Compares intensive and gentler treatments for relapsed acute myeloid leukemia
Compares intensive chemotherapy with gentler treatments in adults with returning acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.
Key facts
- Where
- Amman, JordanSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose acute myeloid leukemia (AML, not the promyelocytic type) has come back once or twice, or did not respond to treatment. Their doctor must consider both strong and gentler treatment possible for them.
- Age
- Older than 18 years.
- Sex
- All sexes can join.
- Disease stage
- Non-APL acute myeloid leukemia in first or second relapse, or refractory, as defined by ELN 2022. WHO 2022 or ICC 2022 criteria are used for the diagnosis.
Main reasons for not taking part
- Known reason the chosen study drug cannot be used (for example allergy or organ failure)
- Taking part in another trial with an investigational drug within 14 days or 5 drug half-lives before randomization
- Active infection or other condition that, in the investigator's opinion, rules out study treatment
- Pregnant or breastfeeding women
- ECOG performance status of 4 or more
Read by machine on 9 November 2026.
Where in Jordan
- King Hussein Cancer CenterAmman, JordanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Trial code
- NCT06713837EU 2024-514517-35-00
- Record updated
- 27 October 2026
- Original description
This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)Read full original descriptionShow less
IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT
This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)
Inclusion: 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:; 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: Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization; 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); Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.