Etude : GRAALL-2014/T /

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.

Type d'étude
Présentation de l'étude
Acronyme : GRAALL-2014/T

Nom :

Traitement :

Type d'étude : Hors ciblage moléculaire

Dernière MÀJ : 20/05/2019
CIM10 - Localisation(s)
Informations principales
Titre : Multicenter Study of Risk-adapted Treatment for T-lineage ALL of Young Adults (18-59 Years Old): Evaluating the Efficacy of a Nelarabine Based Consolidation and Maintenance in High-risk Patients

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C91 - Leucémie lymphoïde
Informations complémentaires
Schéma : The purpose of this study is to evaluate the efficacy of nelarabine-based consolidation and maintenance therapy in term of relapse-free survival (RFS) in high-risk (HR) patients.

Study arms:
Experimental: High-Risk (HR) patients
Nelarabine during consolidation and maintenance

Intervention: Drug: nelarabine
Nelarabine 1500 mg/m2/d (IV 2h) : D1, D3, D5 Cyclophosphamide 150 mg/m2/d (IV 3h) : D1, D3 etoposide (VP-16) 75 mg/m2/d (IV 1h) : D1, D3 granulocyte-colony stimulating factor 5 µg/kg/d (SC) : D7 until neutrophil >1 Giga/Liter
for a maximum of 5 blocks

Current primary outcome:
Disease free survival (DFS) [ Time Frame: 4 years ]

Current secondary outcomes:
- Overall survival [ Time Frame: 4 years ]
- Cumulative incidence of relapse [ Time Frame: 4 years ]
- Non relapse mortality (NRM) [ Time Frame: 4 years ]
- Disease free survival censored at allograft in first complete remission (CR) [ Time Frame: 4 years ]
- Cumulative incidence of relapse censored at allograft in first complete remission (CR) [ Time Frame: 4 years ]
- Overall survival censored at allograft in first complete remission (CR) [ Time Frame: 4 years ]
- Non relapse mortality (NRM) censored at allograft in first complete remission (CR) [ Time Frame: 4 years ]
- Minimal residual disease (MRD) [ Time Frame: within 1 year ]
- Proportion of patients having received the 5 cycles of nelarabine [ Time Frame: 3 years ]

Phase : II

Stade : NA

Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Whose blood and bone marrow explorations have been completed before the steroids prephase
- aged 18-59 years old with a not previously treated (including IT injection) T-ALL newly-diagnosed according to the WHO 2008 definition with > 20% bone marrow blasts
- With Eastern Cooperative Oncology Group (ECOG) performance status < 3
- With or without central nervous system (CNS) involvement or testis
- Without other evolving cancer (except basal cell carcinoma of the skin and "in situ" carcinoma of the cervix) or its chemo or radio-therapy treatment finished at least since 6 months
- Having signed a written informed consent
- With efficient contraception for women of childbearing age (excluding estrogens and IUD)
- Having received or being receiving steroid prephase
- With health insurance coverage

Critères de non-inclusion : - With lymphoblastic lymphoma and bone marrow blasts < 20%, Burkitt-type ALL or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm
- With contra-indication to anthracyclines or any other general or visceral contra-indication to intensive therapy except if considered related to the ALL:
> Aspartate transaminase (AST) and/or alanine transaminase (ALT) > 5 x upper limit of normal range (ULN)
> Total bilirubin ≥ 2.5 x upper limit of normal range (ULN)
> Creatinine > 1.5 x upper limit of normal range (ULN) or creatinine clearance <50 mL/mn
- Myocardial infarction within 6 months prior to inclusion in the trial, cardiomyopathy (NYHA grade III or IV), left ejection ventricle fraction (LEVF) < 50% and/or RF < 30%,
- Active severe infection or known seropositivity for HIV or Human T cell leukemia/lymphoma virus type 1 (HTLV-1) or active hepatitis B or C
- Other active malignancy
- Pregnant (beta-Human Chorionic Gonadotropin (hCG) positive) or nursing woman
- Women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least three months thereafter. Patients not willing to ensure not to beget a child during participation in the study and at least three months thereafter
- Treated with any other investigational agent or participation in another trial within 30 days prior to entering this study
- Not able to bear with the procedures or the frequency of visits planned in the trial
- Unable to consent, under tutelage or curators, or judiciary safeguard
Informations relatives au promoteur
Promoteur :
Type de sponsor : Institutionnel
75010 PARIS 10

Coordonnateur :
Professeur Hervé DOMBRET
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Docteur Céline BERTHON

Secrétariat de recherche

Ouverture de l'essai : OUVERT

MAJ : 20/05/2019