Transplant T CD4+ CCR7+ In Hematopoietic Stem Cells Allograft

NCT03280290 | Completed

• 2 other identifiers: 2010_092010-A01231-38
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a preclinical study prior to the establishment of a cell therapy protocol applicable to humans. The main objective is to evaluate the decrease in alloreactivity of TCD4 + population by partial selective depletion of CD4 + CCR7 + graft to less than 50 % of CD4 + totals. To test the alloreactivity of donor T lymphocytes.

Conditions

Acute Myeloblastic Leukemia

Keywords

Lymphocytes CD4; Lymphocytes CCR7; ALLOGRAFT; Hematopoietic Stem Cells

Outcome Measures

Primary Outcomes (2)

• Change the lymphocyte proliferation will be evaluated using a scintillation spectrometer

  Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.

  1 day, 5 day ,8 day

• Change the functional properties of cells will be evaluated by T-SPOT TB®.

  Decrease in alloreactivity of TCD4.(composite) Decrease population by partial selective depletion of CD4 + CCR7 + graft to less than 50% of total CD4 +will be evaluated on this basis criteria.

  1 day, 5 day ,8 day

Secondary Outcomes (2)

• Response to anti-infectious immunity

  24 months

• Response to anti-tumor immunity

  24 months

Study Arms (2)

receivers

EXPERIMENTAL

* Eligible for allo-HSCs from peripheral blood stem cells from a compatible donor HLA family (Appendix 1, the pre-transplant assessment must be enabled) * In a complete remission rate of leucocytes with ≥ 2G / L * Affiliated to social security person or beneficiary of such a scheme.

Biological: blood

Donors

EXPERIMENTAL

* Member of the siblings and HLA-matched A, B, Cw, DR, DQ * Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled) * Having a rate of circulating lymphocytes ≥ 1 G / L * Having a proportion of CD4 + CCR7 + ≥ 80% of the total CD4 T population * The statutes CMV and EBV are known (positive or negative). * Affiliated to social security person or beneficiary

Biological: blood

Interventions

blood BIOLOGICAL

assessment pre-donation of hematopoietic stem cells (blood sample)

Donors; receivers

Eligibility Criteria

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

You may qualify if:

• Man or woman aged 18-65 years
• Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
• In a complete remission rate of leucocytes with ≥ 2G / L
• Affiliated to social security person or beneficiary of such a scheme.
• Having signed informed consent
• Man or woman aged 18-65 years
• Achieved a hyperleucocytic acute myelogenous leukemia ( leukocytes ≥ 20G / L)
• Patients whose blasts at diagnosis were cryopreserved in the tumor bank of the University Hospital of Lille (Professor Claude Prudhomme )
• Eligible for allo - HSCs from peripheral blood stem cells from a compatible donor HLA family (Annex 3 , the pre- transplant assessment must be enabled)
• In a complete remission rate of leucocytes with ≥ 2G / L
• Affiliated to social security person or beneficiary of such a scheme.
• Having signed informed consent receivers
• Man or woman aged 18-65 years
• Member of the HLA-matched siblings and A, B, Cw, DR, DQ
• Eligible to donate peripheral blood stem cells for allo-HSCs (Appendix 2, pre donation assessment must be enabled)

You may not qualify if:

• Private person of liberty by judicial or administrative decision
• Person subject to a measure of legal protection
• Pregnant or breastfeeding woman
• People do not understand French or understanding with a disability.
• Major Protected Person in emergency and refusing or unable to give informed consent At any time, individuals may request to be removed from the study Each subject may come out of the study by decision of the competent administrative authority of the promoter and the coordinating investigator but also by decision of a co-investigator or by decision of the interested himself in accordance with regulations and as mentioned in the form of obtaining consent.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Diseases of Blood Service HURIEZ hospital CHRU de LILLE

Lille, 59037, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• YAKOUB-AGHA IBRAHIM, Professor

  CHRU de Lille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: September 12, 2017
• Study Start: March 20, 2012
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)