Allogeneic Hematopoietic Stem Cell Transplantation for Hematological MalignanciesREG-AlloNCT02194868
Immunoregulatory T Lymphocytes Subtypes and Haematopoietic Stem Cell Transplantation (HSCT)
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to confirm that invariant NKT lymphocytes (iNKT) reconstitution in recipient and in the graft content can predict the outcome of human allogeneic HSCT and to set up an algorithm for clinical practice that would allow the prediction of acute GVHD risk according to the quantity and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies
- What is being tested?
- Recipients and Donors
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2016to 18 Jan 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The eligible patients will be select by the responsible physicians from clinical teams involved in this study at their BMT staff. These physicians will propose the study to selected patients and provide the informed consent. Grafts and blood from donors of patients involved in this study will be provided by the different cell therapy departments related to the clinical groups. Peripheral blood from healthy donors will be obtained from volunteer donations to the "Etablissement Français du Sang" (EFS).
Who may be able to join
- Criteria for adults:
- Allogeneic HSCT with peripheral blood stem cell (PBSC) graft
- Patients transplanted in cytologic Complete Remission (CR)
- HLA 10/10 on HLA A, B, Cw, DRB1 and DQ molecules, from an intrafamilial or an unrelated donor
- - Fludarabine-ivBusulfan-ATG based reduced intensity/toxicity conditioning. Iv Busulfan doses between 6.4 mg/kg to 9.6 mg/kg or Fludarabine - TBI ≤ 8 Gy are accepted. ATG should be thymoglobuline at 5 mg/kg
- Consent form signed by the patient
Show all 14Show fewer
- Consent form signed by the donor
- Affiliated or beneficiary of a health insurance regimen
- Criteria for pediatric patients:
- Allogeneic HSCT with bone marrow grafts
- Myeloablative conditioning (either TBI 12 Gy with Cyclophosphamide or iv Busulfan (12.8 mg/kg) and cyclophosphamide or Fludarabine - TBI > 8 Gy)- HLA 10/10 on HLA A, B, Cw, DRB1 and DQ molecules, from an intrafamilial or an unrelated donor
- Consent form signed by the parents
- Consent form signed by the donor or his legal representative if it is minor
- Beneficiary of a health insurance regimen
Who cannot join
- History of previous autologous or allogeneic haematopoietic stem cell transplantation
- Disease non in cytologic CR at transplant
- Other type of conditioning than Fludarabine-ivBusulfan-ATG based reduced intensity/toxicity.
- Donor graft with any HLA mismatch including haploidentical and cord blood grafts
- Graft having one or more mismatch with the recipient HLA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role and Interactions Between Immunoregulatory T Lymphocytes Subtypes After Allogeneic Haematopoietic Stem Cell Transplantation (HSCT): Identification of New Partners Implicated on the Development of GVT (Graft Versus Tumor) and Anti-infectious Responses Without GVHD (Graft Versus Host Disease)
The purpose of this study is to confirm that invariant NKT lymphocytes (iNKT) reconstitution in recipient and in the graft content can predict the outcome of human allogeneic HSCT and to set up an algorithm for clinical practice that would allow the prediction of acute GVHD risk according to the quantity and functionality
Read the detailed description
Allogeneic hematopoietic stem cell transplantation (HSCT) remains the only curative treatment in most haematological malignancies. However, its anti-tumor effect (GVT) is often associated with the development of a graft versus host disease (GVHD) and impaired immune anti-infectious responses. The predictive and protective features of iNKT cells on the development of acute GVHD (aGVHD) are not or poorly known in humans and their mechanisms of action, in particular their potential interactions with the other regulatory effectors and immune actors of the allogeneic response, remain to be explored.
Our project aims, first, to show that the post-transplant reconstitution and/or the content of the graft in some immunoregulatory T lymphocytes can early predict the post-transplant clinical outcome and, second, to explore the underlying immunological mechanisms. For that, we propose to analyse, in homogeneous cohorts of allografted patients and their donors, the levels of iNKT cells and other cell populations implicated in the allogeneic immune response (Tregs, mucosa-associated invariant T (MAIT) cells, delta gammaT and anti-viral specific T cells) and correlate the results to the post-transplant outcome (GVHD, infections, relapse, survival). This study will be performed in a cohort of 80 adult allografted patients in four transplant departments in Paris (hospitals of Necker, Saint Antoine, Saint Louis and La Pitié Salpétrière) and in a cohort of 60 allografted paediatric patients (Robert Debré hospital in Paris). Sequential blood samples of patients will be drawn to monitor the immune reconstitution of the different lymphocyte populations of interest by flow cytometry and perform functional studies on iNKT (ex vivo expansion capacities and cytokine production). These analyses will be also performed in the corresponding donors from blood samples collected before the collection process and from the grafts (obtained by the cell therapy departments of Necker, La Pitié Salpétrière and Saint Louis hospitals). In addition, we plan to analyse the effect of, and the mechanisms by which, human cluster of differentiation 4 (CD4) CD4- and CD4+ iNKT cells might control the allogeneic response in vitro, particularly via their potential interactions with dendritic cells and Tregs. According to the results of the mechanistic studies, we will test the effect of human subtypes of iNKT cells on the GVH/GVL affects in a preclinical humanized mouse model of allogeneic HSCT.
The clinical and biological data will be anonymously entered in the electronic case report by the investigators up to 3 years post transplant.
- Being tested
- Recipients, Donors
- Keywords
- Allogeneic hematopoietic stem cell transplantation,, Immunoregulatory T lymphocytes,, acute graft versus host disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecipientsBiological
- Adult recipient:
- collected 20 ml pre-transplant
- collected 30 ml for adults on day 20 post-transplant at engraftment for cell phenotype,
- collected 30 ml on days 30, 60, 90, 180, 360 days post-HSCT for cell phenotyping at all time points, functional INKT at day 60 or 90 depending on the number of cells collected and anti-viral ELISPOT studies on days 180 and 360
- Children recipients
- collected residual blood pre-transplant
- collected residual blood on day 20 post-transplant at engraftment for cell phenotype,
- collected residual blood on days 20, 30, 90, 180 and 360 post-HSCT
DonorsBiological
- Adult donors :
- collected 20 ml of blood, (if possible before granulocyte colony-stimulating factor (GCSF) administration)
- collected 1 ml of the stem cell graft for adult recipient or 2 ml of bone marrow for children recipients These samples will be collected at the same time of those needed for transplant.
- Children donors samples
- collected residual blood
- 2ml of bone marrow (bottom of tube)
| Study group | Role | What they receive |
|---|---|---|
| donors of hematopoietic stem | Adult and minor donors of hematopoietic stem | |
| patients requiring allogeneic hema | Adult and minor patients (recipients) requiring allogeneic hema Receives: Biological: Recipients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of aGVHD
Patients' clinical files
Measured: until 3 years post graft
Secondary outcomes (1)
iNKT and effectors of the immune allogeneic response
Correlation between iNKT and regulatory effectors of the immune allogeneic response (Assessed by multiparametric flow cytometry of blood sample)
Measured: until 3 years post graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study start2 Feb 2016
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell Transplantation for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie-Thérèse Rubio, MD, PhD, Principal investigator, Central Hospital, Nancy, FranceOlivier Hermine, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194868
- Sponsor's protocol ID
- NI 12036
- Acronym
- REG-Allo
- Status last verified
- Oct 2025
- First submitted
- 17 Jul 2014
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role and Interactions Between Immunoregulatory T Lymphocytes Subtypes After Allogeneic Haematopoietic Stem Cell Transplantation (HSCT): Identification of New Partners Implicated on the Development of GVT (Graft Versus Tumor) and Anti-infectious Responses Without GVHD (Graft Versus Host Disease)
- ClinicalTrials.gov ID
- NCT02194868
- Acronym / sponsor ID
- REG-Allo / NI 12036
- Keywords
- Allogeneic hematopoietic stem cell transplantation,, Immunoregulatory T lymphocytes,, acute graft versus host disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 18 Jul 2014 (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.
The purpose of this study is to confirm that invariant NKT lymphocytes (iNKT) reconstitution in recipient and in the graft content can predict the outcome of human allogeneic HSCT and to set up an algorithm for clinical practice that would allow the prediction of acute GVHD risk according to the quantity and functionality
Detailed description
Allogeneic hematopoietic stem cell transplantation (HSCT) remains the only curative treatment in most haematological malignancies. However, its anti-tumor effect (GVT) is often associated with the development of a graft versus host disease (GVHD) and impaired immune anti-infectious responses. The predictive and protective features of iNKT cells on the development of acute GVHD (aGVHD) are not or poorly known in humans and their mechanisms of action, in particular their potential interactions with the other regulatory effectors and immune actors of the allogeneic response, remain to be explored.
Our project aims, first, to show that the post-transplant reconstitution and/or the content of the graft in some immunoregulatory T lymphocytes can early predict the post-transplant clinical outcome and, second, to explore the underlying immunological mechanisms. For that, we propose to analyse, in homogeneous cohorts of allografted patients and their donors, the levels of iNKT cells and other cell populations implicated in the allogeneic immune response (Tregs, mucosa-associated invariant T (MAIT) cells, delta gammaT and anti-viral specific T cells) and correlate the results to the post-transplant outcome (GVHD, infections, relapse, survival). This study will be performed in a cohort of 80 adult allografted patients in four transplant departments in Paris (hospitals of Necker, Saint Antoine, Saint Louis and La Pitié Salpétrière) and in a cohort of 60 allografted paediatric patients (Robert Debré hospital in Paris). Sequential blood samples of patients will be drawn to monitor the immune reconstitution of the different lymphocyte populations of interest by flow cytometry and perform functional studies on iNKT (ex vivo expansion capacities and cytokine production). These analyses will be also performed in the corresponding donors from blood samples collected before the collection process and from the grafts (obtained by the cell therapy departments of Necker, La Pitié Salpétrière and Saint Louis hospitals). In addition, we plan to analyse the effect of, and the mechanisms by which, human cluster of differentiation 4 (CD4) CD4- and CD4+ iNKT cells might control the allogeneic response in vitro, particularly via their potential interactions with dendritic cells and Tregs. According to the results of the mechanistic studies, we will test the effect of human subtypes of iNKT cells on the GVH/GVL affects in a preclinical humanized mouse model of allogeneic HSCT.
The clinical and biological data will be anonymously entered in the electronic case report by the investigators up to 3 years post transplant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| donors of hematopoietic stem | – | –Adult and minor donors of hematopoietic stem |
| patients requiring allogeneic hema | – | Biological: RecipientsAdult and minor patients (recipients) requiring allogeneic hema |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The eligible patients will be select by the responsible physicians from clinical teams involved in this study at their BMT staff. These physicians will propose the study to selected patients and provide the informed consent. Grafts and blood from donors of patients involved in this study will be provided by the different cell therapy departments related to the clinical groups. Peripheral blood from healthy donors will be obtained from volunteer donations to the "Etablissement Français du Sang" (EFS).
Key inclusion criteria (14 listed)
- Criteria for adults:
- Criteria for pediatric patients:
Key exclusion criteria (5 listed)
- History of previous autologous or allogeneic haematopoietic stem cell transplantation
- Disease non in cytologic CR at transplant
- Other type of conditioning than Fludarabine-ivBusulfan-ATG based reduced intensity/toxicity.
- Donor graft with any HLA mismatch including haploidentical and cord blood grafts
- Graft having one or more mismatch with the recipient HLA
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 |
|---|---|---|
| Recipients1. Adult recipient: * collected 20 ml pre-transplant * collected 30 ml for adults on day 20 post-transplant at engraftment for cell phenotype, * collected 30 ml on days 30, 60, 90, 180, 360 days post-HSCT for cell phenotyping at all time points, functional INKT at day 60 or 90 depending on the number of cells collected and anti-viral ELISPOT studies on days 180 and 360 2. Children recipients * collected residual blood pre-transplant * collected residual blood on day 20 post-transplant at engraftment for cell phenotype, * collected residual blood on days 20, 30, 90, 180 and 360 post-HSCT | Biological | patients requiring allogeneic hema |
| Donors1. Adult donors : * collected 20 ml of blood, (if possible before granulocyte colony-stimulating factor (GCSF) administration) * collected 1 ml of the stem cell graft for adult recipient or 2 ml of bone marrow for children recipients These samples will be collected at the same time of those needed for transplant. 2. Children donors samples * collected residual blood * 2ml of bone marrow (bottom of tube) | Biological | – |
Primary outcome
Occurrence of aGVHD
Time frame: until 3 years post graft
Patients' clinical files
1 secondary outcome
iNKT and effectors of the immune allogeneic response
Time frame: until 3 years post graft
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 20 Nov 2025.
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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.
Marie-Thérèse Rubio, MD, PhD principal investigator
Central Hospital, Nancy, France
Olivier Hermine, MD, PhD study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies, run by Assistance Publique - Hôpitaux de Paris 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 14 inclusion and 5 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 20 Nov 2025. 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?
Occurrence of aGVHD (time frame: until 3 years post graft). 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 20 Nov 2025.