Master Framework For Relapse or Refractory Acute Myeloid Leukemia

Acute Myeloid Leukemia, in Relapse Clinical Trial

— IMPACT STREAM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06459024
• Other study ID #: IRST204.08
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: July 2032

Study information

• Verified date: June 2024
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Oriana Nanni
• Phone: +39 0543 739100
• Email: cc.ubsc[@]irst.emr.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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 STREAM, 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 endorgan 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4000
• Est. completion date: July 2032
• Est. primary completion date: July 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia Refractory
• Acute Myeloid Leukemia, in Relapse
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
Italy	ASST Spedali Civili	Brescia	BS
Italy	Ospedale Valduce	Como	CO
Italy	ASST Cremona	Cremona	CR
Italy	Azienda Ospedaliera S. Croce e Carle	Cuneo	CN
Italy	AOU Universitaria Arcispedale Sant'Anna	Ferrara	FE
Italy	IRCCS Ospedale Policlinico San Martino	Genova	GE
Italy	IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori	Meldola
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano	MI
Italy	AOU Maggiore della Carità	Novara
Italy	Ospedale Santa Maria della Misericordia	Perugia	PG
Italy	Ospedale Santa Maria delle Croci	Ravenna	RA
Italy	Ospedale infermi di Rimini	Rimini	RN
Italy	Policlinico Umberto I	Roma	RM
Italy	AOU San Giovanni di Dio e Ruggi d'Aragona	Salerno	SA
Italy	AOU Città della Salute e della Scienza di Torino	Torino	TO

Sponsors (17)

Lead Sponsor

Collaborator

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 years
Secondary	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	8 years
Secondary	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.	8 years
Secondary	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.	8 years
Secondary	Transplant rate	Proportion of patients undergoing transplantation	8 years
Secondary	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	8 years
Secondary	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	8 years
Secondary	To characterize potential populations that could be target for future studies/clinical trials	descriptive statistics (mean, median, frequency, range) of subpopulations characteristics	8 years