FLAM: Italian Non-Interventional Study of FLT3 Mutated AML Patients

Sponsor

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori (Other)

Overall Status

Unknown status

CT.gov ID

NCT03547258

Collaborator

(none)

800

Enrollment

Locations

33.4

Anticipated Duration (Months)

24.2

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
AML FLT3-ITD Mutation FLT3-TKD Mutation	Genetic: Clinical and Molecular data collection

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:

Retrospective phase: clinical and molecular data of AML patients with FLT3+ mutations detected at diagnosis or at any refractory/relapse state will be collected.
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jul 18, 2018

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
AML patients Clinical and Molecular data collection of AML Patients with FLT3 mutations (ITD or TKD)	Genetic: Clinical and Molecular data collection Clinical and Molecular data collection at diagnosis, during treatment and at each relapse

Arm

Intervention/Treatment

AML patients

Clinical and Molecular data collection of AML Patients with FLT3 mutations (ITD or TKD)

Genetic: Clinical and Molecular data collection

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

Outcome Measures

Primary Outcome Measures

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

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.
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.
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
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);
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;
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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.

Exclusion criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AOU Ospedali riuniti di Ancona	Ancona	AN	Italy	60126
2	AOU Policlinico Bari - Ematologia	Bari	BA	Italy	70124
3	Università di Bologna - DIMES	Bologna	BO	Italy	40138
4	ASST Spedali di Brescia	Brescia	BS	Italy	25123
5	Azienda Ospedaliera G. Brotzu	Cagliari	CA	Italy	09121
6	Azienda Ospedaliera S. Croce e Carle	Cuneo	CN	Italy	12100
7	Ematologia - Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro	Catanzaro	CZ	Italy	88100
8	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)	Meldola	FC	Italy	47014
9	AOU Universitaria Arcispedale Sant'Anna	Cona	Ferrara	Italy	44124
10	IRCCS Casa sollievo della sofferenza	San Giovanni Rotondo	FG	Italy	71013
11	AOU Careggi	Firenze	FI	Italy	50134
12	Ospedale Vito Fazzi di Lecce	Lecce	LE	Italy	73100
13	AOU Policlinico Gaetano Martino	Messina	ME	Italy	98125
14	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano	MI	Italy	20122
15	Ospedale San Raffaele	Milano	MI	Italy	20132
16	Istituto Europeo di Oncologia	Milano	MI	Italy	20141
17	Ospedali Riuniti Villa Sofia-Cervello	Palermo	PA	Italy	90146
18	Ospedale "Guglielmo da Saliceto"	Piacenza	PC	Italy	29121
19	Irccs Crob	Rionero In Vulture	Potenza	Italy	85028
20	Azienda Ospedaliero-Universitaria di Parma - Ematologia e CTMO	Parma	PR	Italy	43125
21	UO Ematologia, Ospedale S.Maria delle Croci	Ravenna	RA	Italy	48121
22	Grande Ospedale Metropolitano	Reggio Calabria	RC	Italy	89123
23	Ospedale infermi di Rimini	Rimini	RN	Italy	47923
24	AOU San Giovannidi Dio e Ruggi - ematologia	Salerno	SA	Italy	84131
25	AOC di Ematologia - AOU Senese	Siena	SI	Italy	53100
26	Università di Torino - Ospedale San Luigi Gonzaga	Orbassano	TO	Italy	10043
27	AOU Città della Salute e della Scienza di Torino	Torino	TO	Italy	10126
28	A.O. Ordine Mauriziano Torino	Torino	TO	Italy	10128
29	Divisione di Ematologia - Università di Udine	Udine	UD	Italy	33100
30	AO Universitaria Federico II	Napoli		Italy	80131
31	AOU Maggiore della carità	Novara		Italy	28100
32	AOU Santa Maria della Misericordia - Ematologia	Perugia		Italy	06129
33	Fondazione Policlinico Universitario Agostino Gemelli	Roma		Italy	00168

Sponsors and Collaborators

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Investigators

Study Chair: Giovanni Martinelli, MD, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

ClinicalTrials.gov Identifier:

NCT03547258

Other Study ID Numbers:

IRST204.01

First Posted:

Jun 6, 2018

Last Update Posted:

Apr 21, 2020

Last Verified:

Apr 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

AML

Italian observational study

FLT3-ITD Mutation

FLT3-TKD Mutation

Study Results

No Results Posted as of Apr 21, 2020