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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965429
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
INSERM-U1068
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Malignant Hemopathy Other: Blood samples (additional tubes from care) longitudinal Other: Blood samples (additional tubes from care) at inclusion

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.

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Study Type : Observational
Estimated Enrollment : 1020 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : May 14, 2029
Estimated Study Completion Date : May 31, 2029

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 ...).




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965429


Contacts
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Contact: Dominique Genre, MD 0491223778 drci.up@ipc.unicancer.fr
Contact: Margot Berline, MSc, MBA 0491223314 drci.up@ipc.unicancer.fr

Locations
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France
Institut Paoli-Calmettes Recruiting
Marseille, Bouches-du Rhône, France, 13009
Contact: Dominique GENRE, MD    +33 4 91 22 37 78    drci.up@ipc.unicancer.fr   
Principal Investigator: Raynier DEVILLIER         
Sponsors and Collaborators
Institut Paoli-Calmettes
INSERM-U1068
Investigators
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Principal Investigator: Raynier Devillier, MD, PhD Institut Paoli-Calmettes
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03965429    
Other Study ID Numbers: SIA-CSH-IPC 2015-017
2019-000814-13 ( EudraCT Number )
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Paoli-Calmettes:
malignant hemopathy
allogeneic hematopoietic stem cell transplant
blood collection