Study Stopped
recruitment difficulties
Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia
LABMI
1 other identifier
interventional
119
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2016
Longer than P75 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2015
CompletedFirst Posted
Study publicly available on registry
December 1, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedOctober 3, 2022
September 1, 2022
6.7 years
April 15, 2015
September 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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 Outcomes (4)
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.
At the time of the inclusion.
Measure of percentage of TCD4+ naive and memory cells and TCD8+ naive and memory cells by FACS.
At the time of the inclusion.
Measure of percentage of gamma delta and alpha-bêta TCR CD3+ T cells by FACS.
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.
At the time of the inclusion.
Study Arms (2)
Relapse Group
OTHER* 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.
Control Group
OTHER* 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University Hospital of Amiens
Amiens, 80054, France
University Hospital of Angers
Angers, 49933, France
University Hospital of Besancon
Besançon, 25030, France
University Hospital of Bordeaux
Bordeaux, 33000, France
University Hospital of Caen
Caen, 14033, France
Civil Hospices of Lyon
Lyon, 69008, France
University Hospital of Marseille
Marseille, 13385, France
University Hospital of Nancy
Nancy, 54511, France
University Hospital of Nantes
Nantes, 44000, France
University Hospital of Nice
Nice, 06202, France
University Hospital of Trousseau (Paris)
Paris, 75571, France
University Hospital of Robert Debre (Paris)
Paris, 75935, France
University Hospital of Reims
Reims, 51092, France
University Hospital of Rennes
Rennes, 35203, France
University Hospital of Saint Etienne
Saint-Etienne, 42055, France
University Hospital of Strasbourg
Strasbourg, 67098, France
University Hospital of Toulouse
Toulouse, 31059, France
University Hospital of Tours
Tours, 37000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabelle PELLIER, PU-PH
UNIVERSITY HOSPITAL OF ANGERS
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2015
First Posted
December 1, 2015
Study Start
January 1, 2016
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
October 3, 2022
Record last verified: 2022-09