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

September 29, 2022 updated by: University Hospital, Angers
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France, 80054
        • University Hospital of Amiens
      • Angers, France, 49933
        • University hospital of Angers
      • Besançon, France, 25030
        • University Hospital of Besancon
      • Bordeaux, France, 33000
        • University Hospital of Bordeaux
      • Caen, France, 14033
        • University hospital of Caen
      • Lyon, France, 69008
        • Civil Hospices of Lyon
      • Marseille, France, 13385
        • University Hospital of Marseille
      • Nancy, France, 54511
        • University Hospital of Nancy
      • Nantes, France, 44000
        • University Hospital of Nantes
      • Nice, France, 06202
        • University Hospital of Nice
      • Paris, France, 75571
        • University Hospital of Trousseau (Paris)
      • Paris, France, 75935
        • University Hospital of Robert Debre (Paris)
      • Reims, France, 51092
        • University Hospital of Reims
      • Rennes, France, 35203
        • University Hospital of Rennes
      • Saint-Étienne, France, 42055
        • University Hospital of Saint Etienne
      • Strasbourg, France, 67098
        • University Hospital of Strasbourg
      • Toulouse, France, 31059
        • University Hospital of Toulouse
      • Tours, France, 37000
        • University hospital of Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Biological: Collection of blood samples
Collection of blood samples
Other: 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.
Biological: Collection of blood samples
Collection of blood samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
At the time of the inclusion.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Isabelle PELLIER, PU-PH, University hospital of Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

April 15, 2015

First Submitted That Met QC Criteria

November 26, 2015

First Posted (Estimate)

December 1, 2015

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A00621-48

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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