MRD-positive AML Clinical Study

Официальное название

MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study

Обзор

This clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs, liposome drugs and the combination of these drugs to form a combination of treatment regimen, the specific treatment regimen will be updated according to the results of this trial and the latest research progress at home and abroad.

Подробное описание

Patients aged 14 years or older with diagnosed AML (non-M3) who have achieved complete remission in bone marrow morphology but are positive for minimal residual disease by flow cytometry or have the following genetic mutations that can be detected by PCR: NPM1 mutation, IDH1/2 mutation, DEK-NUP214 (DEK-CAN), RUNX1-RUNX1T1(AML 1-ETO), or CBFβ-MYH 11\[4\]. NGS can detect mutations such as FLT3.

For eligible patients, the treatment plan is selected by the doctor in charge according to the specific conditions of the patient. During the treatment, patients can have hematopoietic stem cell transplantation at any time.

This study compared relapse-free survival and overall survival of MRD-positive patients after effective and persistent MRD treatment, and based on the results, observed the efficacy and safety of different treatment regiments for MRD-positive AML patients.

Вмешательства

• Препарат Ivosidenib
  500mg d1-28
• Препарат Gilteritinib
  120mg d1-28
• Препарат Venetoclax
  400mg d1-21 ; 400mg d1-7;400mg d1-28; 600mg d1-21
• Препарат Avapritinib
  200mg d1-28.
• Препарат Daunorubicin
  45mg/m2/d d1-2;
• Препарат Cytarabine
  100mg/m2/d d1-5
• Препарат Idarubicin
  10mg/m2/d d1-2
• Препарат MTZ
  8mg/m2/d d1-2
• Препарат HHT
  2mg/m2/d d1-5
• Препарат Azacitidine
  75mgd/m2 d1-7.

Первичные конечные точки

• relapse-free survival rate [Срок оценки: up to 6 months]

Вторичные конечные точки (6)

• Measurable Residual Disease [Срок оценки: up to 6 months]
• Proportion of MRD turning negative [Срок оценки: up to 6 months]
• Overall survival(OS ) rate [Срок оценки: From the time the patients participated in the clinical trial until the patient died]
• Cumulative relapse rate [Срок оценки: From the time the patients participated in the clinical trial until the patient relapsed]
• Adverse Events (AEs) [Срок оценки: up to 2 years]
• The incidence of adverse events such as serious infections during treatment [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

• AML (non-M3) compliant with WHO (2016) standards;
• In morphological complete remission.
• Mrd-positive patients: including bone marrow flow cytometry, PCR quantification of NPM1 mutations, PCR quantification of fusion genes (RUNX 1-RUNX1T1, CBFB-MYH11 and DEK-NUP214), or NGS detection of FLT3 mutation positive.
• Age over 14 years old, male or female. Informed consent must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, informed consent must be signed by the patient or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.

Критерии исключения

• Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks
• The diagnosis is APL
• Those who were not considered suitable for inclusion by the researchers.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Blood Diseases Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07131059 · IIT2024032

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗