Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02618109
Recruitment Status : Recruiting
First Posted : December 1, 2015
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Tracking Information
First Submitted Date  ICMJE April 15, 2015
First Posted Date  ICMJE December 1, 2015
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 26, 2015)
Measure of Treg and deficient natural killer (NK) cells in children newly diagnosed with their first relapse of B-ALL. [ Time Frame: At the time of the inclusion ]
Measure of Treg and deficient natural killer (NK) cells in children newly diagnosed with their first relapse of B-ALL. 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
  • 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. ]
  • 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. ]
  • Measure of percentage of gamma delta and alpha-bêta TCR CD3+ T cells by FACS. [ Time Frame: 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2015)
  • Measure of the proportions of T CD4+ lymphocytes (Cluster of Differentiation 4), T CD8+ lymphocytes (Cluster of Differentiation 8), and gamma delta T cells (gamma delta T-cell receptor+). [ Time Frame: At the time of the inclusion ]
    Measure of the proportions of T CD4+ lymphocytes (Cluster of Differentiation 4), T CD8+ lymphocytes (Cluster of Differentiation 8), T naïve cells and T memory cells, NK cells, NKT cells (Lymphocyte Natural killer T) and gamma delta T cells (gamma delta T-cell receptor+).
  • Measure of TRECs (T cell receptor excision circle) and naïve CD4+CD45RA+CD31+ T cells. [ Time Frame: At the time of the inclusion ]
    Measure of TRECs (T cell receptor excision circle) and naïve CD4+CD45RA+CD31+ T cells.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia
Official Title  ICMJE Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • B Acute Lymphoblastic Leukemia
  • Leukemia Relapse
Intervention  ICMJE Biological: Collection of blood samples
Collection of blood samples
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Biological: Collection of blood samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 26, 2015)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Isabelle PELLIER, PU-PH ispellier@chu-angers.fr
Contact: Elsa BERARDI elberardi@chu-angers.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02618109
Other Study ID Numbers  ICMJE 2015-A00621-48
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Angers
Study Sponsor  ICMJE University Hospital, Angers
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Isabelle PELLIER, PU-PH UNIVERSITY HOSPITAL OF ANGERS
PRS Account University Hospital, Angers
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP