Clinical trial NCT06459024: Master Framework For Relapse or Refractory Acute Myeloid Leukemia
Official title: Master Framework For Relapse or Refractory Acute Myeloid Leukemia- IMPACT STREAM - A Prospective Observational Study of Treatment Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia Refractory
Keywords: Relapsed
Refractory
Acute Myeloid Leukemia
Framework
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
name: Cyprus Institute of Neurology and Genetics
name: European LeukemiaNet
name: Fundacion Para La Investigacion Hospital La Fe
name: Ostedusche Hematology and Oncology Study Group
name: Ospedale Pediatrico Bambin Gesù
name: Czech Lymphoma Study Group
name: Charite University, Berlin, Germany
name: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
name: University of Bologna
name: Hannover Medical School
name: German Society for Pediatric Oncology and Hematology GPOH gGmbH
name: Toscana Life Sciences Sviluppo s.r.l.
name: Lithuanian University of Health Sciences
name: Gruppo Italiano Malattie EMatologiche dell'Adulto
name: Time.Lex
First posted: 2024-06-14
Enrollment: 4000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with relapsed or refractory acute myeloid leukemia

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint is to determine the overall survival of R/R AML patients
timeFrame: 8 years
Secondary outcomes:
measure: Remission rate
timeFrame: 8 years
measure: Event-free survival
timeFrame: 8 years
measure: Relapse free survival
timeFrame: 8 years
measure: Transplant rate
timeFrame: 8 years
measure: Describe the methods for diagnosis and the treatment options offered to the patients affected by R/R AML
timeFrame: 8 years
measure: Association between baseline clinical, molecular and biological parameters and clinical outcomes
timeFrame: 8 years
measure: To characterize potential populations that could be target for future studies/clinical trials
timeFrame: 8 years
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Hospital Greifswald
city: Halle
country: Germany
facility: University Hospital Halle
city: Rostock
country: Germany
facility: University Hospital of Rostock
city: Bologna
country: Italy
facility: Policlinico Sant'Orsola-Malpighi
state: BO
city: Brindisi
country: Italy
facility: Ospedale "A. Perrino"
state: BR
city: Brescia
country: Italy
facility: ASST Spedali Civili
state: BS
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S. Croce e Carle
state: CN
city: Como
country: Italy
facility: Ospedale Valduce
state: CO
city: Cremona
country: Italy
facility: ASST Cremona
state: CR
city: Ferrara
country: Italy
facility: AOU Universitaria Arcispedale Sant'Anna
state: FE
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
state: GE
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: MI
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: MI
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
state: PA
city: Pescara
country: Italy
facility: Presidio Ospedaliero "Santo Spirito"
state: PE
city: Perugia
country: Italy
facility: Ospedale Santa Maria della Misericordia
state: PG
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
state: RA
city: Roma
country: Italy
facility: Fondazione Policlinico Tor Vergata
state: RM
city: Roma
country: Italy
facility: Policlinico Umberto I
state: RM
city: Roma
country: Italy
facility: Policlinico Universitario Fondazione Agostino Gemelli
state: RM
city: Roma
country: Italy
facility: Ospedale Sant'Andrea
state: RM
city: Rimini
country: Italy
facility: Ospedale infermi di Rimini
state: RN
city: Salerno
country: Italy
facility: AOU San Giovanni di Dio e Ruggi d'Aragona
state: SA
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
state: TO
city: Torino
country: Italy
facility: AO Ordine Mauriziano
state: TO
city: Castelfranco Veneto
country: Italy
facility: IOV Istituto Oncologico Veneto
state: TV
city: Busto Arsizio
country: Italy
facility: ASST Valle Olona
state: VA
city: Meldola
country: Italy
facility: IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
city: Novara
country: Italy
facility: AOU Maggiore della Carità
city: Valencia
country: Spain
facility: University Hospital La Fe
Study officials:
affiliation: University of Bologna
name: Giovanni Martinelli, MD, Prof
role: STUDY_CHAIR
References: