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

PHASE3RecruitingINTERVENTIONAL
Enrollment

339

Participants

Timeline

Start Date

February 27, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
Acute Myeloid LeukemiaRelapse/Recurrence
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"

Trial Locations (34)

10126

NOT_YET_RECRUITING

AOU Città della Salute e della Scienza di Torino, Torino

10128

RECRUITING

A. O. Ordine Mauriziano, Torino

16132

NOT_YET_RECRUITING

IRCCS Ospedale Policlinico San Martino, Genova

NOT_YET_RECRUITING

IRCCS Ospedale Policlinico San Martino, Genova

17475

RECRUITING

University Hospital Greifswald, Greifswald

18507

RECRUITING

University Hospital of Rostock, Rostock

20122

NOT_YET_RECRUITING

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

20162

NOT_YET_RECRUITING

ASST Grande Ospedale Metropolitano Niguarda, Milan

21052

NOT_YET_RECRUITING

ASST Valle Olonda, Busto Arsizio

25123

NOT_YET_RECRUITING

ASST degli Spedali Civili, Brescia

31033

RECRUITING

Istituto Oncologico Veneto IRCCS, Castelfranco Veneto

35100

NOT_YET_RECRUITING

Azienda Ospedale-Università Padova, Padua

36100

RECRUITING

Ospedale San Bortolo, Vicenza

40138

RECRUITING

Policlinico Sant'Orsola, Bologna

46026

RECRUITING

Instituto de Investigación Sanitaria La Fe, Valencia

47014

RECRUITING

IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori, Meldola

47923

RECRUITING

Ospedale Infermi, Rimini

48121

RECRUITING

Ospedale Santa Maria delle Croci, Ravenna

50019

RECRUITING

AOU Careggi, Florence

50161

RECRUITING

The Hospital of Lithuanian University of Health Sciences Kauno Klinikos, Kaunas

65124

NOT_YET_RECRUITING

Ospedale S.Spirito - ASL Pescara, Pescara

80131

NOT_YET_RECRUITING

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli, Napoli

90146

RECRUITING

Ospedali Riuniti Villa Sofia - Cervello, Palermo

625 00

NOT_YET_RECRUITING

University Hospital Brno, Brno

500 05

NOT_YET_RECRUITING

University Hospital Hradec Králové, Hradec Králové

779 00

NOT_YET_RECRUITING

University Hospital Olomouc, Olomouc

708 00

NOT_YET_RECRUITING

University Hospital in Ostrava, Ostrava

323 00

NOT_YET_RECRUITING

University Hospital in Pilsen, Pilsen

06120

RECRUITING

University Hospital Halle, Halle

06156

RECRUITING

Ospedale Santa Maria della Misericordia, Perugia

00133

NOT_YET_RECRUITING

Policlinico Tor Vergata, Roma

00161

RECRUITING

Policlinico Umberto I, Roma

1649-035

NOT_YET_RECRUITING

Hospital de Santa Maria, Lisbon

022328

RECRUITING

Fundeni Clinical Institute, Bucharest

All Listed Sponsors
collaborator

Hospital Vall d'Hebron

OTHER

collaborator

Cyprus Institute of Neurology and Genetics

OTHER

collaborator

European Leukemia Net

UNKNOWN

collaborator

Fundacion Para La Investigacion Hospital La Fe

OTHER

collaborator

Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V.

UNKNOWN

collaborator

Ospedale Pediatrico Bambin Gesù

OTHER

collaborator

Czech Lymphoma Study Group

OTHER

collaborator

Charite University, Berlin, Germany

OTHER

collaborator

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

OTHER

collaborator

University of Bologna

OTHER

collaborator

Hannover Medical School

OTHER

collaborator

German Society for Pediatric Oncology and Hematology GPOH gGmbH

OTHER

collaborator

Toscana Life Sciences Sviluppo s.r.l.

INDUSTRY

collaborator

Lithuanian University of Health Sciences

OTHER

collaborator

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

collaborator

TIMELEX

UNKNOWN

lead

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

OTHER