Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation

NCT ID: NCT03965429

Last Updated: 2025-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1020 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-14

Study Completion Date

2029-05-31

Brief Summary

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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

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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

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Malignant Hemopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Donor

In the case of a transplant from an intrafamily donor (genoid or haploid), we will also collect blood samples from the donor.

Blood samples (additional tubes from care) at inclusion

Intervention Type OTHER

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.

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

Blood samples (additional tubes from care) longitudinal

Intervention Type OTHER

Some sampling times will be systematic, while others will only be performed in the presence of specific post-transplant clinical events (eg relapse, GVH ...).

Interventions

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Blood samples (additional tubes from care) longitudinal

Some sampling times will be systematic, while others will only be performed in the presence of specific post-transplant clinical events (eg relapse, GVH ...).

Intervention Type OTHER

Blood samples (additional tubes from care) at inclusion

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Allogeneic hematopoietic stem cell transplant for hematological malignancy
2. Patients 18 years of age or older
3. Signed consent to participation
4. Membership in a social security scheme, or beneficiary of such a scheme.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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INSERM-U1068

UNKNOWN

Sponsor Role collaborator

Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raynier Devillier, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Institut Paoli-Calmettes

Marseille, Bouches-du Rhône, France

Site Status

Countries

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France

Other Identifiers

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2019-000814-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SIA-CSH-IPC 2015-017

Identifier Type: -

Identifier Source: org_study_id

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