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AMLFLAMNCT03547258

Italian Non-Interventional Study of FLT3 Mutated AML Patients

An observational study of AML and FLT3-ITD Mutation, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 33 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
AML, FLT3-ITD Mutation, FLT3-TKD Mutation
What is being tested?
Clinical and Molecular data collection
How many people
800 participants
Where
33 sitesItaly
Study dates
18 Jul 2018to May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

33 sites in 1 country.

Oriana Nanni contact

+390543739266

oriana.nanni@irst.emr.it

33 sites in 1 country

Italy33 sites, 33 recruiting

  • AOU Ospedali riuniti di Ancona

    Ancona, AN, 60126

    Attilio Olivieri

    Recruiting

  • AOU Policlinico Bari - Ematologia

    Bari, BA, 70124

    Francesco Albano

    Recruiting

  • Università di Bologna - DIMES

    Bologna, BO, 40138

    Cristina Papayannidis

    Recruiting

  • ASST Spedali di Brescia

    Brescia, BS, 25123

    Chiara Cattaneo

    Recruiting

  • Azienda Ospedaliera G. Brotzu

    Cagliari, CA, 09121

    Claudio Romani

    Recruiting

  • Ematologia - Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro

    Catanzaro, CZ, 88100

    Stefano Molica

    Recruiting

  • AOU Universitaria Arcispedale Sant'Anna

    Cona, Ferrara, 44124

    Gian Matteo Rigolin, Prof

    Recruiting

  • Azienda Ospedaliera S. Croce e Carle

    Cuneo, CN, 12100

    Daniele Mattei

    Recruiting

  • AOU Careggi

    Florence, FI, 50134

    Alberto Bosi

    Recruiting

  • Ospedale Vito Fazzi di Lecce

    Lecce, LE, 73100

    Nicola Di Renzo, DR

    Recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    Meldola, FC, 47014

    Giovanni Martinelli, MD, 0390543739100, giovanni.martinelli@irst.emr.it

    Maria Benedetta Giannini, MD

    Recruiting

  • AOU Policlinico Gaetano Martino

    Messina, ME, 98125

    Caterina Musolino

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, MI, 20122

    Nicola Stefano Fracchiolla, MD

    Recruiting

  • Ospedale San Raffaele

    Milan, MI, 20132

    Fabio Ciceri

    Recruiting

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

    Elisabetta Todisco

    Recruiting

  • AO Universitaria Federico II

    Naples, 80131

    Fabrizio Pane

    Recruiting

  • AOU Maggiore della carità

    Novara, 28100

    Monia Lunghi, MD, PhD

    Recruiting

  • Università di Torino - Ospedale San Luigi Gonzaga

    Orbassano, TO, 10043

    Daniela Cilloni

    Recruiting

  • Ospedali Riuniti Villa Sofia-Cervello

    Palermo, PA, 90146

    Francesco Fabbiano

    Recruiting

  • Azienda Ospedaliero-Universitaria di Parma - Ematologia e CTMO

    Parma, PR, 43125

    Giovanni Roti

    Recruiting

  • AOU Santa Maria della Misericordia - Ematologia

    Perugia, 06129

    Maria Paola Martelli, Prof.ssa

    Recruiting

  • Ospedale "Guglielmo da Saliceto"

    Piacenza, PC, 29121

    Daniele Vallisa

    Recruiting

  • UO Ematologia, Ospedale S.Maria delle Croci

    Ravenna, RA, 48121

    Francesco Lanza, MD

    Recruiting

  • Grande Ospedale Metropolitano

    Reggio Calabria, RC, 89123

    Esther Oliva

    Recruiting

  • Ospedale infermi di Rimini

    Rimini, RN, 47923

    Anna Maria Mianulli, MD

    Recruiting

  • Irccs Crob

    Rionero in Vulture, Potenza, 85028

    Pellegrino Mustu

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168

    Simona Sica, Prof

    Recruiting

  • AOU San Giovannidi Dio e Ruggi - ematologia

    Salerno, SA, 84131

    Carmine Selleri

    Recruiting

  • IRCCS Casa sollievo della sofferenza

    San Giovanni Rotondo, FG, 71013

    Nicola Cascavilla, DR

    Recruiting

  • AOC di Ematologia - AOU Senese

    Siena, SI, 53100

    Monica Bocchia

    Recruiting

  • AOU Città della Salute e della Scienza di Torino

    Torino, TO, 10126

    Ernesta Audisio

    Recruiting

  • A.O. Ordine Mauriziano Torino

    Torino, TO, 10128

    Alessandro Cignetti

    Recruiting

  • Divisione di Ematologia - Università di Udine

    Udine, UD, 33100

    Anna Candoni

    Recruiting

Other trials in Italy

About this study

Official title: Italian Non-Interventional Study of FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML) Patients

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

Read the 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.

Being tested
Clinical and Molecular data collection
Keywords
AML, Italian observational study, FLT3-ITD Mutation, FLT3-TKD Mutation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical and Molecular data collectionGenetic

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

Study groups in NCT03547258
Study groupRoleWhat they receive
AML patientsClinical and Molecular data collection of AML Patients with FLT3 mutations (ITD or TKD)
Receives: Genetic: Clinical and Molecular data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 24 months

  2. 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

    Measured: up to 24 months

Secondary outcomes (10)

  1. 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;

    Measured: up to 24 months

  2. 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.

    Measured: up to 24 months

  3. 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.

    Measured: up to 24 months

  4. 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

    Measured: up to 24 months

  5. 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;

    Measured: up to 24 months

  6. 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);

    Measured: up to 24 months

  7. 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;

    Measured: up to 24 months

  8. transplantation percentage

    percentage of FLT3 mutated AML patients undergoing transplantation

    Measured: up to 24 months

  9. 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

    Measured: up to 24 months

  10. 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

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start18 Jul 2018
  3. Primary completionMay 2021 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03547258
Sponsor's protocol ID
IRST204.01
Acronym
FLAM
Status last verified
Apr 2020
First submitted
11 May 2018
Last updated
21 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of AML and FLT3-ITD Mutation, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 33 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Oriana Nanni (+390543739266, oriana.nanni@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of patients FLT3 negative at diagnosis who relapse FLT3 positive; (time frame: up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03547258.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.

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