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IMPACT-AML: A RANDOMIZED PRAGMATIC CLINICAL TRIAL FOR RELAPSE OR REFRACTORY ACUTE MYELOID LEUKEMIA
EU CTIS ID: 2024-514517-35-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Non-APL AML defined according WHO 2022 (or ICC 2022) criteria
- 1st or 2nd relapse or refractory according to ELN 2022
- Patient is clinically candidate both to low intensity therapy and to 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
You likely can't join if
- 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 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.
See the full eligibility criteria
Who can join
- Non-APL AML defined according WHO 2022 (or ICC 2022) criteria
- 1st or 2nd relapse or refractory according to ELN 2022
- Patient is clinically candidate both to low intensity therapy and to 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
- 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
What rules you out
- 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 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.