Phase 3 Leukaemia Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with a specific type of blood cancer called AML (acute myeloid leukemia), but not the subtype called APL (acute promyelocytic leukemia), diagnosed using 2022 international medical standards
- People whose AML has come back for the first or second time, or whose AML did not respond to previous treatment, based on 2022 European leukemia guidelines
- People whose treating doctor considers them medically suitable for either a lower-intensity treatment approach or a stronger, high-dose chemotherapy approach
- People for whom both the lower-intensity and high-dose chemotherapy options are practically available at their treatment centre
- People for whom no single treatment option is clearly the better or only standard choice — meaning there is no proven superior drug available, no medical reason to avoid either treatment option, no personal preference against either option, and no practical barriers (such as lack of support at home) that would make one option impossible
- Adults aged 18 or older
- People with a general health and activity level rated below the most severely limited category on a standard medical scale (ECOG score of 3 or below)
- Women who are not pregnant and not breastfeeding; women who could potentially become pregnant must have a negative pregnancy test within 14 days of starting treatment and must use highly effective contraception from the screening visit until 6 months after the last dose of the study treatment
- Men with a partner who could potentially become pregnant must use two forms of contraception (including a condom) from the screening visit until 6 months after the last dose of the study treatment
- People who are willing and able to provide written informed consent to take part in the study
Who may not be able to join:
- People who have a known medical reason why they cannot take the specific study treatment their doctor would select, such as a severe allergy, hypersensitivity reaction, or organ problems that would make the treatment unsafe
- People who have taken part in another clinical trial using an experimental treatment within the 14 days before joining this trial, or within 5 half-lives of that experimental drug — whichever comes first
- People who have an active infection or other medical condition that, in the treating doctor's judgement, makes it unsafe for them to receive the study treatment
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Giovanni Martinelli, MD, Prof, University of Bologna
Phone: +39 0543739100
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
To determine in R/R AML patients the clinical benefit of low intensity therapy as shown by event-free survival compared to high intensity therapy.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.