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Recruiting NCT06418776

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

Phase III Interventional Refractory Acute Myeloid Leukemia Early Relapses of Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intensive therapy, Low intensity therapy.
Who it may be relevant to
Registry conditions: Refractory Acute Myeloid Leukemia, Early Relapses of Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Event-free survival of patients with R/R AML depending on the use of high or low intensity therapy exposure before alloHSCT [Time frame: 2 years]
Secondary outcome measures (9)
  • Probability of achieving CR in patients with R/R AML, depending on the use of high or low intensity treatment regimens [Time frame: 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 [Time frame: 3 months]
  • Cumulative incidence of alloHSCT in patients with R/R AML, depending on the use of high or low intensity treatment regimens [Time frame: 2 years]
  • Toxicity of high versus low intensity regimens [Time frame: 3 months]
  • OS over the entire duration of the study, including follow-up after alloHSCT [Time frame: 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 [Time frame: 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 [Time frame: 2 years]
  • EFS of patients with R/R AML depending on the use of high or low intensity regimens, regardless of alloHSCT [Time frame: 2 years]
  • Statistics on discontinued participation in the protocol and premature withdrawal from the study [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • National Research Center for Hematology — Moscow

Identifiers

NCT: NCT06418776 · IMPACT-AML

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗