Etude : GRAAPH-2014 (LALPh+) /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : GRAAPH-2014 (LALPh+)

Nom :

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 25/10/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Essai thérapeutique randomisé de phase III évaluant la diminution des doses de chimiothérapie en association avec du nilotinib (Tasigna ®) dans les LAL à chromosome de Philadelphie positive (Ph+) de l’adulte jeune (18-59 ans).

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C91 - Leucémie lymphoïde
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Objectif principal :
Non infériorité du bras expérimental (Bras B) par rapport au bras contrôle (Bras A) en termes de réponse moléculaire majeure (MMolR), à l’issue du 4èmecycle (MRD4).

Objectifs secondaires :
Comparaison du bras expérimental et du bras contrôle en termes de tolérance, d’ICR, de survie sans évènement et de survie globale.

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 : 1. Whose blood and bone marrow explorations have been completed before the steroids prephase
2. Aged 18-59 years old with newly-diagnosed non previously treated Ph+ ALL according to WHO 2008 criteria (confirmed diagnosis of the Philadelphia chromosome defined by the reciprocal translocation of chromosomes 9 and 22, t(9;22) and/or presence of the BCR-ABL molecular maker)
3. With ≥ 20% bone marrow blasts
4. With Eastern Cooperative Oncology Group (ECOG) Performans Status ≤ 3
5. With or without central nervous system (CNS) or testis involvement
6. Without evolving cancer (except basal cell carcinoma of the skin or "in situ" carcinoma of the cervix) or its chemo- or radio-therapy should be finished at least since 6 months.
7. Having received no previous treatment for this hematological disease (including IT injection)
8. Having signed written informed consent
9. With efficient contraception for women of childbearing age (excluding estrogens and IUD)
10. With health insurance coverage
11. Who have received (or being receiving) the recommended steroid prephase.
Note 1: Secondary ALL (antecedent of chemo- or radio-therapy) can be included Note 2: In case of high vascular risk (see section "study management") the patient will not be able to receive nilotinib unless an ultra sound Doppler of the neck and lower limbs has been performed during the pre-phase and treatment validated by the medical coordinators of the protocol via the secretariat.

Critères de non-inclusion : 1. Previously treated with Tyrosine Kinase Inhibitor (TKI)
2. With another active malignancy
3. With general or visceral contra-indication to intensive therapy (except if considered related to the ALL):
a) Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal range (ULN)
b) Total bilirubin > 1.5 x ULN
c) Creatinine > 1.5 x ULN or creatinine clearance <50 mL/mn
d) Serum amylase or lipase > 1.5 x ULN or antecedents of acute pancreatitis
4. With heart failure, including at least one of the following criteria:
a) Left ventricular ejection fraction (LVEF) <50% or below the lowest normal threshold, as determined by ECG or heart failure (NYHA grade III or IV)
b) Impossibility to measure the QT interval on ECG
c) Complete left bundle branch block
d) Pacemaker
e) Congenital long QT syndrome of known familial antecedents of long QT syndrome
f) Antecedents or current ventricular or atrial tachyarrhythmia, clinically significant
g) Baseline bradycardia (<50 bpm) clinically significant
h) Corrected QT interval (QTc)> 450 msec established on the mean of 3 baseline ECG
i) Antecedents of myocardial infarct in the past 6 months
j) Instable angor within the past 12 months
k) Any heart condition clinically significant (i.e. congestive heart failure, uncontrolled hypertension)
5. Active uncontrolled infection, any other concurrent disease deemed to interfere with the conduct of the study as judged by the investigator
6. Severe evolving infection, or known HIV or Human T-Lymphotropic Virus type I (HTLV1) seropositivity, or active infection by hepatitis B or C virus
7. Pregnant (beta-HCG) or nursing woman
8. Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least three months thereafter. Patient not willing to ensure not to beget a child during participation in the study and at least three months thereafter.
9. Having received an investigational treatment or participation in another trial within 30 days prior to entering this study.
10. Not able to bear with the procedures or the frequency of visits planned in the trial.
11. Unable to consent, under tutelage or curators, or judiciary safeguard
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02611492
Promoteur :
Assistance Publique Hôpitaux de Paris
Type de sponsor : Institutionnel
APHP - 3 avenue Victoria
75004 PARIS 04

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
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

Ouverture de l'essai : OUVERT

MAJ : 23/10/2019

Centre investigateur :
Clinique Tessier – Groupe AHNAC - 118 Avenue Désandrouin - 59300 VALENCIENNES

Investigateur :
Docteur Nathalie CAMBIER

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

Ouverture de l'essai : OUVERT

MAJ : 23/10/2019

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

Ouverture de l'essai : OUVERT

MAJ : 25/10/2019