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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital Brno
  Brno, Czechia Recruiting
• University Hospital in Pilsen
  Pilsen, Czechia Recruiting
• Fakultní nemocnice Královské Vinohrady
  Prague, Czechia Recruiting
• Uniklinik RWTH Aachen
  Aachen, Germany Recruiting
• University Hospital Greifswald
  Greifswald, Germany Recruiting
• Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
  Halle, Germany Recruiting

+1 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Oriana Nanni
• Email: cc.ubsc@irst.emr.it
• Phone: +39 0543739100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.