Italian Non-Interventional Study of FLT3 Mutated AML Patients
- Conditions
- AMLFLT3-TKD MutationFLT3-ITD Mutation
- Interventions
- Genetic: Clinical and Molecular data collection
- Registration Number
- NCT03547258
- 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
- Detailed Description
This is an observational study involving a retrospective and prospective collection of clinical and molecular data. Patients will follow their regular diagnostic and clinical practice. Thus, no additional procedure/blood withdrawal will be performed.
The study will be conducted as follows:
1. Retrospective phase: clinical and molecular data of AML patients with FLT3+ mutations detected at diagnosis or at any refractory/relapse state will be collected.
2. Prospective phase: clinical and molecular data of each new FLT3+ AML patient identified in participating centers at diagnosis or at any refractory/relapse state will be collected prospectively. Every effort will be done to include all consecutive patients, in order to avoid selection bias.
For patients with a mutation found at the time of disease relapse, any effort will be done to collect all the clinical and molecular information since the time of diagnosis.
The Primary objective of this study is to analyze how FLT3 mutational status evolve during the management of the disease looking at the percentage of patients with no FLT3 mutations at diagnosis who relapse with a new FLT3 mutation detected, and the percentage of FLT3 positive AML patients that after having obtained a Complete Remission relapse with FLT3 negative.
The secondary objective of the study is to investigate the association between different FLT3 mutations and the clinical, molecular and biological information.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description AML patients Clinical and Molecular data collection Clinical and Molecular data collection of AML Patients with FLT3 mutations (ITD or TKD)
- Primary Outcome Measures
Name Time Method percentage of patients FLT3 negative at diagnosis who relapse FLT3 positive; up to 24 months description of how the FLT3 mutational status changes during the course and management of the disease
percentage of patients FLT3 positive at diagnosis who relapse FLT3 negative up to 24 months description of how the FLT3 mutational status changes during the course and management of the disease
- Secondary Outcome Measures
Name Time Method objective overall response rate (ORR) up to 24 months the objective overall response rate (ORR) defined as the proportion of patients with a partial or response (CR, CRi, CRp) response, to initial treatment and in case of salvage;
disease-free survival (DFS) up to 24 months disease-free survival (DFS) after first CR and after CR2/CR3, if applicable, defined as the time since CR (or CR2 or CR3) to disease relapse or death for any cause, whichever occurs first.
Percentage of AML patients with specific types of FLT3 mutations up to 24 months Percentage of AML patients with specific types of FLT3 mutations, at initial diagnosis and at disease relapse
retrospective collection of surrogate measures of QoL up to 24 months the surrogate measures of QoL , as the number and days of hospitalizations per patient, number of clinical visits per patient, number of access in Day Hospital and Emergency Care Units per patient, and the use of antalgic drugs and neuro-active drugs, will be expressed in terms of mean values per patient or through proportions
overall survival (OS) up to 24 months overall survival (OS) defined as the time since date of diagnosis until death for any cause or the last available patient contact.
distribution of specific FLT3 mutations in AML patients up to 24 months distribution of specific FLT3 mutations in AML patients according to: age, WBC, LDH, cytogenetics, NPM1, CEBPA alterations, IDH1/2, tp53, DNMT3A, secondary vs de novo AML;
frequency of the different methods used to evaluate (Minimal residual disease) MRD up to 24 months the frequency of the different methods used to evaluate MRD such as, wt1 ratio or the fusion transcript level by Reverse transcription polymerase chain reaction (RT-PCR); percentage of patients performing FLT3 ITD analysis by Next Generation Sequencing (NGS);
transplantation percentage up to 24 months percentage of FLT3 mutated AML patients undergoing transplantation
evaluation of modifications in terms of quality of life (QoL) of patients with FLT3 mutated AML up to 24 months scores for each patient and each scale as well as a summary QoL score will be computed according to the EORTC QLQ-C3 (quality of life questionnaire) manual
FLT3-ITD allelic ratio up to 24 months FLT3-ITD allelic ratio defined as the ratio of the area under the curve of mutant and wild type alleles (mutant/totalFLT3) obtained after Fragment analysis for FLT3-ITD;
Trial Locations
- Locations (33)
AOU Ospedali riuniti di Ancona
🇮🇹Ancona, AN, Italy
AOU Policlinico Bari - Ematologia
🇮🇹Bari, BA, Italy
Università di Bologna - DIMES
🇮🇹Bologna, BO, Italy
Azienda Ospedaliera S. Croce e Carle
🇮🇹Cuneo, CN, Italy
ASST Spedali di Brescia
🇮🇹Brescia, BS, Italy
Azienda Ospedaliera G. Brotzu
🇮🇹Cagliari, CA, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
🇮🇹Meldola, FC, Italy
IRCCS Casa sollievo della sofferenza
🇮🇹San Giovanni Rotondo, FG, Italy
Ematologia - Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro
🇮🇹Catanzaro, CZ, Italy
AOU Careggi
🇮🇹Firenze, FI, Italy
Ospedale Vito Fazzi di Lecce
🇮🇹Lecce, LE, Italy
Ospedale San Raffaele
🇮🇹Milano, MI, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, MI, Italy
Ospedali Riuniti Villa Sofia-Cervello
🇮🇹Palermo, PA, Italy
Ospedale "Guglielmo da Saliceto"
🇮🇹Piacenza, PC, Italy
UO Ematologia, Ospedale S.Maria delle Croci
🇮🇹Ravenna, RA, Italy
Azienda Ospedaliero-Universitaria di Parma - Ematologia e CTMO
🇮🇹Parma, PR, Italy
Grande Ospedale Metropolitano
🇮🇹Reggio Calabria, RC, Italy
Ospedale infermi di Rimini
🇮🇹Rimini, RN, Italy
AOU San Giovannidi Dio e Ruggi - ematologia
🇮🇹Salerno, SA, Italy
Università di Torino - Ospedale San Luigi Gonzaga
🇮🇹Orbassano, TO, Italy
AOC di Ematologia - AOU Senese
🇮🇹Siena, SI, Italy
A.O. Ordine Mauriziano Torino
🇮🇹Torino, TO, Italy
AOU Città della Salute e della Scienza di Torino
🇮🇹Torino, TO, Italy
Divisione di Ematologia - Università di Udine
🇮🇹Udine, UD, Italy
AO Universitaria Federico II
🇮🇹Napoli, Italy
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
AOU Santa Maria della Misericordia - Ematologia
🇮🇹Perugia, Italy
AOU Maggiore della carità
🇮🇹Novara, Italy
AOU Universitaria Arcispedale Sant'Anna
🇮🇹Cona, Ferrara, Italy
Irccs Crob
🇮🇹Rionero In Vulture, Potenza, Italy
AOU Policlinico Gaetano Martino
🇮🇹Messina, ME, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
🇮🇹Milano, MI, Italy