Can gentler therapy beat harsh chemo for tough leukemia?
NCT ID NCT06713837
First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This phase 3 trial tests whether less intense drug combinations can control relapsed or refractory acute myeloid leukemia (AML) as well as high-dose chemotherapy. About 339 adults whose AML has returned or not responded to initial treatment will be randomly assigned to either a low-intensity or high-intensity regimen. The study aims to see which approach improves event-free survival and overall survival with fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- chemotherapy drugs (cytarabine, mitoxantrone, etoposide, fludarabine, idarubicin, cladribine, amsacrine, daunorubicin) and targeted therapies (venetoclax, gilteritinib, azacitidine, decitabine)
- What this could lead to
- If successful, this could show that less intense treatments work as well or better than harsh chemotherapy for relapsed AML, potentially improving quality of life.
- What could go wrong
- This is a large phase 3 trial, but results may not apply to all AML subtypes. Both treatment arms have significant side effects, and the study is open-label, which could introduce bias.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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A. O. Ordine Mauriziano
RECRUITINGTorino, TO, 10128, Italy
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AOU Careggi
RECRUITINGFlorence, 50019, Italy
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AOU Città della Salute e della Scienza di Torino
RECRUITINGTorino, TO, 10126, Italy
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ASST Grande Ospedale Metropolitano Niguarda
NOT_YET_RECRUITINGMilan, 20162, Italy
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ASST Valle Olonda
RECRUITINGBusto Arsizio, 21052, Italy
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ASST degli Spedali Civili
RECRUITINGBrescia, 25123, Italy
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Azienda Ospedale-Università Padova
RECRUITINGPadova, 35100, Italy
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Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
NOT_YET_RECRUITINGNaples, 80131, Italy
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Azienda Ospedaliero Universitaria Delle Marche
RECRUITINGAncona, 60126, Italy
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Azienda Ospedaliero-Universitaria Senese
RECRUITINGSiena, 53100, Italy
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Azienda Unita Sanitaria Locale Di Piacenza
RECRUITINGPiacenza, 29121, Italy
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Casa Sollievo Della Sofferenza
RECRUITINGSan Giovanni Rotondo, 71013, Italy
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Consorcio Hospital General Universitario De Valencia
NOT_YET_RECRUITINGValencia, 46014, Spain
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
RECRUITINGMilan, 20122, Italy
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Fondazione IRCCS Policlinico San Matteo
NOT_YET_RECRUITINGPavia, 27100, Italy
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Fundeni Clinical Institute
RECRUITINGBucharest, 022328, Romania
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Heinrich-Braun-Klinikum gGmbH
RECRUITINGZwickau, 08060, Germany
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Hospital Clinico Universitario De Valencia
NOT_YET_RECRUITINGValencia, 46010, Spain
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Hospital General Universitario De Albacete
NOT_YET_RECRUITINGAlbacete, 02006, Spain
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Hospital General Universitario Dr. Balmis
RECRUITINGAlicante, 03010, Spain
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Hospital Universitari Vall D Hebron
NOT_YET_RECRUITINGBarcelona, 08035, Spain
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Hospital de Santa Maria
RECRUITINGLisbon, 1649-035, Portugal
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IRCCS Ospedale Policlinico San Martino
NOT_YET_RECRUITINGGenova, GE, 16132, Italy
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IRCCS Ospedale Policlinico San Martino
RECRUITINGGenova, GE, 16132, Italy
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IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
RECRUITINGMeldola, 47014, Italy
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Instituto de Investigación Sanitaria La Fe
RECRUITINGValencia, 46026, Spain
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Istituto Oncologico Veneto IRCCS
RECRUITINGCastelfranco Veneto, 31033, Italy
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Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
RECRUITINGHalle, 06110, Germany
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Ospedale Infermi
RECRUITINGRimini, 47923, Italy
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Ospedale S.Spirito - ASL Pescara
NOT_YET_RECRUITINGPescara, PE, 65124, Italy
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Ospedale San Bortolo
RECRUITINGVicenza, 36100, Italy
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Ospedale Santa Maria della Misericordia
RECRUITINGPerugia, PG, 06156, Italy
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Ospedale Santa Maria delle Croci
RECRUITINGRavenna, RA, 48121, Italy
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Ospedali Riuniti Villa Sofia - Cervello
RECRUITINGPalermo, PA, 90146, Italy
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Policlinico Sant'Orsola
RECRUITINGBologna, BO, 40138, Italy
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Policlinico Tor Vergata
RECRUITINGRoma, RM, 00133, Italy
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Policlinico Umberto I
RECRUITINGRoma, RM, 00161, Italy
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The Hospital of Lithuanian University of Health Sciences Kauno Klinikos
RECRUITINGKaunas, 50161, Lithuania
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Uniklinik RWTH Aachen
RECRUITINGAachen, 52074, Germany
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University Hospital Brno
RECRUITINGBrno, 625 00, Czechia
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University Hospital Greifswald
RECRUITINGGreifswald, 17475, Germany
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University Hospital Halle
RECRUITINGHalle, 06120, Germany
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University Hospital Hradec Králové
NOT_YET_RECRUITINGHradec Králové, 500 05, Czechia
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University Hospital Olomouc
NOT_YET_RECRUITINGOlomouc, 779 00, Czechia
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University Hospital in Ostrava
NOT_YET_RECRUITINGOstrava, 708 00, Czechia
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University Hospital in Pilsen
RECRUITINGPilsen, 323 00, Czechia
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University Hospital of Rostock
RECRUITINGRostock, 18507, Germany
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