Malignant HemopathySIA-CSHNCT03965429
Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation
An observational study of Malignant Hemopathy, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Description of the evolution of the biological characteristics of immune blood populations and biomarkers of interest in patients who have received allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Hemopathy
- What is being tested?
- Blood samples (additional tubes from care) longitudinal and Blood samples (additional tubes from care) at inclusion
- How many people
- 1,020 participants
- Where
- 1 siteFrance
- Study dates
- 14 May 2019to 31 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population is male and / or female over 18 years of age with hematologic malignancies receiving allogeneic hematopoietic stem cell transplantation and corresponding donors.
Who may be able to join
- Allogeneic hematopoietic stem cell transplant for hematological malignancy
- Patients 18 years of age or older
- Signed consent to participation
- Membership in a social security scheme, or beneficiary of such a scheme.
Who cannot join
- A person of legal age subject to a legal protection measure (major under guardianship, curatorship or court bail), or unable to express consent (language criteria included).
Trial locations and contacts
1 site in 1 country.
About this study
Description of the evolution of the biological characteristics of immune blood populations and biomarkers of interest in patients who have received allogeneic hematopoietic stem cell transplantation.
Read the detailed description
a more in-depth analysis of the different immune cell sub-populations as well as serum markers (cytokines) would provide a better understanding of post-allograft immune reconstitution mechanisms and identify potential immunologic biomarkers predictive of GVH or relapse.
- Conditions
- Malignant Hemopathy
- Being tested
- Blood samples (additional tubes from care) longitudinal, Blood samples (additional tubes from care) at inclusion
- Keywords
- malignant hemopathy, allogeneic hematopoietic stem cell transplant, blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples (additional tubes from care) longitudinalOther
Some sampling times will be systematic, while others will only be performed in the presence of specific post-transplant clinical events (eg relapse, GVH ...).
Blood samples (additional tubes from care) at inclusionOther
In the case of a transplant from an intrafamily donor (genoid or haploid), we will also collect blood samples from the donor. A single blood sample of 28 mL (7 EDTA tubes) will be made.
In order not to represent an additional sample for the donor, this sample will be taken before the mobilization of the hematopoietic stem cells, during the biological assessment required for the biological donation qualification.
| Study group | Role | What they receive |
|---|---|---|
| Donor | In the case of a transplant from an intrafamily donor (genoid or haploid), we will also collect blood samples from the donor. Receives: Other: Blood samples (additional tubes from care) at inclusion | |
| Receiver | Systematic longitudinal collection of blood samples for any patient receiving an allogeneic CSH transplant in our facility, regardless of donor category selected and type of graft used Receives: Other: Blood samples (additional tubes from care) longitudinal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the immune blood populations in patients who have received allogeneic hematopoietic stem cell transplantation.
longitudinal study of the immune subpopulations of allografted patients for hematological malignancies.
Measured: 5 years after HSC transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start14 May 2019
- Primary completion14 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant HemopathyStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- 1,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM-U1068
- Responsible party
- Sponsor
- Investigators
- Raynier Devillier, MD, PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965429
- Sponsor's protocol ID
- SIA-CSH-IPC 2015-017
- Other IDs
- 2019-000814-13, 2019
- Acronym
- SIA-CSH
- Status last verified
- Sep 2026
- First submitted
- 16 May 2019
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03965429
- Acronym / sponsor ID
- SIA-CSH / SIA-CSH-IPC 2015-017
- Conditions
- Malignant Hemopathy
- Keywords
- malignant hemopathy, allogeneic hematopoietic stem cell transplant, blood collection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,020 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Collaborators
- INSERM-U1068
- Study start
- 14 May 2019 (actual)
- Primary completion
- 14 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 29 May 2019 (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.
Description of the evolution of the biological characteristics of immune blood populations and biomarkers of interest in patients who have received allogeneic hematopoietic stem cell transplantation.
Detailed description
a more in-depth analysis of the different immune cell sub-populations as well as serum markers (cytokines) would provide a better understanding of post-allograft immune reconstitution mechanisms and identify potential immunologic biomarkers predictive of GVH or relapse.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donor | – | Other: Blood samples (additional tubes from care) at inclusionIn the case of a transplant from an intrafamily donor (genoid or haploid), we will also collect blood samples from the donor. |
| Receiver | – | Other: Blood samples (additional tubes from care) longitudinalSystematic longitudinal collection of blood samples for any patient receiving an allogeneic CSH transplant in our facility, regardless of donor category selected and type of graft used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is male and / or female over 18 years of age with hematologic malignancies receiving allogeneic hematopoietic stem cell transplantation and corresponding donors.
Key inclusion criteria (4 listed)
- Allogeneic hematopoietic stem cell transplant for hematological malignancy
- Patients 18 years of age or older
- Signed consent to participation
- Membership in a social security scheme, or beneficiary of such a scheme.
Key exclusion criteria (1 listed)
- A person of legal age subject to a legal protection measure (major under guardianship, curatorship or court bail), or unable to express consent (language criteria included).
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 samples (additional tubes from care) longitudinalSome sampling times will be systematic, while others will only be performed in the presence of specific post-transplant clinical events (eg relapse, GVH ...). | Other | Receiver |
| Blood samples (additional tubes from care) at inclusionIn the case of a transplant from an intrafamily donor (genoid or haploid), we will also collect blood samples from the donor. A single blood sample of 28 mL (7 EDTA tubes) will be made. In order not to represent an additional sample for the donor, this sample will be taken before the mobilization of the hematopoietic stem cells, during the biological assessment required for the biological donation qualification. | Other | Donor |
Primary outcome
Evolution of the immune blood populations in patients who have received allogeneic hematopoietic stem cell transplantation.
Time frame: 5 years after HSC transplantation
longitudinal study of the immune subpopulations of allografted patients for hematological malignancies.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- 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.
Raynier Devillier, MD, PhD principal investigator
Institut Paoli-Calmettes
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 Malignant Hemopathy, run by Institut Paoli-Calmettes 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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Evolution of the immune blood populations in patients who have received allogeneic hematopoietic stem cell transplantation. (time frame: 5 years after HSC transplantation). 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 1 Oct 2026.