Actively Recruiting
IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2026-04-08
339
Participants Needed
47
Research Sites
148 weeks
Total Duration
On this page
Sponsors
I
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Lead Sponsor
H
Hospital Vall d'Hebron
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of non-Acute promyelocytic leukemia (APL) AML according to WHO 2022 or ICC 2022 criteria
- In first or second relapse or refractory status based on ELN 2022
- Clinically suitable for both low intensity therapy and high dose chemotherapy as assessed by physician
- Both treatment options available and can be provided locally
- No specific treatment protocol clearly better suited for patient needs
- Male or female aged over 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status less than 4
- Female participants must not be pregnant or breastfeeding and must have negative pregnancy test if of childbearing potential
- Women of childbearing potential must use highly effective birth control methods from screening until 6 months after last treatment
- Male participants and their female partners of childbearing potential must use two methods of birth control from screening until 6 months after last treatment
- Willing and able to provide informed consent for study participation
You will not qualify if you...
- Known contraindications to selected study drugs, including allergies or organ failure
- Participation in another clinical trial involving investigational agents within 14 days or 5 drug half-lives before randomization
- Active infections or other clinical conditions making the patient unsuitable for study treatment according to investigator assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 47 locations
1
University Hospital Brno
Brno, Czechia, 625 00
Actively Recruiting
2
University Hospital Hradec Králové
Hradec Králové, Czechia, 500 05
Not Yet Recruiting
3
University Hospital Olomouc
Olomouc, Czechia, 779 00
Not Yet Recruiting
4
University Hospital in Ostrava
Ostrava, Czechia, 708 00
Not Yet Recruiting
5
University Hospital in Pilsen
Pilsen, Czechia, 323 00
Not Yet Recruiting
6
Uniklinik RWTH Aachen
Aachen, Germany, 52074
Actively Recruiting
7
University Hospital Greifswald
Greifswald, Germany, 17475
Actively Recruiting
8
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, Germany, 06110
Not Yet Recruiting
9
University Hospital Halle
Halle, Germany, 06120
Actively Recruiting
10
University Hospital of Rostock
Rostock, Germany, 18507
Actively Recruiting
11
Heinrich-Braun-Klinikum gGmbH
Zwickau, Germany, 08060
Not Yet Recruiting
12
Policlinico Sant'Orsola
Bologna, BO, Italy, 40138
Actively Recruiting
13
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy, 16132
Not Yet Recruiting
14
IRCCS Ospedale Policlinico San Martino
Genova, GE, Italy, 16132
Not Yet Recruiting
15
Ospedali Riuniti Villa Sofia - Cervello
Palermo, PA, Italy, 90146
Actively Recruiting
16
Ospedale S.Spirito - ASL Pescara
Pescara, PE, Italy, 65124
Not Yet Recruiting
17
Ospedale Santa Maria della Misericordia
Perugia, PG, Italy, 06156
Actively Recruiting
18
Ospedale Santa Maria delle Croci
Ravenna, RA, Italy, 48121
Actively Recruiting
19
Policlinico Tor Vergata
Roma, RM, Italy, 00133
Actively Recruiting
20
Policlinico Umberto I
Roma, RM, Italy, 00161
Actively Recruiting
21
AOU Città della Salute e della Scienza di Torino
Torino, TO, Italy, 10126
Actively Recruiting
22
A. O. Ordine Mauriziano
Torino, TO, Italy, 10128
Actively Recruiting
23
Azienda Ospedaliero Universitaria Delle Marche
Ancona, Italy, 60126
Not Yet Recruiting
24
ASST degli Spedali Civili
Brescia, Italy, 25123
Actively Recruiting
25
ASST Valle Olonda
Busto Arsizio, Italy, 21052
Actively Recruiting
26
Istituto Oncologico Veneto IRCCS
Castelfranco Veneto, Italy, 31033
Actively Recruiting
27
AOU Careggi
Florence, Italy, 50019
Actively Recruiting
28
IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, Italy, 47014
Actively Recruiting
29
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
30
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy, 20162
Not Yet Recruiting
31
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Naples, Italy, 80131
Not Yet Recruiting
32
Azienda Ospedale-Università Padova
Padova, Italy, 35100
Actively Recruiting
33
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Not Yet Recruiting
34
Azienda Unita Sanitaria Locale Di Piacenza
Piacenza, Italy, 29121
Not Yet Recruiting
35
Ospedale Infermi
Rimini, Italy, 47923
Actively Recruiting
36
Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Italy, 71013
Not Yet Recruiting
37
Azienda Ospedaliero-Universitaria Senese
Siena, Italy, 53100
Not Yet Recruiting
38
Ospedale San Bortolo
Vicenza, Italy, 36100
Actively Recruiting
39
The Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, Lithuania, 50161
Actively Recruiting
40
Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
41
Fundeni Clinical Institute
Bucharest, Romania, 022328
Actively Recruiting
42
Hospital General Universitario De Albacete
Albacete, Spain, 02006
Not Yet Recruiting
43
Hospital General Universitario Dr. Balmis
Alicante, Spain, 03010
Not Yet Recruiting
44
Hospital Universitari Vall D Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
45
Hospital Clinico Universitario De Valencia
Valencia, Spain, 46010
Not Yet Recruiting
46
Consorcio Hospital General Universitario De Valencia
Valencia, Spain, 46014
Not Yet Recruiting
47
Instituto de Investigación Sanitaria La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
O
Oriana Nanni
CONTACT
I
Impact-aml coord Impact-aml coord
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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