Master Framework For Relapse or Refractory Acute Myeloid Leukemia (IMPACT STREAM)

March 9, 2026 updated by: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • University Hospital Aachen
        • Contact:
          • Martina Crysandt, MD
      • Greifswald, Germany, 17475
        • Recruiting
        • University Hospital Greifswald
        • Contact:
          • Adrian Schwarzer, MD
      • Halle, Germany, 06120
        • Recruiting
        • University Hospital Halle
        • Contact:
          • Judith Schaffrath, MD
      • Rostock, Germany, 18507
        • Recruiting
        • University Hospital of Rostock
        • Contact:
          • Christian Junghanß, MD
  • Italy
      • Florence, Italy, 50019
        • Recruiting
        • AOU Careggi
        • Contact:
          • Francesco Mannelli, MD
      • Meldola, Italy, 47014
        • Recruiting
        • IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
        • Contact:
          • Maria Benedetta Giannini, MD
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
        • Contact:
          • Mario Annunziata, MD
      • Novara, Italy, 28100
        • Recruiting
        • Aou Maggiore Della Carita
        • Contact:
          • Monia Lunghi, MD
      • Padua, Italy, 35100
        • Not yet recruiting
        • Azienda Ospedale-Universita Padova
        • Contact:
          • Federica Lessi, MD
      • Vicenza, Italy, 36100
        • Recruiting
        • Ospedale san Bortolo
        • Contact:
          • Davide Facchinelli, MD
    • BO
      • Bologna, BO, Italy, 40138
        • Recruiting
        • Policlinico Sant'Orsola-Malpighi
        • Contact:
          • Cristina Papayannidis, MD
    • BR
      • Brindisi, BR, Italy, 72100
        • Recruiting
        • Ospedale "A. Perrino"
        • Contact:
          • Marina Aurora Urbano, MD
    • BS
      • Brescia, BS, Italy, 25123
        • Recruiting
        • ASST Spedali Civili
        • Contact:
          • Erika Borlenghi, MD
    • CN
      • Cuneo, CN, Italy, 12100
        • Recruiting
        • Azienda Ospedaliera S. Croce e Carle
        • Contact:
          • Daniele Mattei, MD
    • CO
      • Como, CO, Italy, 22100
        • Recruiting
        • Ospedale Valduce
        • Contact:
          • Mauro Turrini, MD
    • CR
      • Cremona, CR, Italy, 26100
        • Recruiting
        • ASST Cremona
        • Contact:
          • Alfredo Molteni, MD
    • FE
      • Ferrara, FE, Italy, 44124
        • Recruiting
        • AOU Universitaria Arcispedale Sant'Anna
        • Contact:
          • Gian Matteo Rigolin, MD
    • GE
      • Genova, GE, Italy, 16132
        • Recruiting
        • IRCCS Ospedale Policlinico San Martino
        • Contact:
          • Matteo Emidio Dragani, MD
    • MI
      • Milan, MI, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
        • Contact:
          • Nicola Stefano Fracchiolla, MD
      • Milan, MI, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
        • Contact:
          • Rosa Greco, MD
    • PA
      • Palermo, PA, Italy, 90146
        • Recruiting
        • Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
        • Contact:
          • Antonino Mulè, MD
    • PE
      • Pescara, PE, Italy, 65124
        • Not yet recruiting
        • Presidio Ospedaliero "Santo Spirito"
        • Contact:
          • Prassede Salutari, MD
    • PG
      • Perugia, PG, Italy, 06156
        • Recruiting
        • Ospedale Santa Maria Della Misericordia
        • Contact:
          • Maria Paola Martelli, MD
    • RA
      • Ravenna, RA, Italy, 48121
        • Recruiting
        • Ospedale Santa Maria delle Croci
        • Contact:
          • Giovanni Marconi, MD
    • RM
      • Roma, RM, Italy, 00161
        • Recruiting
        • Policlinico Umberto I
        • Contact:
          • Saveria Capria, MD
      • Roma, RM, Italy, 00189
        • Recruiting
        • Ospedale Sant'Andrea
        • Contact:
          • Agostino Tafuri, MD
      • Roma, RM, Italy, 00168
        • Recruiting
        • Policlinico Universitario Fondazione Agostino Gemelli
        • Contact:
          • Patrizia Chiusolo, MD
      • Roma, RM, Italy, 00133
        • Recruiting
        • Fondazione Policlinico Tor Vergata
        • Contact:
          • Adriano Venditti, MD
    • RN
      • Rimini, RN, Italy, 47923
        • Recruiting
        • Ospedale Infermi di Rimini
        • Contact:
          • Anna Maria Mianulli, MD
    • SA
      • Salerno, SA, Italy, 84131
        • Not yet recruiting
        • AOU San Giovanni di Dio e Ruggi d'Aragona
        • Contact:
          • Bianca Serio, MD
    • TO
      • Torino, TO, Italy, 10126
        • Recruiting
        • AOU Citta della Salute e della Scienza di Torino
        • Contact:
          • Ernesta Audisio, MD
      • Torino, TO, Italy, 10128
        • Recruiting
        • AO Ordine Mauriziano
        • Contact:
          • Alessandro Cignetti, MD
    • TV
      • Castelfranco Veneto, TV, Italy, 31033
        • Recruiting
        • IOV Istituto Oncologico Veneto
        • Contact:
          • Alessandra Sperotto, MD
    • VA
      • Busto Arsizio, VA, Italy, 21052
        • Recruiting
        • ASST Valle Olona
        • Contact:
          • Elisabetta Todisco, MD
  • Lithuania
      • Kaunas, Lithuania, 50161
        • Recruiting
        • The Hospital of Lithuanian University of Health Sciences Kauno Klinikos
        • Contact:
          • Rolandas Gerbutavičius, MD
  • Poland
      • Gdansk, Poland, 80-214
        • Recruiting
        • University Clinical Center in Gdansk
        • Contact:
          • Karolina Bełdzińska-Gądek, MD
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute
        • Contact:
          • Daniel Coriu, MD
  • Spain
      • Valencia, Spain, 46026
        • Recruiting
        • University Hospital La Fe
        • Contact:
          • Pau Montesino, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with relapsed or refractory acute myeloid leukemia

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with relapsed or refractory acute myeloid leukemia
All patients with relapsed or refractory acute myeloid leukemia
Other: Registration into the STREAM platform
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is to determine the overall survival of R/R AML patients
Time Frame: 8 years
Overall survival is defined as the time from R/R diagnosis to death due to any cause.
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission rate
Time Frame: 8 years
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
8 years
Event-free survival
Time Frame: 8 years
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.
8 years
Relapse free survival
Time Frame: 8 years
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.
8 years
Transplant rate
Time Frame: 8 years
Proportion of patients undergoing transplantation
8 years
Describe the methods for diagnosis and the treatment options offered to the patients affected by R/R AML
Time Frame: 8 years
type and frequency of diagnostic procedures used and treatments prescribed
8 years
Association between baseline clinical, molecular and biological parameters and clinical outcomes
Time Frame: 8 years
Rates of CR, CRi, CRh and overall response (CR+CRi+CRh) in specific sub-populations bearing common molecular features
8 years
To characterize potential populations that could be target for future studies/clinical trials
Time Frame: 8 years
descriptive statistics (mean, median, frequency, range) of subpopulations characteristics
8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Charite University, Berlin, Germany
University of Bologna
Hannover Medical School
Lithuanian University of Health Sciences
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Gruppo Italiano Malattie EMatologiche dell'Adulto
Hospital Vall d'Hebron
Fundacion Para La Investigacion Hospital La Fe
Toscana Life Sciences Sviluppo s.r.l.
Cyprus Institute of Neurology and Genetics
Czech Lymphoma Study Group
European LeukemiaNet
Ospedale Pediatrico Bambin Gesù
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Ostedusche Hematology and Oncology Study Group
Time.Lex

Investigators

  • Study Chair: Giovanni Martinelli, MD, Prof, University of Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2024

Primary Completion (Estimated)

July 1, 2032

Study Completion (Estimated)

July 1, 2032

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRST204.08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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