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

August 13, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
      • Ancona, Italy, 60126
        • Not yet recruiting
        • Azienda Ospedaliero Universitaria delle Marche
        • Contact:
          • Lorenzo Brunetti, MD
      • 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
      • Naples, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
        • Contact:
          • Mario Annunziata, MD
      • Naples, Italy, 80131
        • Not yet recruiting
        • Azienda Ospeldaliera Universitaria Federico II
        • Contact:
          • Fabrizio Pane, MD
      • Novara, Italy, 28100
        • Recruiting
        • Aou Maggiore Della Carita
        • Contact:
          • Monia Lunghi, MD
      • Padova, Italy, 35100
        • Not yet recruiting
        • Azienda Ospedale-Università 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 Cà 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
        • Recruiting
        • AOU San Giovanni di Dio e Ruggi d'Aragona
        • Contact:
          • Bianca Serio, MD
    • TO
      • Torino, TO, Italy, 10126
        • Recruiting
        • AOU Città 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 Gdańsk
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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