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Comparing high and low intensity therapies for relapsed or refractory acute myeloid leukemia

IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT

Phase 3 Interventional Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · NCT06713837

This study is testing whether high-intensity chemotherapy works better than low-intensity treatments for people with relapsed or refractory acute myeloid leukemia.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment339 (estimated)
Ages18 Years and up
SexAll
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Academic / other
Drugs / interventionschemotherapy
Locations47 sites (Brno and 46 other locations)
Trial IDNCT06713837 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, open-label clinical trial evaluates the effectiveness of high intensity reinduction chemotherapy versus low intensity therapies in patients with relapsed or refractory acute myeloid leukemia (AML). The study aims to provide a pragmatic comparison of these treatment approaches, leveraging recent findings that suggest low-intensity therapies may be comparable to traditional chemotherapy. It is designed to accommodate the variability in patient responses and treatment availability across different regions. The trial is funded by the European Commission and involves multiple participating hospitals.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with non-acute promyelocytic leukemia AML who are experiencing their first or second relapse and are eligible for both low intensity and high dose chemotherapy.

Not a fit: Patients who have specific contraindications to either treatment option or those for whom a superior treatment is already available may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less intensive treatment option for patients with relapsed or refractory AML, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promise in comparing low-intensity therapies with standard chemotherapy, but this specific approach is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria
* 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022
* Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician
* Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice
* No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to:

  i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization
* Male or Female, aged\>18 years
* Eastern Cooperative Oncology Group (ECOG) performance status \<4
* A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials". Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials". Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of Summary of Product Characteristics (SmPC) (e.g. hypersensitivity, allergy, organ failure precluding treatment)
* Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization
* Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.

Where this trial is running

Brno and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaRelapse/RecurrenceRelapsed/RefractoryLow Intensity therapyPragmaticLow intervention Clinical trialRandomized controlled trialHorizon Europe
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.