Меню
Идёт набор NCT07564453

Full-course Immunotherapy Combined With Chemotherapy in Newly Diagnosed B-cell Acute Lymphoblastic Leukemia

Фаза II С лечением B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative

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, Induction Chemotherapy, Hyper-CVAD, Allogeneic hematopoietic stem cell transplantation.
Кому может быть актуально
Состояния в реестре: B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative. Базовые параметры: 15 лет — 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This is a single-arm, prospective, phase 2 clinical trial evaluating the improvement of survival outcomes of blinatumomab combined with chemotherapy as a full-course treatment regimen in patients with newly diagnosed Philadelphia chromosome-negative (Ph-negative) B-cell precursor acute lymphoblastic leukemia (B-ALL). The study adopts a "reduced-dose chemotherapy + full-course immunotherapy" strategy: induction therapy with reduced-dose chemotherapy combined with blinatumomab to improve remission rate and tolerability; consolidation therapy with alternating Hyper-CVAD (A/B) regimen，blinatumomab and sequential CD19-directed CAR-T therapy to deepen minimal residual disease (MRD) clearance; allogeneic hematopoietic stem cell transplantation (allo-HSCT) for some patients (e.g., KMT2A rearrangement, TP53 mutation, persistent MRD positivity, MRD recurrence); and no maintenance therapy. The primary endpoint is 2-year relapse-free survival (RFS). Secondary endpoints include 2-year overall survival (OS), the proportion and time to achieve complete response (CRc), and the proportion and time to achieve minimal residual disease (MRD) negativity. The trial plans to enroll 101 patients aged 15-65 years to demonstrate improved survival outcomes compared with historical controls .

Вмешательства

  • Биопрепарат Blinatumomab
    Induction phase: 9 µg/day on days 8-14, 28 µg/day on days 15-21; If D22 BM not CR/CRi, continue Blinatumomab for next 2 weeks of 28 µg/day; Consolidation phase: 28 µg/day for 28 days.
  • Препарат Induction Chemotherapy
    Reduced-dose induction regimen: Idarubicin 8 mg/m², intravenous, day 1; Vindesine 3 mg/m² (max 4 mg), intravenous, day 1; Dexamethasone 9 mg/m²/day, intravenous, days 1-7. Combined with blinatumomab
  • Препарат Hyper-CVAD
    Alternating intensive consolidation chemotherapy: Hyper-CVAD-A: Cyclophosphamide ,Vincristine , Doxorubicin , Dexamethasone ; Hyper-CVAD-B: Methotrexate , Cytarabine . Alternated with CD19-CART and blinatumomab
  • Процедура Allogeneic hematopoietic stem cell transplantation
    Allogeneic hematopoietic stem cell transplantation, performed after consolidation therapy in patients with KMT2A rearrangement, TP53 mutation, persistent MRD positivity or MRD recurrence
  • Биопрепарат CAR-T cell therapy
    CD19-CART is administered sequentially in the consolidation phase: First infusion : Following the first course of blinatumomab (28 µg/day, IV, days 1-28) before subsequent Hyper-CVAD chemotherapy. Second infusion : After completion of alternating Hyper-CVAD and blinatumomab consolidation cycles.

Первичные конечные точки

  • 2-year relapse-free survival (RFS) [Срок оценки: From enrollment through 2 years post-last patient enrolled]
Вторичные конечные точки (3)
  • 2-year overall survival (OS) [Срок оценки: From enrollment through 2 years post-last patient enrolled]
  • Composite Complete Remission (CR/CRi) Rate after Induction Therapy [Срок оценки: From randomization to 2 cycles of induction before consolidation therapy(100 days)]
  • Minimal Residual Disease (MRD) Negativity Rate [Срок оценки: From randomization to 2 cycles of induction before consolidation therapy(100 days)]

Критерии участия

Критерии включения

  • Age ≥15 years and ≤65 years.
  • Newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) according to WHO diagnostic criteria, with CD19 expression ≥ 20%
  • De novo patients with no prior induction therapy (excluding hydroxyurea and corticosteroid use for ≤ 5 days)
  • ECOG performance status score 0-3.
  • Liver function: Total bilirubin ≤ 3 times the upper limit of normal (ULN); alanine transaminase (ALT) ≤ 3×ULN; aspartate transaminase (AST) ≤ 3×ULN; (leukemic infiltration is excluded).
  • Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL/min
  • Able to understand and voluntarily participate in the study, and provide written informed consent

Критерии исключения

  • Philadelphia chromosome-positive (Ph+, BCR-ABL1+) ALL
  • T-cell acute lymphoblastic leukemia
  • Mature B-cell leukemia/lymphoma, B-cell lymphoblastic lymphoma, extramedullary invasion
  • Acute mixed phenotype acute leukemia (MPAL)
  • Central nervous system (CNS) leukemia
  • HIV infection
  • Positive HBV-DNA or HCV-RNA
  • New York Heart Association (NYHA) functional class ≥ II, or other conditions deemed unsuitable for enrollment by the investigator
  • Pregnant or lactating patients
  • Patients who refuse to enroll in the 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
  • The First Affiliated Hospital of Soochow University — Сучжоу

Идентификаторы

NCT: NCT07564453 · ALL-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗