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 type | Observational |
|---|---|
| Ages | 6 Years and up |
| Sex | All |
| Enrollment | 4000 (estimated) |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Academic / other |
| Locations | 41 sites (Aachen and 40 other locations) |
| Status | Recruiting |
| Started | June 28, 2024 |
| Main results expected | July 2032 |
| Study ends | July 2032 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT06459024 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
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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
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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
- Study coordinator: Oriana Nanni
- Email: cc.ubsc@irst.emr.it
- Phone: +39 0543 739100
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Combining cytokine-induced memory-like natural killer cells with atezolizumab for relapsed or refractory AML
This trial will test whether giving cytokine-induced memory-like natural killer cells together with atezolizumab is safe and might help adults with relapsed or refractory acute myeloid leukemia.
-
Treatment with ARD103 CAR-T therapy for patients with relapsed or refractory AML or MDS
This study is testing a new CAR-T therapy called ARD103 to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia or myelodysplastic syndrome.
-
Investigating APL-4098 with Azacitidine for treating relapsed or refractory AML and high-risk MDS
This study is testing a new treatment called APL-4098, alone and with azacitidine, to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia and high-risk myelodysplastic syndrome.
-
Using off-the-shelf CAR-NK cells to treat relapsed or refractory acute myeloid leukemia
This study is testing a new treatment using specially modified immune cells to see if they can help people with relapsed or hard-to-treat acute myeloid leukemia feel better.
-
Using CAR-T cell therapy targeting Tim-3 and CD123 for treating relapsed acute myeloid leukemia
This study is testing a new CAR-T cell therapy that targets specific markers in people aged 18-70 with relapsed acute myeloid leukemia to see if it can safely improve their treatment outcomes.
-
Using CAR T cells to treat acute myeloid leukemia
This study is testing a new treatment using specially modified CAR T cells to see if it can safely help adults and kids with tough cases of acute myeloid leukemia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.