Etude : EQUAALL01 /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : EQUAALL01

Situation thérapeutique :

Traitement :

Cadre réglementaire : RIPH3

Dernière MÀJ : 25/01/2022
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Evaluation de l’état de santé à long-terme et de la qualité de vie de patients adultes survivants traités intensivement pour une leucémie aiguë lymphoblastique Philadelphia-négative dans un protocole d’inspiration pédiatrique

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C91 - Leucémie lymphoïde

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C85 - Lymphome non hodgkinien, de types autres et non précisés
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : The overall survival of adult patients (15-59y) with Philadelphia-negative acute lymphoblastic leukemia/lymphoma (ALL/LL) was dramatically improved by the use of full pediatric or pediatric-inspired protocols (GRAALL2003/05-LL03-FRALLE2000) that aimed to reduce the risk of relapse by adopting more intensive chemotherapeutical schedule. This approach led to a global improvement in overall survival (5y-OS, 57%) whatever patient age but was responsible for an excess of treatment-related mortality in patients older than 45 years (5y-TRM in patients > 45y, 19%). Pediatric longitudinal studies pointed out that long term leukemia survivors have an increased risk of developing specific adverse events like dysmetabolic syndrome, obesity, decreased fertility, organ dysfunction, osseous events, or impaired cognitive functions. This study aims to evaluate the impact in term of long-term events and QoL in adult patients that received an intensified therapeutic approach recently implemented in adult cooperative groups. The main objective of this study is to evaluate the prevalence of late effects in adult patients treated 10 years ago for ALL/LL with an intensified pediatric-inspired protocol (GRAALL2003/05-LL03-FRALLE2000) that exposed patients to increased cumulative doses of chemotherapy, central nervous system irradiation or w/o allogeneic transplant after total body irradiation-based regimen w/o boost irradiation on central nevous system. One of the secondary endpoint of the study is to assess quality of life of these patients.

STUDY POPULATION:
Adult patients aged 15-59y at diagnosis treated ten years ago for a Ph1-negative acute lymphoblastic leukemia/lymphoma (ALL/LL)

CURRENT PRIMARY OUTCOME:
Prevalence of adverse events [ Time Frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant. ]
This is a binary, composite, endpoint, including any of the following adverse events:
-metabolic troubles (dysmetabolic syndrome, dyslipidemia, diabetes)
-osseous events /osteoporosis
-cardiac and vascular troubles
-neurologic troubles
-lung dysfunctions
-endocrinal troubles

CURRENT SECONDARY OUTCOMES:
- Prevalence of metabolic troubles [ Time Frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant. ]
- Prevalence of osseous events [ Time Frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant. ]
- Prevalence of cardiac and vascular troubles [ Time Frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant. ]
- Prevalence of neurologic troubles [ Time Frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant. ]
- Prevalence of lung dysfunctions [ Time Frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant. ]
- Prevalence of endocrinal troubles [ Time Frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant. ]
- Quality of Life [ Time Frame: Up to 3 months post inclusion (10 years from first complete remission of a ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant. ]

Phase : NA

Stade : NA

1 (hémato), Rechute, Réfractaire
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 : - Patient with Philadelphia-negative ALL or LL treated in or according to a pediatric-like or pediatric-inspired protocol (GRAALL03/05-LL03-FRALLE2000) with or without allogeneic transplant.
- Patients older than 15 years old and less than 60 years old at diagnosis
- Patient with a follow-up from first complete remission of more than 10 years,
- Patient who gave informed signed consent for baseline examination

Critères de non-inclusion : - Patient who experienced ALL/LL relapse within the 5 past years.
- Philadelphia positive ALL patients
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04677231
Promoteur :
APHP
Type de sponsor : Institutionnel
75010 PARIS 10

Coordonnateur :
professeur Nicolas BOISSEL
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 Céline BERTHON

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

Statut de l'essai : OUVERT

MAJ : 07/06/2021

Centre investigateur :
Centre Hospitalier de Roubaix - 11 Boulevard Lacordaire - 59100 ROUBAIX

Investigateur :
Docteur Isabelle PLANTIER

TEC / ARC / IDE :
Kathy DERNIVOIX
kathy.dernivoix@
ch-roubaix.fr
+33 3 20 99 31 31 | POSTE 6904 DECT 17685

Statut de l'essai : OUVERT

MAJ : 25/01/2022

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

Investigateur :
Docteur Laure STALNIKIEWICZ

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

Statut de l'essai : OUVERT

MAJ : 19/01/2022