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Идёт набор NCT07187193

Efficacy and Safety of Low-Dose Cytarabine Combined With Thalidomide in Adult Patients With Untreated LCH

Фаза II С лечением Langerhans Cell Histiocytosis

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: Cytarabine (Ara-C), Thalidomide (100mg).
Кому может быть актуально
Состояния в реестре: Langerhans Cell Histiocytosis. Базовые параметры: 18 лет — 70 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 Low-Dose Cytarabine Combined With Thalidomide in the Treatment of Adult Patients With Untreated Langerhans Cell Histiocytosis: A Prospective, Multicenter, Single-Arm Study.

Обзор

Treatment of Adult Patients with Newly Diagnosed Langerhans Cell Histiocytosis (LCH) Using a Low-Dose Cytarabine Combined with Thalidomide Regimen.

Подробное описание

AraC 100 mg/m² d1-5+ thalidomide 100mg d1-35, q35 days ,for a total of 12 cycles;followed by thalidomide 100mg, qd1-28 q28d,for a total of 12 cycles of monotherapy maintenance reatment;

Вмешательства

  • Препарат Cytarabine (Ara-C)
    The treatment regimen consists of Ara-C administered at a dose of 100 mg/m² from days 1 to 5, combined with thalidomide at a dose of 100 mg from days 1 to 35, repeated every 35 days for a total of 12 cycles. Following this, thalidomide will be given as monotherapy at a dose of 100 mg from days 1 to 28, administered every 28 days for an additional 12 cycles of maintenance treatment. In total, participants will undergo 24 cycles of treatment.
  • Препарат Thalidomide (100mg)
    The treatment regimen consists of AraC administered at a dose of 100 mg/m² from days 1 to 5, combined with thalidomide at a dose of 100 mg from days 1 to 35, repeated every 35 days for a total of 12 cycles. Following this, thalidomide will be given as monotherapy at a dose of 100 mg from days 1 to 28, administered every 28 days for an additional 12 cycles of maintenance treatment. In total, participants will undergo 24 cycles of treatment.

Первичные конечные точки

  • Event-Free Survival (EFS) [Срок оценки: From enrollment to the end of treatment until 3 years]
Вторичные конечные точки (3)
  • Overall survival (OS) [Срок оценки: From enrollment to the end of treatment until 3 years]
  • Overall response rate (ORR) [Срок оценки: From enrollment to the end of treatment until 3 years]
  • Adverse events [Срок оценки: From enrollment to the end of treatment until 3 year]

Критерии участия

Критерии включения

  • Clearly diagnose and treat adult patients with multisystem or single-system multifocal LCH;
  • Aged between 18 and 70 years;
  • Multisystem involvement or single-system multifocal disease;
  • No prior systemic treatment (patients who have only received local radiotherapy or surgery may be enrolled);
  • ECOG performance status score ≤ 2;
  • Judged by clinicians as suitable for treatment with this protocol;
  • Patients or their families able to understand the study protocol and willing to participate in the study, providing written informed consent.

Критерии исключения

  • Patients with LCH involving the central nervous system;
  • Single-system single-lesion LCH;
  • Subjects who have undergone major surgery within 4 weeks prior to the first dose in the study;
  • Subjects who have received radiotherapy within 4 weeks prior to the first dose in the study; subjects with a history of myocardial infarction within the past year;
  • Patients with New York Heart Association (NYHA) class 3 or 4 congestive heart failure, or a history of NYHA class 3 or 4 congestive heart failure;
  • Pregnant or lactating women;
  • Abnormal liver and kidney function: creatinine level ≥176.8μmol/l (2mg/dl), transaminase and bilirubin levels more than 2 times the upper limit of normal (for LCH patients with liver involvement, bilirubin levels more than 10 times the upper limit of normal);
  • Abnormal blood counts: absolute neutrophil count less than 1×10\^9/L, platelet count less than 50×10\^9/L;
  • Patients or their families unable to understand the conditions and objectives of this study;
  • Any other circumstances in which the investigator deems the patient unsuitable to participate in this trial.

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
  • Department of Medical Oncology, National Cancer Center/National Clinical Research Center f — Пекин

Идентификаторы

NCT: NCT07187193 · NCCH006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗