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Идёт набор NCT06481241

Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Ph- B-ALL

Без фазы С лечением Philadelphia Chromosome Negative ALL Acute Lymphoblastic Leukemia, Adult

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: CAR-T cells, Venetoclax.
Кому может быть актуально
Состояния в реестре: Philadelphia Chromosome Negative ALL, Acute Lymphoblastic Leukemia, Adult. 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

Efficacy and Safety of Chemotherapy Combined With CAR-T Cells in Newly Diagnosed Adult Patients With Philadelphia Chromosome-Negative B-cell Acute Lymphoblastic Leukemia

Обзор

In recent years, immunotherapy (eg. blinatumomab, inotuzumab ozogamicin, CAR-T cells) has demonstrated a high safety and efficacy profile in relapsed/refractory (R/R）B-ALL. The available data suggest that the advancement of immunotherapy from relapsed/refractory (R/R) field to the frontline setting may be an important approach to increase the depth of remission, which ultimately translates into a survival benefit. In this study, the investigators propose a treatment regimen using CAR-T cell therapy as a consolidation method for Ph- B-ALL patients achieving complete remission (CR) with chemotherapy, aiming to reduce the total cycles of chemotherapy and related toxicities, shorten length of hospitalization, and ultimately improve patients' survival and quality of life.The study endpoints include 2-year disease-free survival (DFS) rate, overall survival (OS) rate, event-free survival (EFS) rate, cumulative molecular remission rate, immune repertoire-minimal residual disease (MRD) remission rate, cumulative relapse rate, treatment-related toxicities, and quality of life. Additionally, an interim analysis will be conducted, with the 1-year DFS rate as the key index for this analysis.

Подробное описание

The CAR-T cells were murine-derived second-generation CD19 CAR-T with a co-stimulation domain of 4-1BB, and the infusion dose was 1×10\^6/kg CAR+ cells in a single infusion.

Вмешательства

  • Комбинированный продукт CAR-T cells
    CAR-T cells as consolidation therapy
  • Препарат Venetoclax
    VEN

Первичные конечные точки

  • Disease-free Survival (DFS) [Срок оценки: Up to 2 years post-registration]
Вторичные конечные точки (6)
  • MRD-negative complete remission rate measured by flow cytometry. [Срок оценки: After induction (4 week)]]
  • Overall survival (OS) [Срок оценки: Up to 5 years post-registration]
  • Event-free survival (EFS) [Срок оценки: Up to 5 years post-registration]
  • MRD-negative complete remission rate measured by NGS tracking clonal IG/TR rearrangements [Срок оценки: Up to 1 year post-registration]
  • Cumulative incidence of relapse (CIR) [Срок оценки: Up to 2 years post-registration]]
  • The rate of adverse events [Срок оценки: Up to 5 years post-registration]

Критерии участия

Критерии включения

  • De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification
  • Male or female patients aged 18 years or older
  • CD19 expression on blasts
  • Expected survival time greater than 3 months
  • Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%
  • Subject has provided written informed consent prior to any screening procedure

Критерии исключения

  • Burkitt lymphoma/leukemia
  • Acute Leukemia of Ambiguous Lineage
  • Clinical manifestations of active CNS or extramedullary involvement with ALL
  • Female patients who are pregnant or breast feeding
  • Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment
  • Known HIV seropositivity
  • Clinically significant ventricular arrhythmias, unexplained syncope (not vasovagal) or sinus block, history of chronic bradycardia with a high degree of atrioventricular (AV) conduction block (unless a permanent pacemaker is implanted)
  • Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
  • Other conditions assessed by the investigators to be inappropriate for this 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
  • Institute of Hematology & Blood Diseases Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06481241 · IIT2024020

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗