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Идёт набор NCT07586735

A Novel Conditioning Regimen for Haplo-HSCT in Older Patients With SAA

— Наблюдательное Severe Aplastic Anemia Aplastic Anaemia Hematopoietic Cell Transplant

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: BFCA conditiong regimen.
Кому может быть актуально
Состояния в реестре: Severe Aplastic Anemia, Aplastic Anaemia, Hematopoietic Cell Transplant. Базовые параметры: 40 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
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Официальное название

A Novel Conditioning Regimen for Haploidentical Hematopoietic Stem Cell Transplant in Patients Aged ≥ 40 Years Old With Severe Aplastic Anemia: a Multicenter, Single-arm, Observational Clinical Trial

Обзор

The goal of this prospective, multicenter, single arm observational study is to evaluate the efficacy and safety of the BFCA regimen in ≥ 40 years old SAA patients undergoing haplo-HSCT.

Вмешательства

  • Препарат BFCA conditiong regimen
    busulfan 0.8 mg/kg/6h (days -8 to -7), fludarabine 30mg/m2/day (days -6 to -2), cyclophosphamide 25 mg/kg/day (days -5 to -2) and antithymocyte globulin(ATG) 2.5 mg/kg/day (days -5 to -2).

Первичные конечные точки

  • Faliure free survival (FFS) [Срок оценки: From enrollment to 2 years post-HSCT]
Вторичные конечные точки (7)
  • The probability of Overall survival [Срок оценки: From enrollment to 2 years post-HSCT]
  • Myeloid and platelet engraftment [Срок оценки: 100 days post HSCT]
  • The incidence of mixed chimerism [Срок оценки: 1 year post HSCT]
  • The incidence of graft versus host disease(GVHD) [Срок оценки: 100 days post HSCT for aGvHD and 2 years post HSCT for cGvHD]
  • Regimen related toxicity [Срок оценки: 100 days post HSCT]
  • The incidence of Cytomegalovirus(CMV) and Epstein-Barr virus(EBV) reactivation [Срок оценки: 180 days post HSCT]
  • The incidence of Transplantation related mortality [Срок оценки: 2 years post HSCT]

Критерии участия

Критерии включения

  • Severe aplastic anemia;
  • Aged 40-60 years old;
  • Weight 45Kg-100Kg;
  • Eastern Cooperative Oncology Group (ECOG) score ≤3;
  • No major organ injury (ECG ejection fraction >45%; bilirubin < 2 times the upper limit of normal value; AST and ALT < 3 times the upper limit of normal value; serum creatinine < 2 times the upper limit of normal value);
  • No severe infection;
  • Subjects voluntarily participated in this clinical trial and signed the informed consent.

Критерии исключения

  • With other hematologic diseases;
  • Expected survival of less than 1 month;
  • Previous autologous or allogeneic hematopoietic stem cell transplantation;
  • Pregnant patients;
  • Patients with severe mental or neurological disorders that would affect the ability to provide informed consent and/or to report or observe adverse events;
  • Other conditions that the investigator determines to be inappropriate for enrollment.
  • Current or recent (<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection
  • A history of symptomatic herpes zoster infection within 12 weeks prior to screening
  • Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
  • Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB
  • Exposure to a live vaccine within 12 weeks prior to enrollment or expected to receive a live vaccine during the study
  • Clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled
  • Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure
  • A history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data
  • Any of the following specific abnormalities on screening laboratory tests:
  • ALT or AST >2 x ULN, or total bilirubin ≥1.5 x ULN
  • hemoglobin <9 g/dL, or total white blood cell (WBC) count <2,500/µL, or neutropenia (absolute neutrophil count <1,200/µL), or lymphopenia (lymphocyte count <750/µL)
  • eGFR <50 mL/min/1.73 m2

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Peking Universtiy Peoples' Hospital — Пекин

Идентификаторы

NCT: NCT07586735 · PUPH20260508

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗