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

NCT ID: NCT02618109

Last Updated: 2022-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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B Acute Lymphoblastic Leukemia Leukemia Relapse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Relapse Group

* 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.

Group Type OTHER

Collection of blood samples

Intervention Type BIOLOGICAL

Collection of blood samples

Control Group

* 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.

Group Type OTHER

Collection of blood samples

Intervention Type BIOLOGICAL

Collection of blood samples

Interventions

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Collection of blood samples

Collection of blood samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle PELLIER, PU-PH

Role: PRINCIPAL_INVESTIGATOR

UNIVERSITY HOSPITAL OF ANGERS

Locations

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University Hospital of Amiens

Amiens, , France

Site Status

University Hospital of Angers

Angers, , France

Site Status

University Hospital of Besancon

Besançon, , France

Site Status

University Hospital of Bordeaux

Bordeaux, , France

Site Status

University Hospital of Caen

Caen, , France

Site Status

Civil Hospices of Lyon

Lyon, , France

Site Status

University Hospital of Marseille

Marseille, , France

Site Status

University Hospital of Nancy

Nancy, , France

Site Status

University Hospital of Nantes

Nantes, , France

Site Status

University Hospital of Nice

Nice, , France

Site Status

University Hospital of Trousseau (Paris)

Paris, , France

Site Status

University Hospital of Robert Debre (Paris)

Paris, , France

Site Status

University Hospital of Reims

Reims, , France

Site Status

University Hospital of Rennes

Rennes, , France

Site Status

University Hospital of Saint Etienne

Saint-Etienne, , France

Site Status

University Hospital of Strasbourg

Strasbourg, , France

Site Status

University Hospital of Toulouse

Toulouse, , France

Site Status

University Hospital of Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00621-48

Identifier Type: -

Identifier Source: org_study_id

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