RecruitingPhase 3NCT06418776

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

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


Sponsor

National Research Center for Hematology, Russia

Enrollment

198 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing different treatments for relapsed or refractory acute myeloid leukemia (AML) — a type of blood cancer that has either stopped responding to treatment or come back after treatment. It is a randomized trial, meaning participants are assigned to different treatment groups to compare results. **You may be eligible if...** - You are 18 or older - You have been diagnosed with AML that is either not responding to initial treatment (primary refractory) or has come back early after treatment (early relapse) - You have signed informed consent **You may NOT be eligible if...** - Your AML relapsed late (long after treatment ended) - Your AML has spread only outside the bone marrow - Your cancer has only relapsed based on lab markers without full bone marrow relapse - You have acute promyelocytic leukemia (a specific AML subtype treated differently) - You have previously failed or stopped responding to venetoclax therapy - You have had a bone marrow or stem cell transplant in the past - You are pregnant or breastfeeding - Your general health is severely limited (ECOG score 3 or above) - You have uncontrolled infection, serious heart problems, or severe kidney disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERIntensive therapy

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

OTHERLow intensity therapy

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


Locations(1)

National Research Center for Hematology

Moscow, Russia

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NCT06418776


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