Framework for managing relapsed or refractory acute myeloid leukemia
Master Framework For Relapse or Refractory Acute Myeloid Leukemia- IMPACT STREAM - A Prospective Observational Study of Treatment Outcomes
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · NCT06459024
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 |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS (other) |
| Locations | 38 sites (Aachen and 37 other locations) |
| Trial ID | NCT06459024 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with acute myeloid leukemia who have experienced treatment failure, including relapse or refractory disease.
Not a fit: Patients currently enrolled in other clinical trials may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aachen and 37 other locations
- 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)
- 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)
- Presidio Ospedaliero "Santo Spirito" — Pescara, PE, Italy (NOT_YET_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 (NOT_YET_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)
- 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)
- AOU Maggiore della Carità — Novara, Italy (RECRUITING)
- Azienda Ospedale-Università Padova — Padova, Italy (NOT_YET_RECRUITING)
- Ospedale San Bortolo — Vicenza, Italy (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)
Study contacts
- Study coordinator: Oriana Nanni
- Email: cc.ubsc@irst.emr.it
- Phone: +39 0543 739100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory, Relapsed, Refractory, Acute Myeloid Leukemia, Framework