IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML

Официальное название

A Prospective Multicenter Randomized Clinical Trial on the Treatment of Patients With Refractory or Early Relapses of Acute Myeloid Leukemia

Обзор

The primary objective is to evaluate the efficacy and toxicity of high versus low intensity therapy options in patients with refractory forms and early relapses of acute myeloid leukemia (R/R AML) who are scheduled for allogeneic hematopoietic stem cell transplantation (alloHSCT).

Вмешательства

• Другое Intensive therapy
  Intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito)
• Другое Low intensity therapy
  Low intensity therapy (Aza+Ven, Dac+Ven, LDARA-C+Ven)

Первичные конечные точки

• Event-free survival of patients with R/R AML depending on the use of high or low intensity therapy exposure before alloHSCT [Срок оценки: 2 years]

Вторичные конечные точки (9)

• Probability of achieving CR in patients with R/R AML, depending on the use of high or low intensity treatment regimens [Срок оценки: 3 months]
• Probability of achieving a response (CR, CR with incomplete hematological recovery, morphologic leukemia- free state, partial remission) in patients with R/R AML, depending on the use of high or low intensity treatment regimens [Срок оценки: 3 months]
• Cumulative incidence of alloHSCT in patients with R/R AML, depending on the use of high or low intensity treatment regimens [Срок оценки: 2 years]
• Toxicity of high versus low intensity regimens [Срок оценки: 3 months]
• OS over the entire duration of the study, including follow-up after alloHSCT [Срок оценки: 2 years]
• RFS in patients with R/R AML when achieving remission before alloHSCT, depending on the use of high or low intensity treatment regimens [Срок оценки: 2 years]
• Relapse incidence in patients with R/R AML when achieving remission before performing alloHSCT, depending on the use of high or low intensity treatment regimens [Срок оценки: 2 years]
• EFS of patients with R/R AML depending on the use of high or low intensity regimens, regardless of alloHSCT [Срок оценки: 2 years]
• Statistics on discontinued participation in the protocol and premature withdrawal from the study [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Age ≥ 18 years;
• Primary refractory AML;
• Early relapsed AML;
• A signed informed consent to participate in the study.

Критерии исключения

• Late relapsed AML;
• Isolated extramedullary relapse;
• MRD relapse without development of bone marrow relapse of AML;
• Acute promyelocytic leukemia;
• Previous refractoriness or loss of response during ongoing venetoclax therapy;
• Previous alloHSCT;
• Pregnancy and/or lactation period;
• Refusal of patients with preserved reproductive potential to use highly effective methods of contraception during the period of participation in the study;
• Lack of signed informed consent to participate in the study;
• Failure of the subject to follow the study protocol;
• Participation in any other clinical trial;
• Uncontrolled infectious complications;
• ECOG ≥ 3;
• History of other malignancies within the past 3 years, excluding squamous cell and basal cell skin cancers, carcinoma in situ of the cervix, breast, or other non-invasive malignancies, which, in the opinion of the investigator, are considered adequately treated and have a minimal risk of recurrence within 3 years;
• Chronic kidney disease with GFR ≤ 30 ml/min/1.73 m2 (according to the CKD-EPI Creatinine Equation);
• Severe cardiac pathology:

• uncontrolled arterial hypertension;
• stable angina III-IV functional classes;
• unstable angina and/or myocardial infarction less than 6 months before inclusion in the study;
• heart failure stages IIb-III, NYHA functional classes III-IV
• uncontrolled cardiac rhythm disturbances (≥ 2 grade CTCAE 5.0) or clinically significant ECG abnormalities.
• Cirrhosis classes B-C according to the Child-Pugh classification
• Increased liver function tests above the following values:

• Total bilirubin > 1,5 above the normal range;
• AST, ALT > 10 above the normal range.
• Major surgical interventions underwent less than 14 days before inclusion in the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Россия · 1 центр

• National Research Center for Hematology — Moscow

Идентификаторы

NCT: NCT06418776 · IMPACT-AML

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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