Status:
RECRUITING
Allogeneic Immunotherapy for Hematological Malignancies by Selective Depletion of Regulatory T Cells
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Hematological Malignancies
Regulatory T Cell Depletion
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The investigators have previously shown the absence of toxicity of Treg-depleted-DLI and the possibility to triggering alloreactivity (GVHD/GVT) in relapsing patients dealing with hematological malign...
Detailed Description
This clinical trial is designed to demonstrate the benefit of Treg-depleted DLI as compared to the reference treatment of relapse in hematological malignancies after allogeneic HSCT which is currently...
Eligibility Criteria
Inclusion
- Children and adults regardless of age or weight allograft for primary or secondary acute leukemia, MDS, lympho-proliferative syndrome (CLL, Myeloma, Lymphoma) or myelo-proliferative syndrome.
- Prior allogeneic HSCT (myeloablative or non-myeloablative conditioning) from a family donor geno-identical HLA or a volunteer donor HLA 10/10 or 9/10.
- Molecular, cytogenetic, cytological relapse regardless of the date after the transplant.
- Previous standard DLI should have brought a total dose of at least 5.10\^6 CD3 + / kg (donor HLA-geno idendique) or 2.10\^6 CD3 + / kg (voluntary donor) or 5.10\^5 CD3+/kg (donor haplo-idendique).
- Patient corresponding to the failure criteria of a previous standard DLI, defined for each type of hematological malignancies in the test model "DLI-Treg-1" after a delay of at least 30 days in the case of a progressive disease after DLI and at least 60 days in the case of stable disease (due to possible delayed responses after DLI).
- Patient consented to the study (the consent of both parents will be collected for minors)
- Patients insured by a social security system.
- Negative pregnancy test (β-HCG hormone) within the 7 days prior to enrollment
Exclusion
- Presence of acute GVHD grade\> II or extensive chronic GVHD since the first DLI
- Patient receiving immunosuppressive therapy for the treatment of GVHD or other reason
- Impairment of liver function (transaminases\> 5 N or bilirubin\> 50 µM except Gilbert's disease) or renal function (creatinine clearance \<30 ml / min)
- OMS performance status \> 2
- Non controlled severe infection
- Patient under tutorship, curatorship or legal protection
- Donor Inclusion Criteria
- Being the initial HSC donor (HLA geno-identical family or haplo-identique or non-family HLA 10/10 or 9/10)
- Weight ≥20 kg authorizing the lymphapheresis
- Having no contra-indications for donating blood
- Absence of severe heart failure, unstable heart disease, uncontrolled hypertension, type 1 diabetes
- Negative serology for HIV1-2, HBV, HCV, HTLV 1 and VDRL/TPHA in the 30 days prior to apheresis. Negative viral genomics diagnosis is required for HIV, HBV and HCV
- Being informed of the study, and have given an oral non opposition
Key Trial Info
Start Date :
February 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03236129
Start Date
February 22 2018
End Date
February 1 2026
Last Update
December 18 2023
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, France, 94010