Study on the Treatment of Double/Triple-hit DLBCL With Chidamide and Lisaftoclax in Combination With Pola-R-CHP

Официальное название

Study on the Treatment of Double/Triple-hit Diffuse Large B-cell Lymphoma With Chidamide and Lisaftoclax in Combination With Vepesidil, Rituximab, Cyclophosphamide, Adriamycin, and Prednisone (CL-Pola-R-CHP)

Обзор

This is an open-label, multicenter clinical study for patients aged 65 and above with double/triple-hit diffuse large B-cell lymphoma who are not suitable for transplantation. The study employs a 6-cycle CL-Pola-R-CHP regimen, with cycles repeated every 21 days.

Вмешательства

• Препарат CL-Pola-R-CHP
  R 375 mg/m2 D1 Pola 1.8mg/kg D1 CTX 750mg/m2 D2 ADR 50mg/m2 D2 Pred 60 mg/m2 D2-6 Chidamide 20mg/d D1,4,8,11 Lisaftoclax 600mg/d D1-21

Первичные конечные точки

• Complete remission (CR) rate [Срок оценки: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]]

Вторичные конечные точки (2)

• 1-year progression-free survival (PFS) rate [Срок оценки: 1 years after enrollment]
• 2-year overall survival (OS) rate [Срок оценки: 2 years after enrollment]

Критерии участия

Критерии включения

• Histopathological diagnosis confirmed as diffuse large B-cell lymphoma, with CD20 positivity;
• Double or triple hit confirmed by pathology;
• Age ≥ 65 years old;
• ECOG performance status score of 0, 1, or 2;
• No history of malignant tumor; no concurrent occurrence of other tumors;
• Patients whose life expectancy is at least 6 months, as determined by the researcher;
• The patient or their legal guardian must provide written informed consent before undergoing any special examinations or procedures in the study.
• International Prognostic Index (IPI) > 1 point.

Критерии исключения

• There is a history of other malignant tumors, excluding basal cell carcinoma and cervical carcinoma in situ;
• Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc;
• Primary central nervous system lymphoma;
• Left ventricular ejection fraction (LVEF) is less than or equal to 50%;
• Laboratory test values during screening: (unless caused by lymphoma); A. Neutrophil count <1.5\*10\^9/L; B. Platelet count <75\*10\^9/L; C. ALT or AST is more than twice the upper limit of normal, and AKP and bilirubin are more than 1.5 times the upper limit of normal; D. Creatinine level is higher than 1.5 times the upper limit of normal;
• Other concurrent and uncontrolled medical conditions that the researcher believes will affect the patient's participation in the study.
• Patients with mental illness or other patients known or suspected to be unable to fully comply with the study protocol;
• Pregnant or lactating women;
• HIV-infected individuals.
• Patients with positive HBsAg test results must undergo HBV DNA testing and can only be enrolled after becoming negative. Additionally, if the HBsAg test result is negative but the HBcAb test result is positive (regardless of the HBsAb status), HBV DNA testing is also required. If the result is positive, treatment must be administered until becoming negative before enrollment;

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07552324 · CL-Pola-R-CHP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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