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RECRUITING
NCT06713837
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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)

DRUG

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