Immunomonitoring After Hematopoietic Stem Cell Transplantation

NCT04635397 | Active Not Recruiting

• 2 other identifiers: 20-AOI-052020-A02138-31
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Allogeneic hematopoietic stem cell transplantation (HSCT) remains the only curative option for many hematologic malignancies, in particular acute leukemias and myelodysplastic syndromes. At the center of these reactions are the donor's T and NK cells. Several studies have highlighted the impact of T cells reconstitution on post-transplant infection rates, relapse and GvHD. Most of the post-allogeneic immune reconstitution studies available to us today include young patients (\<60 years of age) who have had genoidentic or phenoidentic 10/10 allografts and mostly only study the phenotype of a limited number of immune cells. While it is important to know the absolute number reconstitution kinetics of the different categories of immune cells, it is essential to also be able to assess the function of the different cells. Knowledge of the restoration of T function at key dates after allogeneic stem cell transplantation would make it possible to adapt post allogeneic immunomodulation (immunosuppressive treatment and injections of donor lymphocytes) and anti-infectious prophylaxis for patients. The measurement of cytokine profiles after nonspecific stimulation of T and NK lymphocytes recently made available to the immunology laboratory of the CHU de Nice allows a routine assessment of T lymphocyte function (Th1, Th2 Th 17 and T regulatory) and NK by measurement of the secretion of different cytokines after stimulation of the patient's lymphocytes with different antigens (anti-CD3 and anti-TLR7). The cytokine profile during immune reconstitution in hematopoietic cell transplants has never been evaluated; we will analyze it with regard to clinical data: relapse, infections and GVHD.

Conditions

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (5)

• Qualitative and quantitative evaluation of T and NK lymphocyte reconstitution in post allogeneic transplant

  measuring cytokine profiles (Th1, Th2 or Th17) after non-specific stimulation of T and NK lymphocytes

  on day 2 post transplant,

• Qualitative and quantitative evaluation of T and NK lymphocyte reconstitution in post allogeneic transplant

  measuring cytokine profiles (Th1, Th2 or Th17) after non-specific stimulation of T and NK lymphocytes

  90 days post transplant,

• Qualitative and quantitative evaluation of T and NK lymphocyte reconstitution in post allogeneic transplant by measuring cytokine profiles (Th1, Th2 or Th17) after non-specific stimulation of T and NK lymphocytes

  measuring cytokine profiles (Th1, Th2 or Th17) after non-specific stimulation of T and NK lymphocytes

  6 months

• Qualitative and quantitative evaluation of T and NK lymphocyte reconstitution in post allogeneic transplant

  measuring cytokine profiles (Th1, Th2 or Th17) after non-specific stimulation of T and NK lymphocytes

  one year after allogeneic transplantation

• Qualitative and quantitative evaluation of T and NK lymphocyte reconstitution in post allogeneic transplant

  measuring cytokine profiles (Th1, Th2 or Th17) after non-specific stimulation of T and NK lymphocytes

  in the event of a proven relapse or occurrence of acute grade 2 or more GVHD

Secondary Outcomes (13)

• Overal

  at Day 90 post allograft

• relapse-free survival

  at Day 90 post allograft

• Overall

  Month 6 post allograft,

• relapse-free survival

  Month 6 post allograft,

• Overall

  Month 12 post allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving an allogeneic stem cell transplantation for an hematological malignancy

You may qualify if:

• Patient over 18 years old
• Suffering from a malignant hemopathy
• Allogeneic bone marrow or hematopoietic stem cells
• Identical geno-, pheno- and haplo donors
• Informed consent signed by the patient or the person of trust in case of impossibility (deferred consent of the patient when his condition allows it)
• Affiliated with a social security scheme

You may not qualify if:

• Patient with a clinical or biological contraindication to performing an allogeneic transplant
• Patient with progressive solid cancer or in remission for less than 3 years
• HIV-positive patients
• Patients with chronic active hepatitis B or C
• Allogeneic cord blood transplant
• Allograft with sequential conditioning
• Post-allograft preemptive treatment other than injections of donor lymphocytes Withdrawal of informed consent
• Inability to undergo medical monitoring of the study for geographical, social or psychological reasons
• Minor patient
• Pregnant woman
• Patient with congenital or previously acquired immune deficiency
• Patient on prior immunosuppressive treatment
• Patient under guardianship or guardianship or placed in detention

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, CHU de NICE, 06003, France

Location

Study Design

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

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 19, 2020
• Study Start: February 3, 2021
• Primary Completion: February 2, 2024
• Study Completion (Estimated): August 18, 2026
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)