Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459024
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-10
Brief Title:
Master Framework For Relapse or Refractory Acute Myeloid Leukemia
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Organization:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Overview
Official Title:
Master Framework For Relapse or Refractory Acute Myeloid Leukemia- IMPACT STREAM - A Prospective Observational Study of Treatment Outcomes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPACT STREAM
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 RR 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 RR AML patients including pediatric and elderly ones Some new personalized therapies have recently been integrated into the treatment options of RR 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 RR 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None