Actively Recruiting
IMPACT-AML A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2026-04-08
339
Participants Needed
47
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Lead Sponsor
H
Hospital Vall d'Hebron
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for adults with relapsed or refractory Acute Myeloid Leukemia AML in this multicenter, randomized clinical trial. The study compares high intensity reinduction chemotherapy with low intensity therapies to understand which approach provides better clinical benefit. This trial follows a pragmatic, clinical-oriented design and is funded by the European Commission to address the variability and emerging options in AML treatment. Participants receive either low intensity therapies, which include innovative and targeted drugs alone or combined with less-toxic agents and antibodies, or high intensity treatments involving high-dose chemotherapy agents, also possibly combined with antibodies or targeted drugs. Both treatment approaches are given according to local practice. The study is designed to reflect real-world care and includes patients in their first or second relapse or refractory AML. During the study, participants will be monitored for up to 36 months to assess outcomes such as event-free survival, overall survival, response rates, quality of life, and safety of the treatments. Researchers will collect data on clinical responses and patient-reported outcomes while tracking any side effects. Participants will have regular visits for evaluations and treatment as assigned, with ongoing follow-up to understand the long-term impact of the therapies.
CONDITIONS
Brief Title
IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with non-Acute promyelocytic leukemia (non-APL) AML according to WHO 2022 or ICC 2022 criteria
- Experiencing first or second relapse or refractory AML as defined by European Leukemia Network 2022
- Clinically eligible for both low intensity therapy and high dose chemotherapy as judged by treating physician
- Both treatment options are available and can be provided locally
- No specific treatment protocol considered clearly better suited for patient
- Eastern Cooperative Oncology Group (ECOG) performance status less than 4
- Female participants must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential
- Male participants and their female partners of childbearing potential must use two forms of birth control from screening through 6 months after last treatment
- Willing and able to give informed consent
You will not qualify if you...
- Known contraindications to study drugs including allergies or organ failures
- Participation in another clinical trial with investigational agents within 14 days or 5 drug half-lives before randomization
- Active infections or clinical conditions that make receiving study treatment unsafe or unsuitable according to investigator opinion
Research Team
O
Oriana Nanni
I
Impact-aml coord Impact-aml coord
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