Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation

Active, not recruiting

• Conditions: Malignant Hemopathy
• Interventions: Other: Blood samples (additional tubes from care) longitudinal; Other: Blood samples (additional tubes from care) at inclusion

• Registration Number: NCT03965429
• Lead Sponsor: Institut Paoli-Calmettes

Brief 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.

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 Timeline

• Study Start: 2019-05-14
• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-03
• Last Update Posted: 2024-10-04
• Primary Completion: 2029-05-14
• Study Completion: 2029-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1020

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Receiver	Blood samples (additional tubes from care) longitudinal	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
Donor	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.

Primary Outcome Measures

Name	Time	Method
Evolution of the immune blood populations in patients who have received allogeneic hematopoietic stem cell transplantation.	5 years after HSC transplantation	longitudinal study of the immune subpopulations of allografted patients for hematological malignancies.

Trial Locations

Locations (1)

Institut Paoli-Calmettes; 🇫🇷 Marseille, Bouches-du Rhône, France