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

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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

Tracking Information
First Submitted Date May 16, 2019
First Posted Date May 29, 2019
Last Update Posted Date May 29, 2019
Actual Study Start Date May 14, 2019
Estimated Primary Completion Date May 14, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation
Official Title Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
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
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.
Condition 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 ...).
  • 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.

Study Groups/Cohorts
  • Donor
    In the case of a transplant from an intrafamily donor (genoid or haploid), we will also collect blood samples from the donor.
    Intervention: Other: Blood samples (additional tubes from care) at inclusion
  • 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
    Intervention: Other: Blood samples (additional tubes from care) longitudinal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 28, 2019)
1020
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2029
Estimated Primary Completion Date May 14, 2029   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Dominique Genre, MD 0491223778 drci.up@ipc.unicancer.fr
Contact: Margot Berline, MSc, MBA 0491223314 drci.up@ipc.unicancer.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03965429
Other Study ID Numbers SIA-CSH-IPC 2015-017
2019-000814-13 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Institut Paoli-Calmettes
Study Sponsor Institut Paoli-Calmettes
Collaborators INSERM-U1068
Investigators
Principal Investigator: Raynier Devillier, MD, PhD Institut Paoli-Calmettes
PRS Account Institut Paoli-Calmettes
Verification Date May 2019