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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03547258
Other study ID # IRST204.01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 18, 2018
Est. completion date May 2021

Study information

Verified date April 2020
Source Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Contact Oriana Nanni
Phone +390543739266
Email oriana.nanni@irst.emr.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3+ mutations


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 information / eligibility

Status Recruiting
Enrollment 800
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

1. AML patients

2. Male or Female

3. Aged = 18 years

4. FLT3 mutations (ITD or TKD) positive tests performed at diagnosis or at relapse.

5. Participant is willing and able to give informed consent for participation in the study.

Exclusion criteria:

1. To be currently involved in experimental clinical protocol, or have been treated with experimental drugs are not exclusion criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Genetic:
Clinical and Molecular data collection
Clinical and Molecular data collection at diagnosis, during treatment and at each relapse

Locations

Country Name City State
Italy AOU Ospedali riuniti di Ancona Ancona AN
Italy AOU Policlinico Bari - Ematologia Bari BA
Italy Università di Bologna - DIMES Bologna BO
Italy ASST Spedali di Brescia Brescia BS
Italy Azienda Ospedaliera G. Brotzu Cagliari CA
Italy Ematologia - Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro Catanzaro CZ
Italy AOU Universitaria Arcispedale Sant'Anna Cona Ferrara
Italy Azienda Ospedaliera S. Croce e Carle Cuneo CN
Italy AOU Careggi Firenze FI
Italy Ospedale Vito Fazzi di Lecce Lecce LE
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Meldola FC
Italy AOU Policlinico Gaetano Martino Messina ME
Italy Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano MI
Italy Istituto Europeo di Oncologia Milano MI
Italy Ospedale San Raffaele Milano MI
Italy AO Universitaria Federico II Napoli
Italy AOU Maggiore della carità Novara
Italy Università di Torino - Ospedale San Luigi Gonzaga Orbassano TO
Italy Ospedali Riuniti Villa Sofia-Cervello Palermo PA
Italy Azienda Ospedaliero-Universitaria di Parma - Ematologia e CTMO Parma PR
Italy AOU Santa Maria della Misericordia - Ematologia Perugia
Italy Ospedale "Guglielmo da Saliceto" Piacenza PC
Italy UO Ematologia, Ospedale S.Maria delle Croci Ravenna RA
Italy Grande Ospedale Metropolitano Reggio Calabria RC
Italy Ospedale infermi di Rimini Rimini RN
Italy Irccs Crob Rionero In Vulture Potenza
Italy Fondazione Policlinico Universitario Agostino Gemelli Roma
Italy AOU San Giovannidi Dio e Ruggi - ematologia Salerno SA
Italy IRCCS Casa sollievo della sofferenza San Giovanni Rotondo FG
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

Sponsors (1)

Lead Sponsor Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 objective overall response rate (ORR) 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; up to 24 months
Secondary disease-free survival (DFS) 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. up to 24 months
Secondary overall survival (OS) overall survival (OS) defined as the time since date of diagnosis until death for any cause or the last available patient contact. up to 24 months
Secondary Percentage of AML patients with specific types of FLT3 mutations Percentage of AML patients with specific types of FLT3 mutations, at initial diagnosis and at disease relapse up to 24 months
Secondary distribution of specific FLT3 mutations in AML patients 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; up to 24 months
Secondary frequency of the different methods used to evaluate (Minimal residual disease) MRD 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); up to 24 months
Secondary FLT3-ITD allelic ratio 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; up to 24 months
Secondary transplantation percentage percentage of FLT3 mutated AML patients undergoing transplantation up to 24 months
Secondary evaluation of modifications in terms of quality of life (QoL) of patients with FLT3 mutated AML 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 up to 24 months
Secondary retrospective collection of surrogate measures of QoL 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 up to 24 months
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