B Acute Lymphoblastic Leukemia, Leukemia Relapse
Conditions
Keywords
B acute lymphoblastic leukemia, leukemia relapse, pediatric onco-hematology
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.
Interventions
BIOLOGICALCollection of blood samples
Collection of blood samples
Sponsors
University Hospital, Angers
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 percentage of TCD4+ naive and memory cells and TCD8+ naive and memory cells by FACS. | At the time of the inclusion. |
| Measure of percentage of gamma delta and alpha-bêta TCR CD3+ T 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. |
Countries
France
Outcome results
None listed