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

Official record

Identifier

NCT06713837

Recruiting locations

countries

CzechiaGermanyItalyLithuaniaPortugalRomaniaSpain

Interventions studied

High intensity therapiesLow intensity therapies

Lead sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Target enrolment

339 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Dec 3, 2024

Last updated on the registry

Aug 14, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Leukemia