Etude : LABMI /



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 : LABMI

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 28/01/2020
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Identification de nouveaux marqueurs immunologiques spécifiques de rechute dans la leucémie aigue lymphoblastique B de l’enfant

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C91 - Leucémie lymphoïde
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : B-acute lymphoblastic leukaemia (ALL) is the most common childhood malignancy. Despite enhancement of childhood B-ALL outcome, relapses remain difficult to treat. Several studies in adult acute myeloid leukaemia have shown that proliferation of immunosuppressive cells -particularly T regulatory (Treg) cells and deficient natural killer (NK) cells- was associated with poor response to chemotherapy. However, few studies have been done on childhood ALL and none on relapse of B-ALL. Moreover, a newly described immunosuppressive B cells subset (Breg cells) seems to have a role in oncogenesis in mice model, but its significance has never been evaluated in human cancers. The purpose of this study is to prospectively evaluate the immune status of children newly diagnosed with first relapse of B-cell ALL, and to compare results with those of children treated for B-ALL in complete remission. Classic lymphocytic phenotype, proportions of immunosuppressive cells (Treg cells, deficient NK cells, Cytotoxic T-lymphocyte-associated protein 4 and/or Programmed T cell death 1) and thymopoiesis will be evaluated. The investigators assume that increase of immunosuppressive cells proportions could be associated with B-ALL relapse.

Study arms:
- Relapse Group
Collection of blood samples will be done in newly diagnosed relapse of B-ALL children at the time of relapse diagnosis.
Children aged from 1 to 18 years at the time of first B-ALL relapse diagnosis.

- Control Group
Collection of blood samples will be done at the same stage of treatment as the relapse group has been collected.
Children aged from 1 to 18 years enrolled into FRALLE (protocol of treatment) or EORTC (European Organisation for Research and Treatment of Cancer) treatment protocols, treated for B-ALL and who are in complete molecular remission.
These control patients will be recruited at the same time from the beginning of B-ALL treatment as paired-relapsed control patients.


Current primary outcome:
Measure of Treg (CD4+,CD25+, Foxp3+) and deficient natural killer (NK) cells (CD3-,CD56+,NKp30-) proportions by FACS in children newly diagnosed with their first relapse of B-ALL. [ Time Frame: At the time of the inclusion. ]
Comparison of the immune status of patients at the diagnosis of their first relapse diagnosis with those of children treated for B-ALL who are in complete remission and at the same stage of treatment.

Current secondary oucomes:
- Measure of the number of T CD4+ lymphocytes (Cluster of Differentiation 4), T CD8+ lymphocytes (Cluster of Differentiation 8), NK cells and Natural killer T (NKT) cells by FACS. [ Time Frame: At the time of the inclusion. ]
- Measure of percentage of TCD4+ naive and memory cells and TCD8+ naive and memory cells by FACS. [ Time Frame: At the time of the inclusion. ]
- Measure of percentage of gamma delta and alpha-bêta TCR CD3+ T cells by FACS. [ Time Frame: At the time of the inclusion. ]
- Measure of TRECs (T cell receptor excision circle) by QPCR and naïve CD4+CD45RA+CD31+ T cells by FACS. [ Time Frame: At the time of the inclusion. ]


Phase : IV

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 : Inclusion Criteria for relapse Group :
- Children aged from 1 to 18 years at the time of first B-ALL relapse diagnosis
- Obtention of oral and written consent of the parents
- Parents affiliated with the social security system

Inclusion Criteria for control Group :
- Children aged from 1 to 18 years enrolled into FRALLE or EORTC treatment protocols, treated for B-ALL and who are in complete molecular remission
- Obtention of oral and written consent of the parents
- Parents affiliated with the social security system


Critères de non-inclusion : Exclusion criteria for control Group are the same as for relapsed Group :
- Children with hematologic syndrome predisposing to hematologic neoplasia (such as Fanconi's anaemia, Diamond Blackfan anaemia …) or acute leukemia secondary to previous treatment, or who have had allogenic hematopoietic stem cell transplantation before relapse

NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02618109
Promoteur :
CHU d'Angers
Type de sponsor : Institutionnel
4 rue Larrey
49000 ANGERS

Coordonnateur :
Professeur isabelle PELLIER
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 Brigitte NELKEN

TEC / ARC / IDE :
Amandine GORALSKI
amandine.goralski@
chru-lille.fr
03.20.44.60.58

Ouverture de l'essai : OUVERT

MAJ : 13/12/2019