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

May 28, 2019 updated by: Institut Paoli-Calmettes
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1020

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Bouches-du Rhône
      • Marseille, Bouches-du Rhône, France, 13009
        • Recruiting
        • Institut Paoli-Calmettes
        • Principal Investigator:
          • Raynier DEVILLIER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population is male and / or female over 18 years of age with hematologic malignancies receiving allogeneic hematopoietic stem cell transplantation and corresponding donors.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Donor
In the case of a transplant from an intrafamily donor (genoid or haploid), we will also collect blood samples from the donor.
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.
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
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 ...).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years after HSC transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Collaborators

INSERM-U1068

Investigators

  • Principal Investigator: Raynier Devillier, MD, PhD, Institut Paoli-Calmettes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2019

Primary Completion (Anticipated)

May 14, 2029

Study Completion (Anticipated)

May 31, 2029

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 28, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 28, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SIA-CSH-IPC 2015-017
  • 2019-000814-13 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malignant Hemopathy

Clinical Trials on Blood samples (additional tubes from care) at inclusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe