Zanubrutinib-based Maintenance Therapy of Newly Diagnosed DLBCL With Initial Remission

Официальное название

The Efficacy and Safety of Zanubutinib-based for Post-remission Maintenance in Patients With Diffuse Large B-cell Lymphoma Who Are Intolerant to Intense First-line Chemotherapy

Обзор

This single-arm, prospective clinical study will evaluate the efficacy and safety of Zanubrutinib-based maintenance therapy for post-remission in newly diagnosed DLBCL who are intolerant to first-line intensive chemotherapy.

Вмешательства

• Препарат Zanubrutinib
  160 mg bid, po, day 1-21, a maximum of 2 years.
• Препарат Lenalidomide
  25 mg qd, po, day 1-10, a maximum of 2 years.

Первичные конечные точки

• 2-year recurrence-free survival [Срок оценки: 2 years after enrollment]

Вторичные конечные точки (3)

• Overall survival [Срок оценки: From enrollment to study completion, a maximum of 4.5 years]
• Overall response rate [Срок оценки: up to 2 year, at the end of maintenance]
• Complete response rate [Срок оценки: up to 2 year, at the end of maintenance]

Критерии участия

Критерии включения

• Patients were informed about this study and voluntarily signed written informed consent
• Patients were intolerant first-line intensive chemotherapy, including R-CHOP or R-DA-EPOCH: a) age≧70 years, or unfit or frail according to CGA; b) ECOG 0-2; c) measurable lesions
• DLBCL with initial CR/PR according to 2016 WHO Classification of Tumor of Haematopoietic and Lymphoid Tissues
• Life expectancy > 3 months
• Normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /L independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (BM) involvement independent of transfusion support in either situation Normal organ functions defined as: creatinine ≤1.5 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) ≥50 ml/min/1.73m 2 , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN;
• Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. - Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[Beta-hCG\]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.

Критерии исключения

• Contraindication to any drug in the study
• Seropositive for or active viral infection with HBV or HCV
• Human immunodeficiency virus (HIV) infection
• Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional class;
• QTc (corrected by Fridericia formula): >480ms;
• Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix
• If female, the patient is pregnant or breast-feeding
• Any uncontrolled active systemic infection

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: NCT06669143 · zanubrutinib-based maintenance

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗