Acute Myeloblastic LeukemiaCCR7-CD4-DPLNCT03280290
Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft
A study testing blood in people with Acute Myeloblastic Leukemia, run by University Hospital, Lille at 1 site in France.
Trial summary
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans. The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloblastic Leukemia
- What is being tested?
- blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2012to Apr 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria of the receiver anti -infectious immunity
- Man or woman aged 18-65 years
- Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
- In a complete remission rate of leucocytes with ≥ 2G / L
- Affiliated to social security person or beneficiary of such a scheme.
- Having signed informed consent
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- Inclusion criteria for the study of the receiver of anti tumor immunity
- Man or woman aged 18-65 years
- Achieved a hyperleucocytic acute myelogenous leukemia ( leukocytes ≥ 20G / L)
- Patients whose blasts at diagnosis were cryopreserved in the tumor bank of the University Hospital of Lille (Professor Claude Prudhomme )
- Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
- In a complete remission rate of leucocytes with ≥ 2G / L
- Affiliated to social security person or beneficiary of such a scheme.
- Having signed informed consent receivers
- Man or woman aged 18-65 years
- Member of the HLA-matched siblings and A, B, Cw, DR, DQ
- Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled)
- Having a rate of circulating lymphocytes ≥ 1 G / L
- Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population
- The statutes CMV and EBV are known (positive or negative).
- Affiliated to social security person or beneficiary of such a scheme. who signed informed consent -
Who cannot join
- Criteria for non inclusion of the pairs donor / Receiver
- Private person of liberty by judicial or administrative decision
- Person subject to a measure of legal protection
- Pregnant or breastfeeding woman
- People do not understand French or understanding with a disability.
- Major Protected Person in emergency and refusing or unable to give informed consent At any time, individuals may request to be removed from the study Each subject may come out of the study by decision of the competent administrative authority of the promoter and the coordinating investigator but also by decision of a co-investigator or by decision of the interested himself in accordance with regulations and as mentioned in the form of obtaining consent.
Trial locations and contacts
1 site in 1 country.
France1 site
Diseases of Blood Service HURIEZ hospital CHRU de LILLE
Lille, 59037
About this study
Official title: Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.
The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes.
Read the detailed description
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.
The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes , T lymphocytes CD4 + CCR7 + donor will be stimulated by mature dendritic cells (DC) derived from recipient circulating monocytes in a mixed lymphocyte reaction model sensitized ( MLDCR ) , experiencing HLA -compatibility . This first step will confirm the results previously obtained in a situation incompatible HLA .
- Conditions
- Acute Myeloblastic Leukemia
- Being tested
- blood
- Keywords
- Lymphocytes CD4, Lymphocytes CCR7, ALLOGRAFT, Hematopoietic Stem Cells
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bloodBiological
assessment pre-donation of hematopoietic stem cells (blood sample)
| Study group | Role | What they receive |
|---|---|---|
| receivers | Experimental | * Eligible for allo-HSCs from peripheral blood stem cells from a compatible donor HLA family (Appendix 1, the pre-transplant assessment must be enabled)
* In a complete remission rate of leucocytes with ≥ 2G / L
* Affiliated to social security person or beneficiary of such a scheme. Receives: Biological: blood |
| Donors | Experimental | * Member of the siblings and HLA-matched A, B, Cw, DR, DQ
* Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled)
* Having a rate of circulating lymphocytes ≥ 1 G / L
* Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population
* The statutes CMV and EBV are known (positive or negative).
* Affiliated to social security person or beneficiary Receives: Biological: blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer
Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
Measured: 1 day, 5 day ,8 day
Change the functional properties of cells will be evaluated by T-SPOT TB®.
Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
Measured: 1 day, 5 day ,8 day
Secondary outcomes (2)
Response to anti-infectious immunity
Measure the anti-infectious immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
Measured: 24 months
Response to anti-tumor immunity
Measure the anti-tumor immunity during a partial selective depletion of TCD4 + CCR7 + (≤ 50%)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start20 Mar 2012
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YAKOUB-AGHA IBRAHIM, Professor, Study director, CHRU de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280290
- Sponsor's protocol ID
- 2010_09
- Other IDs
- 2010-A01231-38
- Acronym
- CCR7-CD4-DPL
- Status last verified
- Sep 2017
- First submitted
- 24 Jun 2014
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Selective Depletion in Lymphocytes Transplant T CD4+ CCR7+ in Hematopoeitic Stem Cells Allograft
- ClinicalTrials.gov ID
- NCT03280290
- Acronym / sponsor ID
- CCR7-CD4-DPL / 2010_09
- Conditions
- Acute Myeloblastic Leukemia
- Keywords
- Lymphocytes CD4, Lymphocytes CCR7, ALLOGRAFT, Hematopoietic Stem Cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 20 Mar 2012 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 12 Sep 2017 (actual)
- 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.
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.
The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes.
Detailed description
This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans.
The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes , T lymphocytes CD4 + CCR7 + donor will be stimulated by mature dendritic cells (DC) derived from recipient circulating monocytes in a mixed lymphocyte reaction model sensitized ( MLDCR ) , experiencing HLA -compatibility . This first step will confirm the results previously obtained in a situation incompatible HLA .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| receivers | Experimental | Biological: blood* Eligible for allo-HSCs from peripheral blood stem cells from a compatible donor HLA family (Appendix 1, the pre-transplant assessment must be enabled) * In a complete remission rate of leucocytes with ≥ 2G / L * Affiliated to social security person or beneficiary of such a scheme. |
| Donors | Experimental | Biological: blood* Member of the siblings and HLA-matched A, B, Cw, DR, DQ * Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled) * Having a rate of circulating lymphocytes ≥ 1 G / L * Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population * The statutes CMV and EBV are known (positive or negative). * Affiliated to social security person or beneficiary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Inclusion criteria of the receiver anti -infectious immunity
- Man or woman aged 18-65 years
- Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
- In a complete remission rate of leucocytes with ≥ 2G / L
- Affiliated to social security person or beneficiary of such a scheme.
Key exclusion criteria (6 listed)
- Criteria for non inclusion of the pairs donor / Receiver
- Private person of liberty by judicial or administrative decision
- Person subject to a measure of legal protection
- Pregnant or breastfeeding woman
- People do not understand French or understanding with a disability.
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 |
|---|---|---|
| bloodassessment pre-donation of hematopoietic stem cells (blood sample) | Biological | Donors, receivers |
Primary outcome
Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer
Time frame: 1 day, 5 day ,8 day
Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
Change the functional properties of cells will be evaluated by T-SPOT TB®.
Time frame: 1 day, 5 day ,8 day
Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.
2 secondary outcomes
Response to anti-infectious immunity
Time frame: 24 months
Response to anti-tumor immunity
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: No
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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.
YAKOUB-AGHA IBRAHIM, Professor study director
CHRU de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood in people with Acute Myeloblastic Leukemia, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer (time frame: 1 day, 5 day ,8 day). The study lists 2 primary outcomes in all. 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 12 Sep 2017.