Clinical trial Recruiting at 40 sites Observational Ages 6 and up

Framework for managing relapsed or refractory acute myeloid leukemia

Official title: Master Framework For Relapse or Refractory Acute Myeloid Leukemia- IMPACT STREAM - A Prospective Observational Study of Treatment Outcomes

Run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · NCT06459024 · Data updated 2026-11-12

This study is trying to see how well new personalized treatments work for people in Europe with relapsed or refractory acute myeloid leukemia to help improve their care.

Quick facts

Study typeObservational
Ages6 Years and up
SexAll
Enrollment4000 (estimated)
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Academic / other
Locations41 sites (Aachen and 40 other locations)
StatusRecruiting
StartedJune 28, 2024
Main results expectedJuly 2032
Study endsJuly 2032
Registry record updatedOctober 27, 2026
Trial IDNCT06459024 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with acute myeloid leukemia who have experienced treatment failure, including relapse or refractory disease.

Probably not a fit

Patients currently enrolled in other clinical trials may not benefit from this study.

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

What this trial studies

This observational cohort study aims to collect data from patients diagnosed with relapsed or refractory acute myeloid leukemia (AML) across various clinical sites in Europe. The study seeks to monitor treatment outcomes and efficacy of new personalized therapies in real-world settings, addressing the significant challenges faced by patients with this hard-to-treat disease. By creating a master framework, the study will facilitate better understanding and management of R/R AML, contributing to improved patient care and treatment strategies. The initiative is part of the Horizon Europe Mission Cancer 2022 IMPACT-AML project, in collaboration with the European Reference Network on Rare Hematological Diseases.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with relapsed or refractory acute myeloid leukemia.

How similar studies have gone: Other studies have shown success in collecting real-world data for similar conditions, but this framework represents a novel approach to standardizing data collection for R/R AML.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with AML diagnosis according to WHO2022 or ICC2022
* Treatment failure (i.e. relapse, refractory or progression, including MRD) according to ELN2022 criteria
* Participant or his/her legal representative is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Patients included in clinical trials may be enrolled except where otherwise specified in the experimental protocol.

Where it's running

  • University Hospital Aachen
    Aachen, Germany
    Recruiting
  • University Hospital Greifswald
    Greifswald, Germany
    Recruiting
  • University Hospital Halle
    Halle, Germany
    Recruiting
  • University Hospital of Rostock
    Rostock, Germany
    Recruiting
  • Policlinico Sant'Orsola-Malpighi
    Bologna, Bo, Italy
    Recruiting
  • Ospedale "A. Perrino"
    Brindisi, Br, Italy
    Recruiting
Show 35 more locations
  • ASST Spedali Civili
    Brescia, Bs, Italy
    Recruiting
  • Azienda Ospedaliera S. Croce e Carle
    Cuneo, Cn, Italy
    Recruiting
  • Ospedale Valduce
    Como, Co, Italy
    Recruiting
  • ASST Cremona
    Cremona, Cr, Italy
    Recruiting
  • AOU Universitaria Arcispedale Sant'Anna
    Ferrara, Fe, Italy
    Recruiting
  • IRCCS Ospedale Policlinico San Martino
    Genova, Ge, Italy
    Recruiting
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
    Milan, Mi, Italy
    Recruiting
  • ASST Grande Ospedale Metropolitano Niguarda
    Milan, Mi, Italy
    Recruiting
  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
    Palermo, PA, Italy
    Recruiting
  • Ospedale Santa Maria della Misericordia
    Perugia, Pg, Italy
    Recruiting
  • Ospedale Santa Maria delle Croci
    Ravenna, Ra, Italy
    Recruiting
  • Fondazione Policlinico Tor Vergata
    Roma, Rm, Italy
    Recruiting
  • Policlinico Umberto I
    Roma, Rm, Italy
    Recruiting
  • Policlinico Universitario Fondazione Agostino Gemelli
    Roma, Rm, Italy
    Recruiting
  • Ospedale Sant'Andrea
    Roma, Rm, Italy
    Recruiting
  • Ospedale infermi di Rimini
    Rimini, Rn, Italy
    Recruiting
  • AOU San Giovanni di Dio e Ruggi d'Aragona
    Salerno, Sa, Italy
    Recruiting
  • AOU Città della Salute e della Scienza di Torino
    Torino, To, Italy
    Recruiting
  • AO Ordine Mauriziano
    Torino, To, Italy
    Recruiting
  • IOV Istituto Oncologico Veneto
    Castelfranco Veneto, Tv, Italy
    Recruiting
  • ASST Valle Olona
    Busto Arsizio, VA, Italy
    Recruiting
  • Azienda Ospedaliero Universitaria Delle Marche
    Ancona, Italy
    Recruiting
  • AOU Careggi
    Florence, Italy
    Recruiting
  • IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
    Meldola, Italy
    Recruiting
  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
    Naples, Italy
    Recruiting
  • Azienda Ospeldaliera Universitaria Federico II
    Naples, Italy
    Recruiting
  • AOU Maggiore della Carità
    Novara, Italy
    Recruiting
  • Azienda Ospedale-Università Padova
    Padova, Italy
    Recruiting
  • Ospedale San Bortolo
    Vicenza, Italy
    Recruiting
  • King Hussein Cancer Center
    Amman, Jordan
    Recruiting
  • The Hospital of Lithuanian University of Health Sciences Kauno Klinikos
    Kaunas, Lithuania
    Recruiting
  • University Clinical Center in Gdańsk
    Gdansk, Poland
    Recruiting
  • Fundeni Clinical Institute
    Bucharest, Romania
    Recruiting
  • University Hospital La Fe
    Valencia, Spain
    Recruiting
  • Presidio Ospedaliero "Santo Spirito"
    Pescara, Pe, Italy
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.