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Acute Myeloid Leukemia, in RelapseIMPACT STREAMNCT06459024

Master Framework For Relapse or Refractory Acute Myeloid Leukemia

An observational study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 40 sites in 6 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 an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites Read more about this study

Who is it for?
Ages 6 years and older
What is being tested?
Registration into the STREAM platform
How many people
4,000 participants
Where
40 sitesin 6 countries
Study dates
28 Jun 2024to Jul 2032
Phase
Observational
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 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with relapsed or refractory acute myeloid leukemia

Who may be able to join

  • Patients with AML diagnosis according to WHO2022 or ICC2022
  • Treatment failure (i.e. relapse, refractory or progression, including MRD) according to ELN2022 criteria
  • Participant or his/her legal representative is willing and able to give informed consent for participation in the study

Who cannot join

  • Patients included in clinical trials may be enrolled except where otherwise specified in the experimental protocol.

Trial locations and contacts

40 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Oriana Nanni contact

+39 0543 739100

cc.ubsc@irst.emr.it

Impact-aml coord Impact-aml coord contact

impact-aml@irst.emr.it

40 sites in 6 countries

Italy32 sites, 32 recruiting

  • Azienda Ospedaliero Universitaria Delle Marche

    Ancona, 60126

    Lorenzo Brunetti, MD

    Not yet recruiting

  • Policlinico Sant'Orsola-Malpighi

    Bologna, BO, 40138

    Cristina Papayannidis, MD

    Recruiting

  • ASST Spedali Civili

    Brescia, BS, 25123

    Erika Borlenghi, MD

    Recruiting

  • Ospedale "A. Perrino"

    Brindisi, BR, 72100

    Marina Aurora Urbano, MD

    Recruiting

  • ASST Valle Olona

    Busto Arsizio, VA, 21052

    Elisabetta Todisco, MD

    Recruiting

  • IOV Istituto Oncologico Veneto

    Castelfranco Veneto, TV, 31033

    Alessandra Sperotto, MD

    Recruiting

  • Ospedale Valduce

    Como, CO, 22100

    Mauro Turrini, MD

    Recruiting

  • ASST Cremona

    Cremona, CR, 26100

    Alfredo Molteni, MD

    Recruiting

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, CN, 12100

    Daniele Mattei, MD

    Recruiting

  • AOU Universitaria Arcispedale Sant'Anna

    Ferrara, FE, 44124

    Gian Matteo Rigolin, MD

    Recruiting

  • AOU Careggi

    Florence, 50019

    Francesco Mannelli, MD

    Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova, GE, 16132

    Matteo Emidio Dragani, MD

    Recruiting

  • IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola, 47014

    Maria Benedetta Giannini, MD

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, MI, 20122

    Nicola Stefano Fracchiolla, MD

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162

    Rosa Greco, MD

    Recruiting

  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

    Naples, 80131

    Mario Annunziata, MD

    Recruiting

  • Azienda Ospeldaliera Universitaria Federico II

    Naples, 80131

    Fabrizio Pane, MD

    Not yet recruiting

  • AOU Maggiore della Carità

    Novara, 28100

    Monia Lunghi, MD

    Recruiting

  • Azienda Ospedale-Università Padova

    Padova, 35100

    Federica Lessi, MD

    Not yet recruiting

  • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

    Palermo, PA, 90146

    Antonino Mulè, MD

    Recruiting

  • Ospedale Santa Maria della Misericordia

    Perugia, PG, 06156

    Maria Paola Martelli, MD

    Recruiting

  • Presidio Ospedaliero "Santo Spirito"

    Pescara, PE, 65124

    Prassede Salutari, MD

    Not yet recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna, RA, 48121

    Giovanni Marconi, MD

    Recruiting

  • Ospedale infermi di Rimini

    Rimini, RN, 47923

    Anna Maria Mianulli, MD

    Recruiting

  • Fondazione Policlinico Tor Vergata

    Roma, RM, 00133

    Adriano Venditti, MD

    Recruiting

  • Policlinico Umberto I

    Roma, RM, 00161

    Saveria Capria, MD

    Recruiting

  • Policlinico Universitario Fondazione Agostino Gemelli

    Roma, RM, 00168

    Patrizia Chiusolo, MD

    Recruiting

  • Ospedale Sant'Andrea

    Roma, RM, 00189

    Agostino Tafuri, MD

    Recruiting

  • AOU San Giovanni di Dio e Ruggi d'Aragona

    Salerno, SA, 84131

    Bianca Serio, MD

    Recruiting

  • AOU Città della Salute e della Scienza di Torino

    Torino, TO, 10126

    Ernesta Audisio, MD

    Recruiting

  • AO Ordine Mauriziano

    Torino, TO, 10128

    Alessandro Cignetti, MD

    Recruiting

  • Ospedale San Bortolo

    Vicenza, 36100

    Davide Facchinelli, MD

    Recruiting

Other trials in Italy

Germany4 sites, 4 recruiting

  • University Hospital Aachen

    Aachen, 52074

    Martina Crysandt, MD

    Recruiting

  • University Hospital Greifswald

    Greifswald, 17475

    Adrian Schwarzer, MD

    Recruiting

  • University Hospital Halle

    Halle, 06120

    Judith Schaffrath, MD

    Recruiting

  • University Hospital of Rostock

    Rostock, 18507

    Christian Junghanß, MD

    Recruiting

Other trials in Germany

Lithuania1 site, 1 recruiting

  • The Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, 50161

    Rolandas Gerbutavičius, MD

    Recruiting

Other trials in Lithuania

Poland1 site, 1 recruiting

  • University Clinical Center in Gdańsk

    Gdansk, 80-214

    Karolina Bełdzińska-Gądek, MD

    Recruiting

Other trials in Poland

Romania1 site, 1 recruiting

  • Fundeni Clinical Institute

    Bucharest, 022328

    Daniel Coriu, MD

    Recruiting

Other trials in Romania

Spain1 site, 1 recruiting

  • University Hospital La Fe

    Valencia, 46026

    Pau Montesino, MD

    Recruiting

Other trials in Spain

About this study

Official title: Master Framework For Relapse or Refractory Acute Myeloid Leukemia- IMPACT STREAM - A Prospective Observational Study of Treatment Outcomes

This is an observational (non-interventional), prospective, cohort study that will collects data from patients diagnosed with relapsed or refractory acute myeloid leukemia afferent to the participanting clinical sites

Read the detailed description

Treatment outcome for acute myeloid leukemia (AML) has improved over the last few decades. With intensive multidrug induction regimens, a complete remission is expected. Despite such advances, therapy resistance or relapse remains the main causes of death in adult patients and in children. Relapsed or refractory (R/R) AML is a hard-to-treat disease, with a 5-year overall survival (OS) estimate below 20% in adults and 30%-35% in children, and no standard of care exists. HSCT (allogeneic hematopoietic stem cell transplantation) remains the only curative strategy for R/R AML patients, including pediatric and elderly ones. Some new personalized therapies have recently been integrated into the treatment options of R/R AML. However, there is a need to collect consistent data on the efficacy of these new strategies in real-world settings. Lack of data from clinical trials can be a barrier in most countries, limiting patient accessibility to some very effective drugs. The STREAM study is part of the Horizon Europe Mission Cancer 2022 IMPACT-AML project, that proposes to create an inclusive master framework for relapsed or refractory acute myeloid leukemia. In STREAM we will collect data and monitor outcomes of patients with R/R AML across Europe. In close collaboration with the European Reference Network on Rare Hematological Diseases (ERN-EuroBloodNet, GA101157011), STREAM is developed under ERN-EuroBloodNet central registry, the European Rare Blood Disorders Platform (ENROL), incorporating EU standards for interoperability and the GPDR-compliant SPIDER pseudonymization tool offered by the EU-RD Platform in the context of rare disease registries will be implemented, to allow cross-hospital and cross-country participation. The STREAM study will allow to collect high-quality data from patients at any stage of the disease, for any cancer subtype, in any age group, including pediatric and elderly population, unfit patients, patients with rare mutations, patients with high-impact end-organ damage, patients from rural regions, post-transplant relapse. Data collected in STREAM will foster the production of novel knowledge on rare populations in a pragmatic setting and will form the basis for building international trials to be conducted worldwide.

Being tested
Registration into the STREAM platform
Keywords
Relapsed, Refractory, Acute Myeloid Leukemia, Framework
Medical subject headings
Leukemia, Myeloid, Acute, Recurrence

What participants receive

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

  • Registration into the STREAM platformOther

    All patients fulfilling eligibility criteria will be registered into the STREAM platform. Baseline and follow up information will be recorded for each patient enrolled. Each patient will be followed up according to normal clinical practice up to 4 years.

Study groups in NCT06459024
Study groupRoleWhat they receive
Patients with relapsed or refractory acute myeloid leukemiaAll patients with relapsed or refractory acute myeloid leukemia
Receives: Other: Registration into the STREAM platform

What is being measured

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

  1. The primary endpoint is to determine the overall survival of R/R AML patients

    Overall survival is defined as the time from R/R diagnosis to death due to any cause.

    Measured: 8 years

Secondary outcomes (7)

  1. Remission rate

    Response is defined according to ELN 2022 criteria. Rates of CR, CRi, CRh and overall response (CR+CRi+CRh) as best response will be considered

    Measured: 8 years

  2. Event-free survival

    Event-free survival is defined as the time from R/R diagnosis to rescue treatment failure (according to ELN 2022 definitions), relapse or death due to any cause, whichever occurs first.

    Measured: 8 years

  3. Relapse free survival

    Relapse-free survival is defined for patients achieving a response to rescue treatment as the time from response onset to relapse or death due to any cause, whichever occurs first.

    Measured: 8 years

  4. Transplant rate

    Proportion of patients undergoing transplantation

    Measured: 8 years

  5. Describe the methods for diagnosis and the treatment options offered to the patients affected by R/R AML

    type and frequency of diagnostic procedures used and treatments prescribed

    Measured: 8 years

  6. Association between baseline clinical, molecular and biological parameters and clinical outcomes

    Rates of CR, CRi, CRh and overall response (CR+CRi+CRh) in specific sub-populations bearing common molecular features

    Measured: 8 years

  7. To characterize potential populations that could be target for future studies/clinical trials

    descriptive statistics (mean, median, frequency, range) of subpopulations characteristics

    Measured: 8 years

Timeline

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

  1. First posted14 Jun 2024
  2. Study start28 Jun 2024
  3. Primary completionJul 2032 (estimated)
  4. Study completionJul 2032 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06459024
Sponsor's protocol ID
IRST204.08
Acronym
IMPACT STREAM
Status last verified
Aug 2026
First submitted
10 Jun 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?

An observational study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 40 sites in 6 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 3 inclusion and 1 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 40 sites in Italy, Germany, Lithuania, Poland, Romania and 1 more country. 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.

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 0543 739100, 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?

The primary endpoint is to determine the overall survival of R/R AML patients (time frame: 8 years). 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 NCT06459024.

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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