Italian Non-Interventional Study of FLT3 Mutated AML Patients
FLAM
1 other identifier
observational
800
1 country
33
Brief Summary
This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3+ mutations
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Typical duration for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2018
CompletedFirst Posted
Study publicly available on registry
June 6, 2018
CompletedStudy Start
First participant enrolled
July 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedApril 21, 2020
April 1, 2020
2.8 years
May 11, 2018
April 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
percentage of patients FLT3 negative at diagnosis who relapse FLT3 positive;
description of how the FLT3 mutational status changes during the course and management of the disease
up to 24 months
percentage of patients FLT3 positive at diagnosis who relapse FLT3 negative
description of how the FLT3 mutational status changes during the course and management of the disease
up to 24 months
Secondary Outcomes (10)
objective overall response rate (ORR)
up to 24 months
disease-free survival (DFS)
up to 24 months
overall survival (OS)
up to 24 months
Percentage of AML patients with specific types of FLT3 mutations
up to 24 months
distribution of specific FLT3 mutations in AML patients
up to 24 months
- +5 more secondary outcomes
Study Arms (1)
AML patients
Clinical and Molecular data collection of AML Patients with FLT3 mutations (ITD or TKD)
Interventions
Clinical and Molecular data collection at diagnosis, during treatment and at each relapse
Eligibility Criteria
All consecutive patient with FLT3 mutated AML documented at diagnosis or at the time of relapse/refractory state treated in the participating center. With regards to the retrospective collection, data from the eligible and acconsenting patients will be retrieved since 2012, that is, when the evaluation of FLT3 mutation was almost routine in the centers considered in the study.
You may qualify if:
- AML patients
- Male or Female
- Aged ≥ 18 years
- FLT3 mutations (ITD or TKD) positive tests performed at diagnosis or at relapse.
- Participant is willing and able to give informed consent for participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
AOU Ospedali riuniti di Ancona
Ancona, AN, 60126, Italy
AOU Policlinico Bari - Ematologia
Bari, BA, 70124, Italy
Università di Bologna - DIMES
Bologna, BO, 40138, Italy
ASST Spedali di Brescia
Brescia, BS, 25123, Italy
Azienda Ospedaliera G. Brotzu
Cagliari, CA, 09121, Italy
Azienda Ospedaliera S. Croce e Carle
Cuneo, CN, 12100, Italy
Ematologia - Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro
Catanzaro, CZ, 88100, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, 47014, Italy
AOU Universitaria Arcispedale Sant'Anna
Cona, Ferrara, 44124, Italy
IRCCS Casa sollievo della sofferenza
San Giovanni Rotondo, FG, 71013, Italy
AOU Careggi
Florence, FI, 50134, Italy
Ospedale Vito Fazzi di Lecce
Lecce, LE, 73100, Italy
AOU Policlinico Gaetano Martino
Messina, ME, 98125, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, MI, 20122, Italy
Ospedale San Raffaele
Milan, MI, 20132, Italy
Istituto Europeo di Oncologia
Milan, MI, 20141, Italy
Ospedali Riuniti Villa Sofia-Cervello
Palermo, PA, 90146, Italy
Ospedale "Guglielmo da Saliceto"
Piacenza, PC, 29121, Italy
Irccs Crob
Rionero in Vulture, Potenza, 85028, Italy
Azienda Ospedaliero-Universitaria di Parma - Ematologia e CTMO
Parma, PR, 43125, Italy
UO Ematologia, Ospedale S.Maria delle Croci
Ravenna, RA, 48121, Italy
Grande Ospedale Metropolitano
Reggio Calabria, RC, 89123, Italy
Ospedale infermi di Rimini
Rimini, RN, 47923, Italy
AOU San Giovannidi Dio e Ruggi - ematologia
Salerno, SA, 84131, Italy
AOC di Ematologia - AOU Senese
Siena, SI, 53100, Italy
Università di Torino - Ospedale San Luigi Gonzaga
Orbassano, TO, 10043, Italy
AOU Città della Salute e della Scienza di Torino
Torino, TO, 10126, Italy
A.O. Ordine Mauriziano Torino
Torino, TO, 10128, Italy
Divisione di Ematologia - Università di Udine
Udine, UD, 33100, Italy
AO Universitaria Federico II
Napoli, 80131, Italy
AOU Maggiore della carità
Novara, 28100, Italy
AOU Santa Maria della Misericordia - Ematologia
Perugia, 06129, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Study Officials
- STUDY CHAIR
Giovanni Martinelli, MD
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2018
First Posted
June 6, 2018
Study Start
July 18, 2018
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
April 21, 2020
Record last verified: 2020-04