RecruitingPhase 3NCT06713837

IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.

IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT

Sponsor

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Enrollment

339 participants

Start Date

Feb 27, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Relapse/Recurrence

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)

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This randomized pragmatic trial compares intensive chemotherapy versus lower-intensity therapy in patients with relapsed or refractory acute myeloid leukemia (AML) to determine the best treatment approach when either option is medically reasonable. **You may be eligible if...** - You have acute myeloid leukemia (not the APL subtype) that has relapsed (1st or 2nd relapse) or is refractory to treatment - Your doctor believes you are medically suitable for both intensive chemotherapy and lower-intensity therapy - Both treatment options are available at your center - No specific protocol is clearly superior for your situation **You may NOT be eligible if...** - You have acute promyelocytic leukemia (APL) - You are not considered a suitable candidate for either treatment intensity - A specific treatment option is clearly better suited to your individual situation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHigh 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)

DRUGLow 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

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NCT06713837

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