NCT03965429

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,020

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
May 2019May 2029

Study Start

First participant enrolled

May 14, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2029

Expected
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

10 years

First QC Date

May 16, 2019

Last Update Submit

June 13, 2025

Conditions

Malignant Hemopathy

Keywords

malignant hemopathyallogeneic hematopoietic stem cell transplantblood collection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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

Interventions

Blood samples (additional tubes from care) longitudinalOTHER

Some sampling times will be systematic, while others will only be performed in the presence of specific post-transplant clinical events (eg relapse, GVH ...).

Receiver
Blood samples (additional tubes from care) at inclusionOTHER

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.

Donor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli-Calmettes

Marseille, Bouches-du Rhône, 13009, France

Location

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

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Raynier Devillier, MD, PhD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 29, 2019

Study Start

May 14, 2019

Primary Completion (Estimated)

May 14, 2029

Study Completion (Estimated)

May 31, 2029

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)