with the long diameters longer than 1.5cm, or extra-nodal sites with the long diameters longer than 1.0cm; meanwhile, any lesion site with at least 2 measurable vertical diameters)
• Life expectancy of at least 3 months determined by researchers
• The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research.
• Anti-lymphoma drugs have not been used before (except glucocorticoids)

Критерии исключения

Presence of any of the following criteria will exclude a patient from enrollment:

• Uncontrolled blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
• Laboratory measures meet the following criteria at screening (unless caused by lymphoma):

Neutrophils<1.0×10\^9/L Platelets<75×10\^9/L ALT or AST is 2.5 times higher than the upper limits of normal (ULN), serum bilirubin are 1.5 times higher than the ULN.

eGFR is lower than 30ml/min/1.73m\^2 (according to Cockcroft-Gault Equation or MDRD Equation).

• uncontrollable or significant cardiovascular diseases, including but not limited to: Left ventricular ejection fraction<50% Cardiomyopathy, such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy QTc prolongation with clinical significance, QTc interval>470ms (females) or 480ms (males), type 2 second-degree atrioventricular block or third-degree atrioventricular block
• Patients with HbsAg positive are required to have HBV DNA<1.0×10\^3 IU/ml before entering the group. In addition, if the patient is HBsAg negative but HBcAb positive (regardless of HBsAb status), HBV DNA test is also required, and HBV DNA<1.0×10\^3 IU/ml is required before entering the group
• Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
• HIV-infected patients
• History of stroke or intracranial hemorrhage within 6 months prior to start of therapy
• Other medical conditions determined by the researchers that may affect the study

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

• Ruijin Hospital — Шанхай

Идентификаторы

NCT: NCT07514169 · SILVERGLO

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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