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

University Hospital, Angers

Status and phase: Terminated; Phase 4

Conditions: Leukemia Relapse; B Acute Lymphoblastic Leukemia

Treatments: Biological: Collection of blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT02618109

2015-A00621-48

Details and patient eligibility

About

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.

Enrollment: 119 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

119 participants in 2 patient groups

Relapse Group

Other group

Description:

* 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.

Treatment:

Biological: Collection of blood samples

Control Group

Other group

Description:

* 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.

Treatment:

Biological: Collection of blood samples