{ "data": { "asOf": "2026-10-30T22:27:51.776Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT06713837", "title": "IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.", "scientificTitle": "IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE3" ], "conditions": [ "Acute Myeloid Leukemia", "Relapse/Recurrence" ], "interventions": [ { "name": "High intensity therapies", "type": "DRUG", "description": "* High and intermediate dose Cytarabine\n* Mitoxantrone - Etoposide - Cytarabine (MEC)\n* fludarabine - cytarabine - idarubicin - G-CSF (FLAG-IDA)\n* cladribine - high dose cytarabine (2CDA+HDAraC)\n* mitoxantrone - intermediate dose cytarabine (MiDAC)\n* fludarabine - amsacrine - cytarabine (FLAMSA)\n* Mitoxantrone - Intermediate-dose Cytarabine (HAM)\n* 3+7 (cytarabine and daunorubicine or idarubicine)" }, { "name": "Low intensity therapies", "type": "DRUG", "description": "* Venetoclax+hypomethylating agent (decitabine, azacitidine)\n* Venetoclax+low dose cytarabine\n* Gilteritinib alone or in combination with low dose hypomethylating agent or low dose cytarabine\n* 2CDA 5mg/sqm + low dose cytarabine\n* Glasdegib+low dose cytarabine\n* Ivosidenib alone or in combination with low dose hypomethylating agent or low dose cytarabine\n* Single agent Gemtuzumab or Gemtuzumab in combination with alone or in combination with low dose hypomethylating agent or low dose cytarabine" } ], "sponsor": { "name": "Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS", "type": "OTHER" }, "locations": [ { "city": "Brno", "country": "Czechia", "facility": "University Hospital Brno" }, { "city": "Hradec Králové", "country": "Czechia", "facility": "University Hospital Hradec Králové" }, { "city": "Olomouc", "country": "Czechia", "facility": "University Hospital Olomouc" }, { "city": "Ostrava", "country": "Czechia", "facility": "University Hospital in Ostrava" }, { "city": "Pilsen", "country": "Czechia", "facility": "University Hospital in Pilsen" }, { "city": "Prague", "country": "Czechia", "facility": "Fakultní nemocnice Královské Vinohrady" }, { "city": "Aachen", "country": "Germany", "facility": "Uniklinik RWTH Aachen" }, { "city": "Berlin", "country": "Germany", "facility": "Universitätsmedizin Berlin Charité" }, { "city": "Cologne", "country": "Germany", "facility": "University Hospital Cologne" }, { "city": "Greifswald", "country": "Germany", "facility": "University Hospital Greifswald" }, { "city": "Halle", "country": "Germany", "facility": "Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH" }, { "city": "Halle", "country": "Germany", "facility": "University Hospital Halle" }, { "city": "Rostock", "country": "Germany", "facility": "University Hospital of Rostock" }, { "city": "Zwickau", "country": "Germany", "facility": "Heinrich-Braun-Klinikum gGmbH" }, { "city": "Bologna", "country": "Italy", "facility": "Policlinico Sant'Orsola" }, { "city": "Genova", "country": "Italy", "facility": "IRCCS Ospedale Policlinico San Martino" }, { "city": "Genova", "country": "Italy", "facility": "IRCCS Ospedale Policlinico San Martino" }, { "city": "Palermo", "country": "Italy", "facility": "Ospedali Riuniti Villa Sofia - Cervello" }, { "city": "Pescara", "country": "Italy", "facility": "Ospedale S.Spirito - ASL Pescara" }, { "city": "Perugia", "country": "Italy", "facility": "Ospedale Santa Maria della Misericordia" }, { "city": "Ravenna", "country": "Italy", "facility": "Ospedale Santa Maria delle Croci" }, { "city": "Roma", "country": "Italy", "facility": "Policlinico Tor Vergata" }, { "city": "Roma", "country": "Italy", "facility": "Policlinico Umberto I" }, { "city": "Torino", "country": "Italy", "facility": "AOU Città della Salute e della Scienza di Torino" }, { "city": "Torino", "country": "Italy", "facility": "A. O. Ordine Mauriziano" }, { "city": "Ancona", "country": "Italy", "facility": "Azienda Ospedaliero Universitaria Delle Marche" }, { "city": "Brescia", "country": "Italy", "facility": "ASST degli Spedali Civili" }, { "city": "Busto Arsizio", "country": "Italy", "facility": "ASST Valle Olonda" }, { "city": "Castelfranco Veneto", "country": "Italy", "facility": "Istituto Oncologico Veneto IRCCS" }, { "city": "Florence", "country": "Italy", "facility": "AOU Careggi" }, { "city": "Meldola", "country": "Italy", "facility": "IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori" }, { "city": "Milan", "country": "Italy", "facility": "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico" }, { "city": "Milan", "country": "Italy", "facility": "ASST Grande Ospedale Metropolitano Niguarda" }, { "city": "Naples", "country": "Italy", "facility": "Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli" }, { "city": "Padova", "country": "Italy", "facility": "Azienda Ospedale-Università Padova" }, { "city": "Pavia", "country": "Italy", "facility": "Fondazione IRCCS Policlinico San Matteo" }, { "city": "Piacenza", "country": "Italy", "facility": "Azienda Unita Sanitaria Locale Di Piacenza" }, { "city": "Rimini", "country": "Italy", "facility": "Ospedale Infermi" }, { "city": "San Giovanni Rotondo", "country": "Italy", "facility": "Casa Sollievo Della Sofferenza" }, { "city": "Siena", "country": "Italy", "facility": "Azienda Ospedaliero-Universitaria Senese" }, { "city": "Vicenza", "country": "Italy", "facility": "Ospedale San Bortolo" }, { "city": "Amman", "country": "Jordan", "facility": "King Hussein Cancer Center" }, { "city": "Kaunas", "country": "Lithuania", "facility": "The Hospital of Lithuanian University of Health Sciences Kauno Klinikos" }, { "city": "Lisbon", "country": "Portugal", "facility": "Hospital de Santa Maria" }, { "city": "Bucharest", "country": "Romania", "facility": "Fundeni Clinical Institute" }, { "city": "Albacete", "country": "Spain", "facility": "Hospital General Universitario De Albacete" }, { "city": "Alicante", "country": "Spain", "facility": "Hospital General Universitario Dr. Balmis" }, { "city": "Barcelona", "country": "Spain", "facility": "Hospital Universitari Vall D Hebron" }, { "city": "Valencia", "country": "Spain", "facility": "Hospital Clinico Universitario De Valencia" }, { "city": "Valencia", "country": "Spain", "facility": "Consorcio Hospital General Universitario De Valencia" }, { "city": "Valencia", "country": "Spain", "facility": "Instituto de Investigación Sanitaria La Fe" } ], "outcomes": { "other": [], "primary": [ "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." ], "secondary": [ "To determine if low intensity therapy improves overall survival", "To determine if low intensity therapy improves the overall response (Complete response (CR)/CR with partial hematologic recovery(CRh)/CR with incomplete hematologic recovery(CRi),morphologic leukemia-free state(MLFS))", "To determine if low intensity therapy improves patients-reported quality of life", "To evaluate the safety of low intensity therapies as compared to high intensity therapies" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria\n* 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022\n* Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician\n* Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice\n* No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to:\n\n 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\n* Male or Female, aged\\>18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\<4\n* 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\". 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