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Master Framework For Relapse or Refractory Acute Myeloid Leukemia

NCT ID: NCT06459024

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-28

Study Completion Date

2032-07-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory

Keywords

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Relapsed Refractory Acute Myeloid Leukemia Framework

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with relapsed or refractory acute myeloid leukemia

All patients with relapsed or refractory acute myeloid leukemia

Registration into the STREAM platform

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Vall d'Hebron

OTHER

Sponsor Role collaborator

Cyprus Institute of Neurology and Genetics

OTHER

Sponsor Role collaborator

European LeukemiaNet

NETWORK

Sponsor Role collaborator

Fundacion Para La Investigacion Hospital La Fe

OTHER

Sponsor Role collaborator

Ostedusche Hematology and Oncology Study Group

UNKNOWN

Sponsor Role collaborator

Ospedale Pediatrico Bambin Gesù

OTHER

Sponsor Role collaborator

Czech Lymphoma Study Group

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

OTHER

Sponsor Role collaborator

University of Bologna

OTHER

Sponsor Role collaborator

Hannover Medical School

OTHER

Sponsor Role collaborator

German Society for Pediatric Oncology and Hematology GPOH gGmbH

OTHER

Sponsor Role collaborator

Toscana Life Sciences Sviluppo s.r.l.

INDUSTRY

Sponsor Role collaborator

Lithuanian University of Health Sciences

OTHER

Sponsor Role collaborator

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

Sponsor Role collaborator

Time.Lex

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Martinelli, MD, Prof

Role: STUDY_CHAIR

University of Bologna

Locations

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University Hospital Aachen

Aachen, , Germany

Site Status NOT_YET_RECRUITING

University Hospital Greifswald

Greifswald, , Germany

Site Status RECRUITING

University Hospital Halle

Halle, , Germany

Site Status RECRUITING

University Hospital of Rostock

Rostock, , Germany

Site Status RECRUITING

Policlinico Sant'Orsola-Malpighi

Bologna, BO, Italy

Site Status RECRUITING

Ospedale "A. Perrino"

Brindisi, BR, Italy

Site Status RECRUITING

ASST Spedali Civili

Brescia, BS, Italy

Site Status RECRUITING

Azienda Ospedaliera S. Croce e Carle

Cuneo, CN, Italy

Site Status RECRUITING

Ospedale Valduce

Como, CO, Italy

Site Status RECRUITING

ASST Cremona

Cremona, CR, Italy

Site Status RECRUITING

AOU Universitaria Arcispedale Sant'Anna

Ferrara, FE, Italy

Site Status RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, GE, Italy

Site Status RECRUITING

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, MI, Italy

Site Status RECRUITING

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy

Site Status RECRUITING

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, PA, Italy

Site Status RECRUITING

Presidio Ospedaliero "Santo Spirito"

Pescara, PE, Italy

Site Status NOT_YET_RECRUITING

Ospedale Santa Maria della Misericordia

Perugia, PG, Italy

Site Status RECRUITING

Ospedale Santa Maria delle Croci

Ravenna, RA, Italy

Site Status RECRUITING

Fondazione Policlinico Tor Vergata

Roma, RM, Italy

Site Status NOT_YET_RECRUITING

Policlinico Umberto I

Roma, RM, Italy

Site Status RECRUITING

Policlinico Universitario Fondazione Agostino Gemelli

Roma, RM, Italy

Site Status RECRUITING

Ospedale Sant'Andrea

Roma, RM, Italy

Site Status RECRUITING

Ospedale infermi di Rimini

Rimini, RN, Italy

Site Status RECRUITING

AOU San Giovanni di Dio e Ruggi d'Aragona

Salerno, SA, Italy

Site Status NOT_YET_RECRUITING

AOU Città della Salute e della Scienza di Torino

Torino, TO, Italy

Site Status RECRUITING

AO Ordine Mauriziano

Torino, TO, Italy

Site Status RECRUITING

IOV Istituto Oncologico Veneto

Castelfranco Veneto, TV, Italy

Site Status RECRUITING

ASST Valle Olona

Busto Arsizio, VA, Italy

Site Status RECRUITING

IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola, , Italy

Site Status RECRUITING

AOU Maggiore della Carità

Novara, , Italy

Site Status RECRUITING

The Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, , Lithuania

Site Status RECRUITING

University Clinical Center in Gdańsk

Gdansk, , Poland

Site Status RECRUITING

Fundeni Clinical Institute

Bucharest, , Romania

Site Status RECRUITING

University Hospital La Fe

Valencia, , Spain

Site Status RECRUITING

Countries

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Germany Italy Lithuania Poland Romania Spain

Central Contacts

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Oriana Nanni

Role: CONTACT

Phone: +39 0543 739100

Email: [email protected]

Impact-aml coord Impact-aml coord

Role: CONTACT

Email: [email protected]

Facility Contacts

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Martina Crysandt, MD

Role: primary

Adrian Schwarzer, MD

Role: primary

Judith Schaffrath, MD

Role: primary

Christian Junghanß, MD

Role: primary

Cristina Papayannidis, MD

Role: primary

Marina Aurora Urbano, MD

Role: primary

Erika Borlenghi, MD

Role: primary

Daniele Mattei, MD

Role: primary

Mauro Turrini, MD

Role: primary

Alfredo Molteni, MD

Role: primary

Gian Matteo Rigolin, MD

Role: primary

Matteo Emidio Dragani, MD

Role: primary

Nicola Stefano Fracchiolla, MD

Role: primary

Rosa Greco, MD

Role: primary

Antonino Mulè, MD

Role: primary

Prassede Salutari, MD

Role: primary

Maria Paola Martelli, MD

Role: primary

Giovanni Marconi, MD

Role: primary

Adriano Venditti, MD

Role: primary

Saveria Capria, MD

Role: primary

Patrizia Chiusolo, MD

Role: primary

Agostino Tafuri, MD

Role: primary

Anna Maria Mianulli, MD

Role: primary

Bianca Serio, MD

Role: primary

Ernesta Audisio, MD

Role: primary

Alessandro Cignetti, MD

Role: primary

Alessandra Sperotto, MD

Role: primary

Elisabetta Todisco, MD

Role: primary

Maria Benedetta Giannini, MD

Role: primary

Monia Lunghi, MD

Role: primary

Rolandas Gerbutavičius, MD

Role: primary

Karolina Bełdzińska-Gądek, MD

Role: primary

Daniel Coriu, MD

Role: primary

Pau Montesino, MD

Role: primary

Other Identifiers

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IRST204.08

Identifier Type: -

Identifier Source: org_study_id