Набор скоро начнётся NCT07622784
Pirtobrutinib Maintenance After CAR-T Therapy in Relapsed or Refractory B-Cell Lymphoma
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Pirtobrutinib, Second Infusion of Commercial Anti-CD19 CAR-T Cells.
- Кому может быть актуально
- Состояния в реестре: Relapsed or Refractory B-cell Lymphoma. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Single-Arm, Open-Label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Pirtobrutinib as Maintenance Therapy for Relapsed or Refractory B-Cell Lymphoma After CAR-T Cell Therapy
Обзор
This is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of pirtobrutinib as maintenance therapy in patients with relapsed or refractory B-cell lymphoma after commercial anti-CD19 CAR-T cell therapy.
Вмешательства
- Препарат Pirtobrutinib
Pirtobrutinib will be administered orally at a dose of 200 mg once daily for 6 months, beginning on Day 30 after commercial anti-CD19 CAR-T cell infusion. Dose interruption, dose reduction, or treatment discontinuation will be performed according to protocol-specified toxicity management rules. - Биопрепарат Second Infusion of Commercial Anti-CD19 CAR-T Cells
A second infusion of commercial anti-CD19 CAR-T cells may be administered after completion of 6 months of pirtobrutinib maintenance therapy in selected patients who do not achieve complete response, or who achieve complete response but remain ctDNA-positive, based on investigator assessment and protocol-defined criteria.
Первичные конечные точки
- Complete response rate (CRR) [Срок оценки: At 6 months after initiation of pirtobrutinib maintenance therapy]
Вторичные конечные точки (8)
- Best complete response rate (bCRR) [Срок оценки: Up to 24 months]
- Best objective response rate (bORR) [Срок оценки: Up to 24 months]
- Objective response rate (ORR) [Срок оценки: At 6 months after initiation of pirtobrutinib maintenance therapy]
- Duration of complete response (DoCR) [Срок оценки: Up to 24 months]
- Duration of response (DOR) [Срок оценки: Up to 24 months]
- Progression-free survival (PFS) [Срок оценки: Up to 24 months]
- Overall survival (OS) [Срок оценки: Up to 24 months]
- Incidence of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: Up to 30 days after the last dose of pirtobrutinib]
Критерии участия
Критерии включения
- Able to understand and voluntarily sign the informed consent form.
- Age 18 years or older, male or female.
- Histologically confirmed large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, or transformed follicular lymphoma (tFL).
- Eastern Cooperative Oncology Group performance status of 0 to 2.
- Has received commercial anti-CD19 CAR-T cell therapy, with informed consent obtained before Day 28 after CAR-T cell infusion.
- Prior anti-lymphoma therapy-related adverse events, especially CAR-T-related adverse events, have stabilized and recovered to Grade 1 or lower, except for clinically insignificant toxicities.
Критерии исключения
- History of other malignancies, except non-melanoma skin cancer without recurrence for more than 3 years, carcinoma in situ, such as cervical, bladder, or breast carcinoma, or follicular lymphoma.
- Prior autologous or allogeneic hematopoietic stem cell transplantation.
- Active or suspected uncontrolled fungal, bacterial, viral, or other infection requiring intravenous treatment. Patients with uncomplicated urinary tract infection or uncomplicated bacterial pharyngitis may be enrolled if responding to active treatment.
- History of immunodeficiency, including human immunodeficiency virus infection; positive treponema pallidum antibody; active hepatitis B virus infection; or active hepatitis C virus infection.
- Current or prior history of benign central nervous system disease, such as seizure, cerebrovascular ischemia or hemorrhage, dementia, cerebellar disease, or any central nervous system-related autoimmune disease.
- Lymphoma involvement of the atrium or ventricle.
- Autoimmune disease requiring systemic immunosuppressive or immunomodulatory therapy within 2 years.
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months before enrollment.
- Any comorbidity that may affect or interfere with safety or efficacy assessment.
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
- Sun yat-sen university cancer center — Гуанчжоу
Идентификаторы
NCT: NCT07622784 · T2026-006