Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation (SIA-CSH)

Institut Paoli-Calmettes

Status: Active, not recruiting

Conditions: Malignant Hemopathy

Treatments: Other: Blood samples (additional tubes from care) longitudinal; Other: Blood samples (additional tubes from care) at inclusion

Study type: Observational

Funder types: Other

Identifiers

NCT03965429

2019-000814-13 (EudraCT Number)

SIA-CSH-IPC 2015-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,020 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

1,020 participants in 2 patient groups

Donor

Description:

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

Treatment:

Other: Blood samples (additional tubes from care) at inclusion

Receiver

Description:

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

Treatment:

Other: Blood samples (additional tubes from care) longitudinal