NCT06459024

Master Framework For Relapse or Refractory Acute Myeloid Leukemia

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-28
• Primary completion: 2032-07-01
• Completion: 2032-07-01
• First posted: 2024-06-14
• Last updated: 2026-03-10

Locations

38 sites across 6 countries: Germany, Italy, Lithuania, Poland, Romania, Spain