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

Phase 4

Terminated

• Conditions: Leukemia Relapse; B Acute Lymphoblastic Leukemia
• Interventions: Biological: Collection of blood samples

• Registration Number: NCT02618109
• Lead Sponsor: University Hospital, Angers

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-15
• Study First Submitted QC: 2015-11-26
• Study First Posted: 2015-12-01
• Study Start: 2016-01
• Status Verified: 2022-09
• Primary Completion: 2022-09
• Study Completion: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relapse Group	Collection of blood samples	* 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	* 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.

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Measure of percentage of gamma delta and alpha-bêta TCR CD3+ T cells by FACS.	At the time of the inclusion.
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.
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.
Measure of percentage of TCD4+ naive and memory cells and TCD8+ naive and memory cells by FACS.	At the time of the inclusion.

Trial Locations

Locations (18)

University Hospital of Marseille; 🇫🇷 Marseille, France

University Hospital of Nantes; 🇫🇷 Nantes, France

University Hospital of Besancon; 🇫🇷 Besançon, France

University Hospital of Angers; 🇫🇷 Angers, France

University Hospital of Bordeaux; 🇫🇷 Bordeaux, France

University Hospital of Amiens; 🇫🇷 Amiens, France

University Hospital of Caen; 🇫🇷 Caen, France

Civil Hospices of Lyon; 🇫🇷 Lyon, France

University Hospital of Tours; 🇫🇷 Tours, France

University Hospital of Nancy; 🇫🇷 Nancy, France

University Hospital of Nice; 🇫🇷 Nice, France

University Hospital of Rennes; 🇫🇷 Rennes, France

University Hospital of Trousseau (Paris); 🇫🇷 Paris, France

University Hospital of Robert Debre (Paris); 🇫🇷 Paris, France

University Hospital of Saint Etienne; 🇫🇷 Saint-Étienne, France

University Hospital of Reims; 🇫🇷 Reims, France

University Hospital of Strasbourg; 🇫🇷 Strasbourg, France

University Hospital of Toulouse; 🇫🇷 Toulouse, France