Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia

B Acute Lymphoblastic Leukemia Clinical Trial

— LABMI  

Official title:

Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02618109
• Other study ID #: 2015-A00621-48
• Status: Terminated
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: September 2022

Study information

• Verified date: September 2022
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 119
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

1. 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

2. 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

3. 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

Related Conditions & MeSH terms

• B Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia Relapse
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Recurrence

Intervention

Biological:
• Collection of blood samples
Collection of blood samples

Locations

Country	Name	City	State
France	University Hospital of Amiens	Amiens
France	University Hospital of Angers	Angers
France	University Hospital of Besancon	Besançon
France	University Hospital of Bordeaux	Bordeaux
France	University Hospital of Caen	Caen
France	Civil Hospices of Lyon	Lyon
France	University Hospital of Marseille	Marseille
France	University Hospital of Nancy	Nancy
France	University Hospital of Nantes	Nantes
France	University Hospital of Nice	Nice
France	University Hospital of Robert Debre (Paris)	Paris
France	University Hospital of Trousseau (Paris)	Paris
France	University Hospital of Reims	Reims
France	University Hospital of Rennes	Rennes
France	University Hospital of Saint Etienne	Saint-Étienne
France	University Hospital of Strasbourg	Strasbourg
France	University Hospital of Toulouse	Toulouse
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	At the time of the inclusion.
Secondary	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.		At the time of the inclusion.
Secondary	Measure of percentage of TCD4+ naive and memory cells and TCD8+ naive and memory cells by FACS.		At the time of the inclusion.
Secondary	Measure of percentage of gamma delta and alpha-bêta TCR CD3+ T cells by FACS.		At the time of the inclusion.
Secondary	Measure of TRECs (T cell receptor excision circle) by QPCR and naïve CD4+CD45RA+CD31+ T cells by FACS.		At the time of the inclusion.