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Идёт набор NCT07663864

Luspatercept for CIA in AML

Фаза I / Фаза II С лечением Chemotherapy-inducing Anemia

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: Luspatercept Injectable Product.
Кому может быть актуально
Состояния в реестре: Chemotherapy-inducing Anemia. Базовые параметры: 18 лет — 60 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 Luspatercept in Treating Chemotherapy-inducing Anemia in Acute Myeloid Leukemia: a Multicenter, Prospective, Single-arm Study

Обзор

This study aims to explore the feasibility, safety, and preliminary efficacy of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML with a multicenter, prospective, single-arm trial, providing clinical evidence for subsequent clinical development.

Подробное описание

The application of rotegcipipone in the treatment of chemotherapy-inducing anemia in AML has not yet been systematically studied. Animal studies have shown that rotegcipipone can improve the recovery of anemia after chemotherapy. The bone marrow microenvironment after chemotherapy is often deteriorated due to cytokine storms and hematopoietic stem cell damage, which may further exacerbate erythroid regeneration disorders. Based on rotegcipipone's dual mechanism of improving the hematopoietic microenvironment and promoting erythrocyte maturation, it may overcome the limitations of existing therapies after chemotherapy. Furthermore, its safety profile (primarily grade 1-2 adverse reactions in MDS and β-thalassemia) provides a potential advantage for its application in vulnerable patients after chemotherapy.

Вмешательства

  • Препарат Luspatercept Injectable Product
    First, enrolled patients were randomized to received rotezipeptide with a dosage of 1mg/kg at the day 1 versus day 10 post chemotherapy. Each groups were analyzed to enroll et least 10 patients. Second, after working out which day should be the better one for the treatment of rotezipeptide in phase 1 study, at least 20 patients were enrolled to received rotezipeptide with the same dose at the above day to further work out the efficacy and safety of rotezipeptide in the treatment of CIA in AML.

Первичные конечные точки

  • Time of 50% increase in hemoglobin levels from baseline [Срок оценки: Days 1-28 post chemotherapy]
Вторичные конечные точки (5)
  • Duration of HGB < 60 G/L during the treatment course (1-28 days) [Срок оценки: Days 1-28 after AML chemistry treatment]
  • Incidence of HGB < 60 G/L during the treatment course (days 1-28) [Срок оценки: Days 1-28 after chemotherapy]
  • Red blood cell transfusion volume [Срок оценки: Days 1-28 after AML chemistry treamtment]
  • MRD negative rate [Срок оценки: 6 months after AML chemistry treamtment]
  • Anemia recurrence rate [Срок оценки: 12 months after AML chemistry treamtment]

Критерии участия

Критерии включения

  • De novo AML patients;
  • Age ≥ 18 years and ≤ 60 years;
  • AML with ELN2022-low risk
  • Received 1-3 cycles of HDAC consolidation therapy
  • HGB 60-90 G/L
  • Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points;
  • Life expectancy ≥ 3 months;
  • Signed informed consent and able to understand and comply with the procedures required by this protocol.

Критерии исключения

  • t-AML/sAML
  • Concurrent myelofibrosis
  • Patients unresponsive to red blood cell transfusions
  • Heart function < grade 2
  • Renal function: creatinine clearance < 30 ml/min
  • Liver function: ALTd > 5 times normal, bilirubin > 3 times normal
  • Uncontrolled hypertension, defined as recurrent elevations in diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
  • History of stroke, deep vein thrombosis (DVT), pulmonary or arterial embolism within 6 months prior to randomization
  • Uncontrolled systemic fungal, bacterial, or viral infection (defined as persistent infection-related signs/symptoms that do not improve despite appropriate antibiotic, antiviral, and/or other treatments), known human immunodeficiency virus (HIV), active hepatitis B virus (HBV) infection, and/or hepatitis C. (HCV) infection
  • History of severe allergy or allergic reaction to recombinant proteins, or allergy to rotezip or excipients
  • Pregnant or breastfeeding women
  • Patients deemed unsuitable for enrollment by the investigators

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 Hematology, Guangdong Second Provincial General Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07663864 · GD2H-2026-483

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗