Etude : FAST /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : FAST

Nom :

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 25/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : French Aspirin Study in Essential Thrombocythemia: an Open and Randomized Study

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C96 - Tumeurs malignes des tissus lymphoïde, hématopoïétique et apparentés, autres et non précisées
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The hypothesis is that efficient prevention of thrombosis with aspirin at diagnosis becomes less useful once patients have achieved a hematologic response (HR) (modified by amendment 1/03/2017) and/or that this benefit is hampered by an increased hemorrhagic risk especially in elderly patients.

Hence, investigator propose a prospective randomized study to assess the benefit / risk ratio of aspirin maintenance in high risk Essential thrombocythemia (ET) patients, in hematological response (modified by amendment 1/03/2017) on Hydroxyurea.


Study arms:
- Experimental: HU without aspirin
nterventions:
Other: Aspirin therapy interruption
Drug: Hydroxyurea treatment (HU)
- Active Comparator: HU + aspirin maintenance
Interventions:
Other: Usual treatment by aspirin 100 mg/d in the active comparator arm
Drug: Hydroxyurea treatment (HU)
- HU + AAG
Observational arm
Interventions:
Other: No interruption of aspirin in the Observational arm
Drug: Hydroxyurea treatment (HU)


Current primary outcome:
Cumulative incidence of death from vascular origin and other thrombotic and hemorrhagic events (combined endpoint) [ Time Frame: at 2-years follow-up ]

Current secondary outcomes:
- Cumulative incidence and characteristics of vascular complications: thrombosis and hemorrhage, (grade, site, recurrence), assessed yearly over a 5-year follow-up period. [ Time Frame: at 5 years ]
- Rate of hematological response every 6 months [ Time Frame: at 5 years ]
- Hematological response as assessed by European Leukemia Net (ELN) criteria, revised ELN International Working Group on Myeloproliferative Neoplasms Research and Treatment (ELN -IWG MRT).
- Adverse event (AE) frequency and incidence, comparison in the two arms [ Time Frame: at 5 years ]
- Number of HU-related nonhematologic toxicities [ Time Frame: at 5 years ]
- Cumulative incidence of thrombosis [ Time Frame: at 5 years ]
- Cumulative incidence of hemorrhagic complications [ Time Frame: at 5 years ]
- Estimation of the progression-free survival [ Time Frame: at 5 years ]
- Estimation of overall survival [ Time Frame: at 5 years ]
- Short Form 36 (SF36) Health Survey [ Time Frame: through study completion, an average of 1 year ]
- Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) [ Time Frame: through study completion, an average of 1 year ]
- Number of mortality cause. [ Time Frame: at 5 years ]
- Cumulative incidence of progression to polyglobulia [ Time Frame: at 5 years ]
- Cumulative incidence of progression to myelofibrosis (MF) [ Time Frame: at 5 years ]
- Cumulative incidence of progression to myelodysplastic syndrome (MDS) [ Time Frame: at 5 years ]
- Cumulative incidence of progression AML [ Time Frame: at 5 years ]
- Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden (in blood DNA) in patients presenting thrombosis or not . [ Time Frame: at 5 years ]
- Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patients in persistent hematological response (modified by amendment 1/03/2017). [ Time Frame: at 5 years ]
- Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patient who will lose their hematological response (modified by amendment 1/03/2017). [ Time Frame: at 5 years ]
- Frequencies of mutations (JAK2V617F, MPLw515 and CALR) and JAK2V617F allele burden, MPLw515 allele burden and CALR mutation allele burden in patients presenting intolerance to treatment. [ Time Frame: at 5 years ]

Phase : III

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - > 18 years and older (modified by amendment 01/03/2017)
- Contraception considered effective by the investigator: for women of childbearing and for men whose partner is likely to procreate (added by amendment 01/03/2017)
- Diagnosis of ET performed within the last 10 years (modified by amendment 01/03/2017) : with or without Janus kinase 2V617F (JAK2V617F) mutation according to the WHO 2008 criteria (TEFFERI,2007)
- ET patients currently treated with hydroxyurea in first line, who have achieved a complete or partial hematologic response according to the ELN 2009 (BAROSI, 2009) modified (at least three month apart and at inclusion) (modified by amendment 01/03/2017)
- Signed Written Informed Consent
- Health insurance coverage.

Critères de non-inclusion : - Other myeloproliferative disorder than ET.
- Contra-indication to hydroxyurea.
- Other uncontrolled malignancies at the time of diagnosis or inclusion.
- History of haemostasis perturbation not related to ET, associated with a significant risk of hemorrhage or thrombosis (modified by amendment 01/03/2017)
- Pregnancy or breastfeeding (added by amendment 01/03/2017)
- Inability to freely provide consent through judiciary or administrative condition.
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02611973
Promoteur :
APHP
Type de sponsor : Institutionnel
APHP
75010 PARIS 10

Coordonnateur :
Professeur Stéphane GIRAUDIER
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Nathalie CAMBIER

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Ouverture de l'essai : OUVERT

MAJ : 15/10/2019

Centre investigateur :
Centre Hospitalier de Valenciennes - Avenue Désandrouin - CS 50479 - 59300 VALENCIENNES

Investigateur :
Docteur Nathalie CAMBIER

TEC / ARC / IDE :
Madame Marielle FERY
fery-m@
ch-valenciennes.fr
03 27 14 07 15

Ouverture de l'essai : OUVERT

MAJ : 17/10/2019

Centre investigateur :
Centre Hospitalier de Lens - 99 Route de la Bassée - 62300 LENS

Investigateur :
Docteur Brigitte DUPRIEZ

TEC / ARC / IDE :
Hervé DECLERCQ
hdeclercq@ch-lens.fr
03 21 69 19 16

Ouverture de l'essai : OUVERT

MAJ : 25/10/2019