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Идёт набор NCT06257394

Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

Фаза II С лечением Acute Lymphoblastic Leukemia, Pediatric

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: Dasatinib(Sprycel) arm, Non-Dasatinib(Sprycel) arm.
Кому может быть актуально
Состояния в реестре: Acute Lymphoblastic Leukemia, Pediatric. Базовые параметры: 1 год — 19 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
South Korea
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

Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

Обзор

Very high-risk acute lymphoblastic leukemia

Подробное описание

* Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.)

* Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3

1. If Minimal Residual Disease \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → DI(Delayed Intensification) #1 → IM(Interim Maintenance) #2 → DI(Delayed Intensification) #2 → Maintenance 2. If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation) * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)

1. If Minimal Residual Disease \& qPCR(Quantitative Polymerase Chain Reaction) not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, HD Cytarabine 2. If Minimal Residual Disease or qPCR(Quantitative Polymerase Chain Reaction) positivie after the post-reinduction : Consolidation #3 using Blinatumomab

* In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib. * Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction

* Morphologic Complete Remission after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3

1. If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation) 2. If Minimal Residual Disease positivie after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT(Hematopoietic Stem Cell Transplantation) * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT(Hematopoietic Stem Cell Transplantation)

1. If Minimal Residual Disease not detected after the post-consolidation #1 : Consolidation #3 using High Dose Methotrexate, High Dose Cytarabine 2. If Minimal Residual Disease positivie after the post-reinduction : Consolidation #3 using Blinatumomab

Вмешательства

  • Препарат Dasatinib(Sprycel) arm
    ▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.) * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance 2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Al
  • Препарат Non-Dasatinib(Sprycel) arm
    ▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT 2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3‡ → Allogeneic

Первичные конечные точки

  • Event free survival [Срок оценки: Up to 5 years]
Вторичные конечные точки (5)
  • Overall survival [Срок оценки: Up to 5 years]
  • Recurred rate [Срок оценки: Up to 5 years]
  • Death rate related to infusion [Срок оценки: Up to 5 years]
  • Adverse Event [Срок оценки: From Day 1 of the clinical trial to 28 days after last drug administration]
  • The rate of Hematopoietic stem cell transplantation [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

  • Pediatric patients diagnosed with ALL between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions:
  • Philadelphia chromosome-positive t(9;22)(q34;q11) or
  • Patients with failed remission who had blast > 5% on bone marrow test after initial remission induction therapy or
  • Hypodiploidy (Number of chromosomes \< 44 (less than 44)) or
  • E2A-HLF(Hepatic Leukemia Factor) translocation-positive or
  • When the prognosis is judged to be poor according to NGS-MRD results among high-risk ALL patients (i) In B-ALL, the NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) after consolidation therapy is 0.01% or more, and the NGS-MRD followed during interim maintenance treatment is also 0.01% or more, (ii) In T-ALL, NGS-MRD(Next Generation Sequencing-Minimal Residual Disease) is more than 0.01% after consolidation therapy

Критерии исключения

  • Participants with contraindications to medications
  • When the study participant or their legal representative withdraws consent
  • Pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period)
  • Participants who are medically unsuitable to participate in this study at the discretion of the investigator Participants participating in other interventional studies other than this protocol

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

South Korea · 10 центров
  • Kyungpook National University Chilgok-Hospital — Daegu
  • Chungnam National University Hospital — Daejeon
  • Chonnam National University Hwasun Hospital — Hwasun
  • Jeju National University Hospital — Jeju City
  • Seoul National University Hospital — Seoul
  • Severance Hospital — Seoul
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul
  • … и ещё 2 центра

Идентификаторы

NCT: NCT06257394 · H-2401-028-1500

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗