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Идёт набор NCT06339775

Blinatumomab for Relapsed Acute B Lymphoblastic Leukemia After Transplantation

Фаза IV С лечением Acute B-cell Lymphoblastic Leukemia

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: Blinatumomab.
Кому может быть актуально
Состояния в реестре: Acute B-cell Lymphoblastic Leukemia. Базовые параметры: до 65 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
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Официальное название

Blinatumomab Sequential Donor Lymphocyte Infusion in Acute B Lymphocytic Leukemia Observation of Therapeutic Effect in Patients With Recurrence After Allogeneic Hematopoietic Stem Cell Transplantation

Обзор

B-ALL patients received regular follow-up after allogeneic hematopoietic stem cell transplantation, and in case of recurrence, they were given Blinatumomab. Anti-treatment was followed by DLI, and the second course was performed 1-2 months after DLI. Patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment. (MNC infusion is about 5×10\^7/kg\~1×10\^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10\^7/kg\~1×10\^8/kg). Objective To observe and analyze the efficacy and side effects of Blinatumomab followed by donor lymphocyte infusion in patients with relapsed acute B lymphoblastic leukemia after allogeneic hematopoietic stem cell transplantation in our hospital.

Подробное описание

Patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital and received sequential donor lymphocyte infusion （DLI） treatment after relapse. The patients with acute B-cell lymphoblastic leukemia who relapsed after receiving allogeneic hematopoietic stem cell transplantation in our hospital from September 2023 to December 2026 and received sequential donor lymphocyte infusion （DLI） treatment after relapse were enrolled.

1. Age ≤65 years old 2. Stable vital signs 3. No severe infection 4. No grade II-IV graft-versus-host disease 5. No organ failure

Exclusion criteria

1. Age \>65 years old 2. Unstable vital signs 3. Complicated with severe infection 4. Complicated with grade II-IV graft-versus-host disease 5. Organ failure such as heart, liver, kidney, etc. 6. Complicated with central nervous system leukemia 7. Drug allergy to the treatment regimen Treatment regimen B-ALL patients were regularly followed up after allogeneic hematopoietic stem cell transplantation. When relapse occurred, Blinatumomab was given sequentially after DLI, and the second course of treatment was conducted 1-2 months after DLI.

MRD-positive patients were given Blinatumomab 28μg×5-15 days, followed by DLI treatment （infusion of MNC is about 5×10\^7/kg\~1×10\^8/kg）.

Hematologic relapse patients were given Blinatumomab 9μg d1-4,11.66μg d5-7,28μg d8 （a total of 8 to 21 days）, followed by DLI treatment （infusion of MNC is about 5×10\^7/kg\~1×10\^8/kg）. The duration of using Blinatumomab was determined according to the patient's tolerance, economic situation and other comprehensive factors.

Main observation and statistical indicators Overall survival after relapse, disease-free survival, incidence of cytokine release syndrome （CRS）, incidence of acute/chronic graft-versus-host disease （GVHD） after treatment, incidence of infection, incidence of hematological adverse reactions, etc.Compared with patients receiving usual care.

Вмешательства

  • Препарат Blinatumomab
    patients with positive MRD were treated with Blinatumomab 28μg×5-15 days, followed by DLI treatment. (MNC infusion is about 5×10\^7/kg\~1×10\^8/kg). Patients with hematologic recurrence were given Blinatumomab 9μg D1-4,11.66μg d5-7,28μg Starting from d8 （8 to 21 days in total）, followed by DLI treatment (infusion of MNC approximately 5×10\^7/kg\~1×10\^8/kg).

Первичные конечные точки

  • Overall survival [Срок оценки: three years]
  • Disease-free survival [Срок оценки: three years]
Вторичные конечные точки (3)
  • incidence of cytokine release syndrome （CRS） [Срок оценки: 2 weeks later]
  • Incidence of acute/chronic graft-versus-host disease （GVHD） [Срок оценки: 2 weeks later]
  • hematological adverse reactions Incidence rate [Срок оценки: 2 weeks later]

Критерии участия

Критерии включения

  • Age ≤65 years old
  • Stable vital signs
  • No severe infection
  • There was no grade II-IV graft-versus-host disease
  • No organ failure

Критерии исключения

  • Age > 65 years old
  • Unstable vital signs
  • Complicated with severe infection
  • Combined with grade Ⅱ-Ⅳ graft-versus-host disease
  • Heart, liver, kidney and other organ failure
  • Complicated with central nervous system leukemia
  • Allergies to medications in the treatment regimen

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
  • The First Affiliated Hospital of Zhengzhou University — Zhenzhou

Публикации

  • Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067. PMID 41671463

Идентификаторы

NCT: NCT06339775 · 2024318

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗