Master Framework For Relapse or Refractory Acute Myeloid Leukemia
IMPACT STREAM
1 other identifier
observational
4,000
6 countries
38
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Longer than P75 for all trials
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2024
CompletedFirst Posted
Study publicly available on registry
June 14, 2024
CompletedStudy Start
First participant enrolled
June 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2032
March 10, 2026
March 1, 2026
8 years
June 10, 2024
March 9, 2026
Conditions
Keywords
Outcome Measures
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.
8 years
Secondary Outcomes (7)
Remission rate
8 years
Event-free survival
8 years
Relapse free survival
8 years
Transplant rate
8 years
Describe the methods for diagnosis and the treatment options offered to the patients affected by R/R AML
8 years
- +2 more secondary outcomes
Study Arms (1)
Patients with relapsed or refractory acute myeloid leukemia
All patients with relapsed or refractory acute myeloid leukemia
Interventions
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.
Eligibility Criteria
Patients with relapsed or refractory acute myeloid leukemia
You may qualify if:
- 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
You may not qualify if:
- Patients included in clinical trials may be enrolled except where otherwise specified in the experimental protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Vall d'Hebroncollaborator
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSlead
- Cyprus Institute of Neurology and Geneticscollaborator
- European LeukemiaNetcollaborator
- Fundacion Para La Investigacion Hospital La Fecollaborator
- Ostedusche Hematology and Oncology Study Groupcollaborator
- Ospedale Pediatrico Bambin Gesùcollaborator
- Czech Lymphoma Study Groupcollaborator
- Charite University, Berlin, Germanycollaborator
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y Leóncollaborator
- University of Bolognacollaborator
- Hannover Medical Schoolcollaborator
- German Society for Pediatric Oncology and Hematology GPOH gGmbHcollaborator
- Toscana Life Sciences Sviluppo s.r.l.collaborator
- Lithuanian University of Health Sciencescollaborator
- Gruppo Italiano Malattie EMatologiche dell'Adultocollaborator
- Time.Lexcollaborator
Study Sites (38)
University Hospital Aachen
Aachen, 52074, Germany
University Hospital Greifswald
Greifswald, 17475, Germany
University Hospital Halle
Halle, 06120, Germany
University Hospital of Rostock
Rostock, 18507, Germany
Policlinico Sant'Orsola-Malpighi
Bologna, BO, 40138, Italy
Ospedale "A. Perrino"
Brindisi, BR, 72100, Italy
ASST Spedali Civili
Brescia, BS, 25123, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, CN, 12100, Italy
Ospedale Valduce
Como, CO, 22100, Italy
ASST Cremona
Cremona, CR, 26100, Italy
AOU Universitaria Arcispedale Sant'Anna
Ferrara, FE, 44124, Italy
IRCCS Ospedale Policlinico San Martino
Genova, GE, 16132, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, MI, 20122, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, 20162, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
Palermo, PA, 90146, Italy
Presidio Ospedaliero "Santo Spirito"
Pescara, PE, 65124, Italy
Ospedale Santa Maria della Misericordia
Perugia, PG, 06156, Italy
Ospedale Santa Maria delle Croci
Ravenna, RA, 48121, Italy
Fondazione Policlinico Tor Vergata
Roma, RM, 00133, Italy
Policlinico Umberto I
Roma, RM, 00161, Italy
Policlinico Universitario Fondazione Agostino Gemelli
Roma, RM, 00168, Italy
Ospedale Sant'Andrea
Roma, RM, 00189, Italy
Ospedale infermi di Rimini
Rimini, RN, 47923, Italy
AOU San Giovanni di Dio e Ruggi d'Aragona
Salerno, SA, 84131, Italy
AOU Città della Salute e della Scienza di Torino
Torino, TO, 10126, Italy
AO Ordine Mauriziano
Torino, TO, 10128, Italy
IOV Istituto Oncologico Veneto
Castelfranco Veneto, TV, 31033, Italy
ASST Valle Olona
Busto Arsizio, VA, 21052, Italy
AOU Careggi
Florence, 50019, Italy
IRST Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola, 47014, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Naples, 80131, Italy
AOU Maggiore della Carità
Novara, 28100, Italy
Azienda Ospedale-Università Padova
Padua, 35100, Italy
Ospedale San Bortolo
Vicenza, 36100, Italy
The Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, 50161, Lithuania
University Clinical Center in Gdańsk
Gdansk, 80-214, Poland
Fundeni Clinical Institute
Bucharest, 022328, Romania
University Hospital La Fe
Valencia, 46026, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Giovanni Martinelli, MD, Prof
University of Bologna
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2024
First Posted
June 14, 2024
Study Start
June 28, 2024
Primary Completion (Estimated)
July 1, 2032
Study Completion (Estimated)
July 1, 2032
Last Updated
March 10, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share