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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02618109
Other study ID # 2015-A00621-48
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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