Меню
Набор скоро начнётся NCT07573670

A Phase 2 Study of Bcl-2 Inhibitor Combined With Azacitidine for Newly Diagnosed Mixed Phenotype Acute Leukemia

Фаза II С лечением Newly Diagnosed Mixed Phenotype Acute 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: BCL-2 indibitor, Azacitidine (AZA), Blinatumomab.
Кому может быть актуально
Состояния в реестре: Newly Diagnosed Mixed Phenotype Acute Leukemia. Базовые параметры: 16 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 →

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

Официальное название

A Prospective, Open-Label, Single-Arm, Two-Cohort Phase 2 Clinical Study to Evaluate the Efficacy and Safety of Bcl-2 Inhibitor Combined With Azacitidine in the Treatment of Newly Diagnosed Mixed Phenotype Acute Leukemia

Обзор

This is a prospective, open-label, single-arm, two-cohort Phase 2 clinical study designed to evaluate the efficacy and safety of Bcl-2 Inhibitor combined with azacitidine (with blinatumomab added in B/myeloid subtype) in patients with newly diagnosed mixed phenotype acute leukemia (MPAL). Eligible subjects are divided into two cohorts based on immunophenotype: Cohort A (T/Myeloid MPAL) receives Bcl-2 Inhibitor + azacitidine, and Cohort B (B/Myeloid MPAL) receives Bcl-2 Inhibitor + azacitidine + blinatumomab. The treatment cycle is 28 days, with the primary efficacy endpoint assessed after 2 cycles of induction therapy. Patients who achieve CRc will undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) following 2 to 3 cycles of consolidation therapy.The total enrollment period is 24 months, and all subjects will be followed up for at least 24 months from the first day of the first cycle (C1D1). The primary objective is to evaluate the composite complete response (CRc) rate after 2 cycles of induction therapy , and the secondary objectives include evaluating measurable residual disease (MRD) negativity rate, bridge-to-allogeneic hematopoietic stem cell transplantation (allo-HSCT) rate in first complete response (CR1), overall survival(OS),Event-Free Survival(EFS),Relapse-Free Survival(RFS) and Safety.

Вмешательства

  • Препарат BCL-2 indibitor
    Sonrotoclax:40mg qd (D1), 80mg qd (D2), 160mg qd (D3), 320mg qd (D4-D21), oral; * 2 cycles.
  • Препарат Azacitidine (AZA)
    75mg/m² qd (D1-D7), subcutaneous injection; 28-day cycle, ≥2 cycles
  • Препарат Blinatumomab
    9μg/day (D8-D14), 28μg/day (D15-D21), continuous intravenous infusion

Первичные конечные точки

  • Composite Complete Response (CRc) rate after 2 cycles of induction therapy [Срок оценки: From randomization to 2 cycles of induction before consolidation therapy（100 days）]
Вторичные конечные точки (8)
  • MRD negativity rate [Срок оценки: From randomization to 2 cycles of induction before consolidation therapy（100 days）]
  • NGS-MRD negativity rate [Срок оценки: From randomization to 2 cycles of induction before consolidation therapy（100 days）, and test Every 3 months during follow-up]
  • CR1 bridge-to-allo-HSCT rate [Срок оценки: Up to 6 months after enrollment]
  • Overall Survival (OS) [Срок оценки: From the time from randomization to time for up to 2 years]
  • Event-Free Survival (EFS) [Срок оценки: From the time from randomization to time for up to 2 years]
  • Relapse-Free Survival (RFS) [Срок оценки: From the time from randomization to time for up to 2 years]
  • 100-day Non-Relapse Mortality (100-day NRM) [Срок оценки: Up to 100 days after initial MPAL diagnosis]
  • Incidence of grade ≥3 adverse events (AEs) [Срок оценки: From treatment initiation to the end of Induction]

Критерии участия

Критерии включения

  • Aged 16 to 70 years old
  • Newly diagnosed MPAL confirmed by the 2022 WHO/ICC classification criteria for hematopoietic and lymphoid neoplasms
  • Previously untreated; use of glucocorticoids or hydroxyurea for ≤7 days to control tumor burden before enrollment is allowed, no other systemic anti-leukemia therapy
  • ECOG performance status score 0-3
  • No severe combined heart, brain, lung, liver or kidney disease, judged by the investigator to tolerate the study regimen
  • Able to understand and voluntarily sign a written informed consent form

Критерии исключения

  • BCR::ABL-positive MPAL patients
  • Presence of active, uncontrolled infection
  • Known uncontrolled active central nervous system leukemia (CNSL)
  • Life-threatening extramedullary disease requiring urgent radiotherapy or surgical debulking
  • Severe cardiac insufficiency with left ventricular ejection fraction (LVEF) <40%
  • Previous receipt of systemic anti-leukemia therapy
  • Pregnant or lactating female subjects
  • Judged by the investigator to be ineligible for the study for other reasons

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

Китай · 1 центр
  • The First Affiliated Hospital of Soochow University — Сучжоу

Идентификаторы

NCT: NCT07573670 · MPAL-1

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗