Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation

Malignant Hemopathy Clinical Trial

— SIA-CSH  

Official title:

Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03965429
• Other study ID #: SIA-CSH-IPC 2015-017
• Secondary ID: 2019-000814-13
• Status: Recruiting
• Start date: May 14, 2019
• Est. completion date: May 31, 2029

Study information

• Verified date: May 2019
• Source: Institut Paoli-Calmettes
• Contact: Dominique Genre, MD
• Phone: 0491223778
• Email: drci.up[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1020
• Est. completion date: May 31, 2029
• Est. primary completion date: May 14, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Malignant Hemopathy

Intervention

Other:
• 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 ...).
• 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.

Locations

Country	Name	City	State
France	Institut Paoli-Calmettes	Marseille	Bouches-du Rhône

Sponsors (2)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes	INSERM-U1068

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 years after HSC transplantation