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Acute Myeloid LeukemiaPhase 3IMPACT-AMLNCT06713837

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

A Phase 3 study testing High intensity therapies and Low intensity therapies in people with Acute Myeloid Leukemia and Relapse/Recurrence, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 47 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia, Relapse/Recurrence
What is being tested?
High intensity therapies and Low intensity therapies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
339 participants
Where
47 sitesin 7 countries
Study dates
27 Feb 2025to Jan 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria
  • 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022
  • Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician
  • Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice
  • No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to:
  • the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization
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  • Male or Female, aged>18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status <4
  • A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials". Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials". Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.
  • Participant is willing and able to give informed consent for participation in the study

Who cannot join

  • Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of Summary of Product Characteristics (SmPC) (e.g. hypersensitivity, allergy, organ failure precluding treatment)
  • Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization
  • Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.

Trial locations and contacts

47 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Oriana Nanni contact

+39 0543739100

cc.ubsc@irst.emr.it

Impact-aml coord Impact-aml coord contact

impact-aml@irst.emr.it

47 sites in 7 countries

Italy27 sites, 27 recruiting

  • Azienda Ospedaliero Universitaria Delle Marche

    Ancona, 60126

    Lorenzo Brunetti, MD

    Recruiting

  • Policlinico Sant'Orsola

    Bologna, BO, 40138

    Antonio Curti, MD

    Recruiting

  • ASST degli Spedali Civili

    Brescia, 25123

    Erika Borlenghi, MD

    Recruiting

  • ASST Valle Olonda

    Busto Arsizio, 21052

    Elisabetta Todisco, MD

    Recruiting

  • Istituto Oncologico Veneto IRCCS

    Castelfranco Veneto, 31033

    Alessandra Sperotto, MD

    Recruiting

  • AOU Careggi

    Florence, 50019

    Francesco Mannelli, MD

    Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova, GE, 16132

    Marica Laurino, MD

    Not yet recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova, GE, 16132

    Fabio Guolo, MD

    Recruiting

  • IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola, 47014

    Maria Benedetta Giannini, MD

    Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Nicola Stefano Fracchiolla, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Valentina Mancini, MD

    Not yet recruiting

  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

    Naples, 80131

    Mario Annunziata, MD

    Not yet recruiting

  • Azienda Ospedale-Università Padova

    Padova, 35100

    Federica Lessi, MD

    Recruiting

  • Ospedali Riuniti Villa Sofia - Cervello

    Palermo, PA, 90146

    Antonino Mulè, MD

    Recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Patrizia Zappasodi, MD

    Not yet recruiting

  • Ospedale Santa Maria della Misericordia

    Perugia, PG, 06156

    Maria Paola Martelli, MD

    Recruiting

  • Ospedale S.Spirito - ASL Pescara

    Pescara, PE, 65124

    Prassede Salutari

    Not yet recruiting

  • Azienda Unita Sanitaria Locale Di Piacenza

    Piacenza, 29121

    Lara Pochintesta, MD

    Recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna, RA, 48121

    Giovanni Marconi, MD

    Recruiting

  • Ospedale Infermi

    Rimini, 47923

    Anna Maria Mianulli, MD

    Recruiting

  • Policlinico Tor Vergata

    Roma, RM, 00133

    Adriano Venditti, MD

    Recruiting

  • Policlinico Umberto I

    Roma, RM, 00161

    Saveria Capria, MD

    Recruiting

  • Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, 71013

    Giovanni Rossi, MD

    Recruiting

  • Azienda Ospedaliero-Universitaria Senese

    Siena, 53100

    Monica Bocchia, MD

    Recruiting

  • AOU Città della Salute e della Scienza di Torino

    Torino, TO, 10126

    Ernesta Audisio, MD

    Recruiting

  • A. O. Ordine Mauriziano

    Torino, TO, 10128

    Daniela Cilloni, MD

    Recruiting

  • Ospedale San Bortolo

    Vicenza, 36100

    Davide Facchinelli, MD

    Recruiting

Other trials in Italy

Germany6 sites, 6 recruiting

  • Uniklinik RWTH Aachen

    Aachen, 52074

    Martina Crysandt, MD

    Recruiting

  • University Hospital Greifswald

    Greifswald, 17475

    Adrian Schwarzer, MD

    Recruiting

  • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH

    Halle, 06110

    Kinga Ligeti, MD

    Recruiting

  • University Hospital Halle

    Halle, 06120

    Judith Schaffrath, MD

    Recruiting

  • University Hospital of Rostock

    Rostock, 18507

    Christian Junghanß, MD

    Recruiting

  • Heinrich-Braun-Klinikum gGmbH

    Zwickau, 08060

    Sara Hilber, MD

    Recruiting

Other trials in Germany

Spain6 sites, 6 recruiting

  • Hospital General Universitario De Albacete

    Albacete, 02006

    Jesús Lorenzo Algarra, MD

    Not yet recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

    Carmen Botella Prieto, MD

    Recruiting

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035

    Olga Salamero, MD

    Not yet recruiting

  • Hospital Clinico Universitario De Valencia

    Valencia, 46010

    Maria del Mar Tormo Díaz, MD

    Not yet recruiting

  • Consorcio Hospital General Universitario De Valencia

    Valencia, 46014

    Armando Mena Duran, MD

    Not yet recruiting

  • Instituto de Investigación Sanitaria La Fe

    Valencia, 46026

    Pau Montesinos, MD

    Recruiting

Other trials in Spain

Czechia5 sites, 5 recruiting

  • University Hospital Brno

    Brno, 625 00

    Jiri Mayer, Prof.

    Recruiting

  • University Hospital Hradec Králové

    Hradec Králové, 500 05

    Pavel Žák, MD

    Not yet recruiting

  • University Hospital Olomouc

    Olomouc, 779 00

    Tomáš Szotkowski, MD

    Not yet recruiting

  • University Hospital in Ostrava

    Ostrava, 708 00

    Zdeněk Kořístek,, MD

    Not yet recruiting

  • University Hospital in Pilsen

    Pilsen, 323 00

    Pavel Jindra, MD

    Recruiting

Other trials in Czechia

Lithuania1 site, 1 recruiting

  • The Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, 50161

    Rolandas Gerbutavičius, MD

    Recruiting

Other trials in Lithuania

Portugal1 site, 1 recruiting

  • Hospital de Santa Maria

    Lisbon, 1649-035

    Joana Brioso Infante, MD

    Recruiting

Other trials in Portugal

Romania1 site, 1 recruiting

  • Fundeni Clinical Institute

    Bucharest, 022328

    Daniel Coriu, MD

    Recruiting

Other trials in Romania

About this study

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

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)

Read the detailed description

Thanks to recent advantages and results that demonstrate that low-intensity rescues may be quantitatively comparable to chemotherapy, novel personalized therapies are being slowly integrated into the treatment options of R/R AML. These new strategies, for the high interpatient variability, for the different cross-country reimbursement, for the school of thinking of treatment physicians, will wait decades to be proficiently compared with standard chemotherapy in the R/R setting, especially because most of the novel drugs are being pushed by the companies in the front-line (a setting that still has a large room for improvements). In IMPACT-AML RPCT, low-intensity therapies will be compared with high intensity chemotherapy rescue following a pragmatic, clinical-oriented approach. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)

Being tested
High intensity therapies, Low intensity therapies
Keywords
Relapsed/Refractory, Acute Myeloid Leukemia, Low Intensity therapy, Pragmatic, Low intervention Clinical trial, Randomized controlled trial, Horizon Europe, Mission Cancer, Diagnosis and treatment
Medical subject headings
Leukemia, Myeloid, Acute, Recurrence, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High intensity therapiesDrug

    • 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)

  • Low intensity therapiesDrug

    • 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
Study groups in NCT06713837
Study groupRoleWhat they receive
Low intensity treatmentExperimentalLow intensity treatments are based on the single agent use of innovative and target drugs or their combination with other target drugs and less-toxic agents in doublets or triplets. Administration of low intensity therapies in combination with antibodies or target agents would be included in this cohort
Receives: Drug: Low intensity therapies
High intensity treatmentActive comparatorIntensive treatment of leukemia is based on high dose of chemotherapy agents. Administration of high-dose chemotherapy in combination with antibodies or target agents would be included in this cohort.
Receives: Drug: High intensity therapies

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine in R/R AML patients the clinical benefit of low intensity therapy as shown by event-free survival compared to high intensity therapy.

    Event-free survival defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first.

    Measured: 36 months

Secondary outcomes (4)

  1. To determine if low intensity therapy improves overall survival

    Overall survival, defined as time from randomization to the date of death from any cause.

    Measured: 36 months

  2. To determine if low intensity therapy improves the overall response (Complete response (CR)/CR with partial hematologic recovery(CRh)/CR with incomplete hematologic recovery(CRi),morphologic leukemia-free state(MLFS))

    Overall response rate (CR/CRh/CRi, MLFS) as the best assessment of response during the study treatment and the overall study cohort.

    Measured: 36 months

  3. To determine if low intensity therapy improves patients-reported quality of life

    Change in Hematologic Malignancy-Patient-Reported Outcome (HM-PRO) A-total as defined by the HM-PRO questionnaire between screening and end of treatment assessment.

    Measured: 36 months

  4. To evaluate the safety of low intensity therapies as compared to high intensity therapies

    Proportion of patients experiencing adverse events.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2024
  2. Study start27 Feb 2025
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
339 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06713837
Sponsor's protocol ID
IRST204.07
Other IDs
2024-514517-35-00, 101104421
Acronym
IMPACT-AML
Status last verified
Aug 2026
First submitted
27 Nov 2024
Last updated
14 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing High intensity therapies and Low intensity therapies in people with Acute Myeloid Leukemia and Relapse/Recurrence, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 47 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Italy, Germany, Spain, Czechia, Lithuania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Oriana Nanni (+39 0543739100, cc.ubsc@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine in R/R AML patients the clinical benefit of low intensity therapy as shown by event-free survival compared to high intensity therapy. (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06713837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.

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IMPACT-AML Clinical Trial NCT06713837 | AzTrials