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NCT Number: NCT03965429

Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Malignant Hemopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Paoli-Calmettes

Marseille, Bouches-du Rhône, 13009, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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).

Treatment and study plan

Blood samples (additional tubes from care) longitudinal

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 ...).

Blood samples (additional tubes from care) at inclusion

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Collaborators

  • INSERM-U1068

Registry information

Acronym: SIA-CSH

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
May 29, 2019
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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