Zanubrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL

Официальное название

A Single-center, Randomized Controlled Clinical Study of Zanubrutinib Combined With Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preconditioning Regimen for ASCT in Relapsed and Refractory DLBCL

Обзор

This trial is a prospective, single-center, randomized controlled clinical research. The intention is to evaluate the efficacy and safety of zanubrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients through prospective clinical studies.

Подробное описание

This trial includes 66 patients with recurrent or refractory DLBCL, who will be randomly divided into a 1:1 combination of zanubrutinib and BEAM regimen pretreatment (experimental group) or a standard BEAM regimen pretreatment (control group), and then undergo ASCT treatment. The entire trial includes a screening period (before the start of autologous stem cell transplantation pretreatment), a treatment period (-8 days to -2 days, a total of 7 days), and a follow-up period (2 years after autologous stem cell transplantation)

Вмешательства

• Препарат zanubrutinib combined with BEAM
  zanubrutinib：160mg oral bid D-8-D-2 camustine: 300mg/m2 vgtt qd D-8 etoposide: 100mg/m2/d vgtt q12h D-7-D-4 cytarabine: 200mg/m2/d vgtt q12h D-7-D-4 melphalan: 140mg/m2 vgtt qd D3-D-2
• Препарат BEAM
  camustine: 300mg/m2 vgtt qd D-8 etoposide: 100mg/m2/d vgtt q12h D-7-D-4 cytarabine: 200mg/m2/d vgtt q12h D-7-D-4 melphalan: 140mg/m2 vgtt qd D3-D-2

Первичные конечные точки

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

Вторичные конечные точки (4)

• Overall survival [Срок оценки: Baseline up to data cut-off (up to approxiamately 2 years)]
• Complete remission rate [Срок оценки: 3 months after the transplantation]
• The time of hematopoietic reconstruction [Срок оценки: 2 months after the transplantation]
• Transplantation-related adverse reactions [Срок оценки: Baseline up to data cut-off (up to approxiamately 4 years)]

Критерии участия

Критерии включения

• According to world Health Organization (WHO) classification of disease, diffuse large B-cell lymphoma was confirmed by histology, CR or PR after second-line and above treatment;
• 18≤ age ≤65 years old, male or female;
• ECOG score 0-2;
• No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) :

• White blood cell count ≥3.0×109/L, absolute neutrophil count ≥1.5×109/L, Hemoglobin ≥90g/L, platelet ≥75×109/L;
• Total bilirubin ≤1.5× upper normal value (ULN);
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× ULN; Bilirubin ≤1.5× ULN
• Creatinine clearance was 44-133 mmol/L;
• No cardiac dysfunction;
• Life expectancy over 3 months;
• The subject or his/her legal representative must provide written informed consent prior to conducting a special study examination or procedure.

Критерии исключения

• Previously received autologous hematopoietic stem cell transplantation;
• Suffering from serious complications or severe infection;
• Previous treatment with selinexor;
• Central nervous system lymphoma was excluded;
• A history of other malignant tumors within 5 years, excluding early tumors treated for curative purposes;
• Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.;
• HBsAg, HCV or HIV positive. Positive HBV and HCV serology is allowed, but DNA/RNA testing must be negative;
• Left ventricular ejection fraction ≦ 50%;
• Laboratory test value during screening;

① Neutrophils <1.5×109/L; Platelet <75×109/L;

② Bilirubin was 1.5 times higher than the normal upper limit, transaminase was 2.5 times higher than the normal upper limit;

③ The creatinine level is higher than 1.5 times the upper limit of normal value;

• Other concurrent and uncontrolled medical conditions considered by the investigator would affect the patient's participation in the study;
• Psychiatric patients or other patients known or suspected to be unable to fully comply with the study protocol;
• Pregnant or lactating women;
• The researcher judged that the patients were not suitable for this 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

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06652165 · ASCT-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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