Allogeneic Hematopoietic Stem Cell TransplantationREAL-GREFFENCT03357172
Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation
A study testing Blood Sample, Bone marrow aspiration and Allogeneic hematopoietic stem cell sample in people with Allogeneic Hematopoietic Stem Cell Transplantation, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation
- What is being tested?
- Blood Sample, Bone marrow aspiration and Allogeneic hematopoietic stem cell sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 30 Sep 2026
- 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
- patient of the Nancy CHRU, for whom a CSH allograft is planned. or
- hematopoietic stem cell donors received at Nancy's CHRU for the duration of the research
Who cannot join
- Positive HIV
- active hepatitis B or C infection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Vandœuvre-lès-Nancy, 54511
Marie-Thérèse RUBIO, Pr, 0383153030
About this study
The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant immune reconstitution of those different cell subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary study will focus on the impact of microbiota dysbiosis on post-transplant immune response and regulatory cell subsets.
- Being tested
- Blood Sample, Bone marrow aspiration, Allogeneic hematopoietic stem cell sample
- Keywords
- Immune recovery, Immunomodulatory cells, GVHD, GVL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood SampleBiological
Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2
Bone marrow aspirationBiological
Additional bone marrow aspiration before graft, D30, D90, Y1
Blood sampleBiological
Before donation
Allogeneic hematopoietic stem cell sampleBiological
Allogeneic hematopoietic stem cell sample
| Study group | Role | What they receive |
|---|---|---|
| Recipient | Experimental | Not described Receives: Biological: Blood Sample; Biological: Bone marrow aspiration |
| Donor | Experimental | Not described Receives: Biological: Blood sample; Biological: Allogeneic hematopoietic stem cell sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of regulatory immune cells in peripheral blood.
Measured: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Secondary outcomes (5)
Occurrence of graft versus host (GVH) reaction after allografting of CSH
Measured: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Incidence of relapse
Measured: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Incidence of infections
Measured: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Progress-free survival
Measured: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Overall survival
Measured: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Oct 2019
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Allogeneic Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357172
- Sponsor's protocol ID
- 2018-A03267-48
- Acronym
- REAL-GREFFE
- Status last verified
- Oct 2019
- First submitted
- 24 Nov 2017
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Notarantonio AB, Morisset S, Piucco R, Peres M, Boulange L, Alitcher A, Brouard J, Monchablon L, Campidelli A, El Ouahabi S, Guisnel C, Moulin C, Kicki C, Roth-Guepin G, Feugier P, Bittencourt MC, Aarnink A, D'Aveni-Piney M, Hergalant S, Pagliuca S, Rubio MT. Differential Clinical and Immunological Impacts of Anti-T-Lymphocyte Globulin (ATLG) vs. Anti-Thymocyte Globulin (ATG) in Preventing Graft-Versus-Host Disease Post-Allogeneic Hematopoietic Stem Cell Transplantation: A Comparative Study. Am J Hematol. 2025 Apr;100(4):626-637. doi: 10.1002/ajh.27619. Epub 2025 Feb 4.
PubMed 39905816Notarantonio AB, Bertrand A, Piucco R, Fievet G, Sartelet H, Boulange L, de Isla N, De Carvalho Bittencourt M, Hergalant S, Rubio MT, D'Aveni M. Highly immunosuppressive myeloid cells correlate with early relapse after allogeneic stem cell transplantation. Exp Hematol Oncol. 2024 May 11;13(1):50. doi: 10.1186/s40164-024-00516-4.
PubMed 38734654
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Factors Involved in the Regulation of Immune Responses After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03357172
- Acronym / sponsor ID
- REAL-GREFFE / 2018-A03267-48
- Keywords
- Immune recovery, Immunomodulatory cells, GVHD, GVL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 29 Nov 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.
The study concerns donors and patients receiving allogeneic stem cell haematopoietic transplantation. The aim of the study is to analyse HSC graft content in immune effector T (naive, memory, activated, exhausted) and immunoregulatory cell subtypes (Tregs, iNKT, MDSC) and correlate the results with post-transplant immune reconstitution of those different cell subtypes and clinical events (graft-versus-host-disease, relapse, infections). An ancillary study will focus on the impact of microbiota dysbiosis on post-transplant immune response and regulatory cell subsets.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recipient | Experimental | Biological: Blood Sample, Biological: Bone marrow aspiration |
| Donor | Experimental | Biological: Blood sample, Biological: Allogeneic hematopoietic stem cell sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient of the Nancy CHRU, for whom a CSH allograft is planned. or
- hematopoietic stem cell donors received at Nancy's CHRU for the duration of the research
Key exclusion criteria (2 listed)
- Positive HIV
- active hepatitis B or C infection
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 |
|---|---|---|
| Blood SampleAdditional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2 | Biological | Recipient |
| Bone marrow aspirationAdditional bone marrow aspiration before graft, D30, D90, Y1 | Biological | Recipient |
| Blood sampleBefore donation | Biological | Donor |
| Allogeneic hematopoietic stem cell sampleAllogeneic hematopoietic stem cell sample | Biological | Donor |
Primary outcome
Proportions of regulatory immune cells in peripheral blood.
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
5 secondary outcomes
Occurrence of graft versus host (GVH) reaction after allografting of CSH
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Incidence of relapse
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Incidence of infections
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Progress-free survival
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Overall survival
Time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Derived from this study: PubMed 39905816Notarantonio AB, Morisset S, Piucco R, Peres M, Boulange L, Alitcher A, Brouard J, Monchablon L, Campidelli A, El Ouahabi S, Guisnel C, Moulin C, Kicki C, Roth-Guepin G, Feugier P, Bittencourt MC, Aarnink A, D'Aveni-Piney M, Hergalant S, Pagliuca S, Rubio MT. Differential Clinical and Immunological Impacts of Anti-T-Lymphocyte Globulin (ATLG) vs. Anti-Thymocyte Globulin (ATG) in Preventing Graft-Versus-Host Disease Post-Allogeneic Hematopoietic Stem Cell Transplantation: A Comparative Study. Am J Hematol. 2025 Apr;100(4):626-637. doi: 10.1002/ajh.27619. Epub 2025 Feb 4.
- Derived from this study: PubMed 38734654Notarantonio AB, Bertrand A, Piucco R, Fievet G, Sartelet H, Boulange L, de Isla N, De Carvalho Bittencourt M, Hergalant S, Rubio MT, D'Aveni M. Highly immunosuppressive myeloid cells correlate with early relapse after allogeneic stem cell transplantation. Exp Hematol Oncol. 2024 May 11;13(1):50. doi: 10.1186/s40164-024-00516-4.
- 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.
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 Sample, Bone marrow aspiration and Allogeneic hematopoietic stem cell sample in people with Allogeneic Hematopoietic Stem Cell Transplantation, run by Central Hospital, Nancy, France 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie-Thérèse RUBIO, PU-PH (0383153257 ext. +33, m.rubio@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of regulatory immune cells in peripheral blood. (time frame: After 7 days, 15 days, 21 days, 30 days, 60 days, 90 days, 180 days, 1 year, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03357172, which also lists 2 linked publications.
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 14 Oct 2019.