Master Framework For Relapse or Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients included in clinical trials may be enrolled except where otherwise specified in the experimental protocol.
Trial population
Patients with relapsed or refractory acute myeloid leukemia
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Registration into the STREAM platform
Other interventionAll 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.
Treatment groups
4,000 Participants
are divided into 1 treatment groupGroup A: Patients with relapsed or refractory acute myeloid leukemia1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8 yearsSecondary outcomes
1
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
Time frame
8 years2
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.
Time frame
8 years3
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.
Time frame
8 years4
Transplant rate
Proportion of patients undergoing transplantation
Time frame
8 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Lead sponsor
Hospital Vall d'Hebron
Collaborator
Cyprus Institute of Neurology and Genetics
Collaborator
European LeukemiaNet
Collaborator
Fundacion Para La Investigacion Hospital La Fe
Collaborator
Ostedusche Hematology and Oncology Study Group
Collaborator
Ospedale Pediatrico Bambin Gesù
Collaborator
Czech Lymphoma Study Group
Collaborator
Charite University, Berlin, Germany
Collaborator
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborator
University of Bologna
Collaborator
Hannover Medical School
Collaborator
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Collaborator
Toscana Life Sciences Sviluppo s.r.l.
Collaborator
Lithuanian University of Health Sciences
Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto
Collaborator
Time.Lex
Collaborator
Source ClinicalTrials.gov