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Trial record 5 of 29945 for:    Immunologic Factors

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

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ClinicalTrials.gov Identifier: NCT02618109
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
B Acute Lymphoblastic Leukemia Leukemia Relapse Biological: Collection of blood samples Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia
Study Start Date : January 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. Measure of percentage of gamma delta and alpha-bêta TCR CD3+ T cells by FACS. [ Time Frame: At the time of the inclusion. ]
  4. 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. ]


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618109


Contacts
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Contact: Isabelle PELLIER, PU-PH ispellier@chu-angers.fr
Contact: Elsa BERARDI elberardi@chu-angers.fr

Locations
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France
University Hospital of Amiens Recruiting
Amiens, France, 80054
Contact: Catherine DEVOLDERE, MD       Devoldere.catherine@chu-amiens.fr   
University Hospital of Angers Recruiting
Angers, France, 49933
Contact: Isabelle PELLIER, PU-PH       ispellier@chu-angers.fr   
University Hospital of Besancon Recruiting
Besançon, France, 25030
Contact: Pauline SIMON, MD       P1simon@chu-besancon.fr   
University Hospital of Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Charlotte JUBERT, MD       Charlotte.jubert@chu-bordeaux.fr   
University Hospital of Caen Recruiting
Caen, France, 14033
Contact: Odile MINCKES, MD       minckes-o@chu-caen.fr   
Civil Hospices of Lyon Recruiting
Lyon, France, 69008
Contact: Yves BERTRAND, PU-PH       yves.bertrand@chu-lyon.fr   
University Hospital of Marseille Recruiting
Marseille, France, 13385
Contact: Gerard MICHEL, PU-PH       gerard.michel@ap-hm.fr   
University Hospital of Nancy Recruiting
Nancy, France, 54511
Contact: Claudine SCHMITT, MD       c.schmitt@chru-nancy.fr   
University Hospital of Nantes Recruiting
Nantes, France, 44000
Contact: Caroline THOMAS, MD       caroline.thomas@chu-nantes.fr   
University Hospital of Nice Recruiting
Nice, France, 06202
Contact: Pierre-Simon ROHRLICH, PU-PH       rohrlich.ps@chu-nice.fr   
University Hospital of Trousseau (Paris) Recruiting
Paris, France, 75571
Contact: Arnaud PETIT, PU-PH       arnaud.petit@trs.aphp.fr   
University Hospital of Robert Debre (Paris) Recruiting
Paris, France, 75935
Contact: André BARUCHEL, PU-PH       andre.baruchel@rdb.aphp.fr   
University Hospital of Reims Recruiting
Reims, France, 51092
Contact: Claire PLUCHART, MD       cpluchart@chu-reims.fr   
University Hospital of Rennes Recruiting
Rennes, France, 35203
Contact: Virginie GANDEMER, PU-PH       virginie.gandemer@chu-rennes.fr   
University Hospital of Saint Etienne Recruiting
Saint-Étienne, France, 42055
Contact: Sandrine THOUVENIN-DOULET, MD       Sandrine.thouvenin@chu-st-etienne.fr   
University Hospital of Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Catherine PAILLARD, MD       Catherine-paillard@chru-strasbourg.fr   
University Hospital of Toulouse Recruiting
Toulouse, France, 31059
Contact: Geneviève PLAT, MD       plat.g@chu-toulouse.fr   
University Hospital of Tours Recruiting
Tours, France, 37000
Contact: Pascale BLOUIN, MD       p.blouin@chu-tours.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Isabelle PELLIER, PU-PH UNIVERSITY HOSPITAL OF ANGERS

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02618109     History of Changes
Other Study ID Numbers: 2015-A00621-48
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

Keywords provided by University Hospital, Angers:
B acute lymphoblastic leukemia
leukemia relapse
pediatric onco-hematology

Additional relevant MeSH terms:
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Immunologic Factors
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Recurrence
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Physiological Effects of Drugs