B Acute Lymphoblastic LeukemiaPhase 4LABMINCT02618109
Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia
A Phase 4 study testing Collection of blood samples in people with B Acute Lymphoblastic Leukemia and Leukemia Relapse, run by University Hospital, Angers at 18 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- B Acute Lymphoblastic Leukemia, Leukemia Relapse
- What is being tested?
- Collection of blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 18 sitesFrance
- Study dates
- Jan 2016to Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
- 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
- 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
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
University Hospital of Amiens
Amiens, 80054
University Hospital of Angers
Angers, 49933
University Hospital of Besancon
Besançon, 25030
University Hospital of Bordeaux
Bordeaux, 33000
University Hospital of Caen
Caen, 14033
Civil Hospices of Lyon
Lyon, 69008
University Hospital of Marseille
Marseille, 13385
University Hospital of Nancy
Nancy, 54511
University Hospital of Nantes
Nantes, 44000
University Hospital of Nice
Nice, 06202
University Hospital of Trousseau (Paris)
Paris, 75571
University Hospital of Robert Debre (Paris)
Paris, 75935
University Hospital of Reims
Reims, 51092
University Hospital of Rennes
Rennes, 35203
University Hospital of Saint Etienne
Saint-Etienne, 42055
University Hospital of Strasbourg
Strasbourg, 67098
University Hospital of Toulouse
Toulouse, 31059
University Hospital of Tours
Tours, 37000
About this study
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.
- Conditions
- B Acute Lymphoblastic Leukemia, Leukemia Relapse
- Being tested
- Collection of blood samples
- Keywords
- B acute lymphoblastic leukemia, leukemia relapse, pediatric onco-hematology
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of blood samplesBiological
Collection of blood samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Collection of blood samples |
| 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. Receives: Biological: Collection of blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the time of the inclusion.
Measure of percentage of TCD4+ naive and memory cells and TCD8+ naive and memory cells by FACS.
Measured: At the time of the inclusion.
Measure of percentage of gamma delta and alpha-bêta TCR CD3+ T cells by FACS.
Measured: 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.
Measured: At the time of the inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2022
- Study completionSep 2022
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Isabelle PELLIER, PU-PH, Principal investigator, UNIVERSITY HOSPITAL OF ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618109
- Sponsor's protocol ID
- 2015-A00621-48
- Acronym
- LABMI
- Status last verified
- Sep 2022
- First submitted
- 15 Apr 2015
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of New Immune Factors Specific of Relapse in Childhood B Lineage Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT02618109
- Acronym / sponsor ID
- LABMI / 2015-A00621-48
- Conditions
- B Acute Lymphoblastic Leukemia, Leukemia Relapse
- Keywords
- B acute lymphoblastic leukemia, leukemia relapse, pediatric onco-hematology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relapse Group | Other | Biological: Collection of blood samples* 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 | Biological: Collection of blood samples* 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of blood samplesCollection of blood samples | Biological | Control Group, Relapse Group |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle PELLIER, PU-PH principal investigator
UNIVERSITY HOSPITAL OF ANGERS
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collection of blood samples in people with B Acute Lymphoblastic Leukemia and Leukemia Relapse, run by University Hospital, Angers at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2022.