AML Clinical Trial
— FLAMOfficial title:
Italian Non-Interventional Study of FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML) Patients
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 |
This is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with AML with FLT3+ mutations
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori |
Italy,
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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