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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2029-05-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Refractory Acute Myeloid Leukemia Early Relapses of Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients who could potentially undergo courses of intensive chemotherapy ("fit") are randomisedrandomized into two arms:

* Arm 1 - intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito)
* Arm 2 - low intensity therapy (Aza/Dac/LDARA-C + Ven) Randomization determines the intensity of the program, but not the specific therapeutic regimen. The treatment regimen is selected by the investigators based on accepted clinical practice, the availability of appropriate drugs at the participating centers, etc., after randomization. If a patient has FLT3 gene mutations, one of the available kinase inhibitors must be added to therapy: midostaurin, gilteritinib, sorafenib.

If remission of the AML has been achieved, patients in both groups undergo alloHSCT as soon as possible.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive arm

Fit patients who could potentially undergo courses of intensive chemotherapy and are randomized to intensive chemotherapy courses

Group Type ACTIVE_COMPARATOR

Intensive therapy

Intervention Type OTHER

Intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito)

Low-intensive arm

Fit patients who could potentially undergo courses of intensive chemotherapy and are randomized to low intensity courses

Group Type ACTIVE_COMPARATOR

Low intensity therapy

Intervention Type OTHER

Low intensity therapy (Aza+Ven, Dac+Ven, LDARA-C+Ven)

Interventions

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Intensive therapy

Intensive chemotherapy courses (MEC, FLAG, FLAG-Ida, FLAG-Mito)

Intervention Type OTHER

Low intensity therapy

Low intensity therapy (Aza+Ven, Dac+Ven, LDARA-C+Ven)

Intervention Type OTHER

Eligibility Criteria

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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:

1. uncontrolled arterial hypertension;
2. stable angina III-IV functional classes;
3. unstable angina and/or myocardial infarction less than 6 months before inclusion in the study;
4. heart failure stages IIb-III, NYHA functional classes III-IV
5. 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:

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No