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IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.
Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Summary
This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)
Official title: IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
339
Start Date
2025-02-27
Completion Date
2028-01
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
High intensity therapies
* High and intermediate dose Cytarabine * Mitoxantrone - Etoposide - Cytarabine (MEC) * fludarabine - cytarabine - idarubicin - G-CSF (FLAG-IDA) * cladribine - high dose cytarabine (2CDA+HDAraC) * mitoxantrone - intermediate dose cytarabine (MiDAC) * fludarabine - amsacrine - cytarabine (FLAMSA) * Mitoxantrone - Intermediate-dose Cytarabine (HAM) * 3+7 (cytarabine and daunorubicine or idarubicine)
Low intensity therapies
* Venetoclax+hypomethylating agent (decitabine, azacitidine) * Venetoclax+low dose cytarabine * Gilteritinib alone or in combination with low dose hypomethylating agent or low dose cytarabine * 2CDA 5mg/sqm + low dose cytarabine * Glasdegib+low dose cytarabine * Ivosidenib alone or in combination with low dose hypomethylating agent or low dose cytarabine * Single agent Gemtuzumab or Gemtuzumab in combination with alone or in combination with low dose hypomethylating agent or low dose cytarabine
Locations (47)
University Hospital Brno
Brno, Czechia
University Hospital Hradec Králové
Hradec Králové, Czechia
University Hospital Olomouc
Olomouc, Czechia
University Hospital in Ostrava
Ostrava, Czechia
University Hospital in Pilsen
Pilsen, Czechia
Uniklinik RWTH Aachen
Aachen, Germany
University Hospital Greifswald
Greifswald, Germany
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, Germany
University Hospital Halle
Halle, Germany
University Hospital of Rostock
Rostock, Germany
Heinrich-Braun-Klinikum gGmbH
Zwickau, Germany
Policlinico Sant'Orsola
Bologna, BO, Italy
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy
Ospedali Riuniti Villa Sofia - Cervello
Palermo, PA, Italy
Ospedale S.Spirito - ASL Pescara
Pescara, PE, Italy
Ospedale Santa Maria della Misericordia
Perugia, PG, Italy
Ospedale Santa Maria delle Croci
Ravenna, RA, Italy
Policlinico Tor Vergata
Roma, RM, Italy
Policlinico Umberto I
Roma, RM, Italy
AOU Città della Salute e della Scienza di Torino
Torino, TO, Italy
A. O. Ordine Mauriziano
Torino, TO, Italy
Azienda Ospedaliero Universitaria Delle Marche
Ancona, Italy
ASST degli Spedali Civili
Brescia, Italy
ASST Valle Olonda
Busto Arsizio, Italy
Istituto Oncologico Veneto IRCCS
Castelfranco Veneto, Italy
AOU Careggi
Florence, Italy
IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Naples, Italy
Azienda Ospedale-Università Padova
Padova, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Azienda Unita Sanitaria Locale Di Piacenza
Piacenza, Italy
Ospedale Infermi
Rimini, Italy
Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy
Azienda Ospedaliero-Universitaria Senese
Siena, Italy
Ospedale San Bortolo
Vicenza, Italy
The Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, Lithuania
Hospital de Santa Maria
Lisbon, Portugal
Fundeni Clinical Institute
Bucharest, Romania
Hospital General Universitario De Albacete
Albacete, Spain
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitari Vall D Hebron
Barcelona, Spain
Hospital Clinico Universitario De Valencia
Valencia, Spain
Consorcio Hospital General Universitario De Valencia
Valencia, Spain
Instituto de Investigación Sanitaria La Fe
Valencia, Spain