Allogeneic Immunotherapy for Hematological Malignancies by Selective Depletion of Regulatory T Cells
NCT ID: NCT03236129
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
52 participants
INTERVENTIONAL
2018-02-22
2026-02-28
Brief Summary
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The Investigators, we plan 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 based on standard DLI
Detailed Description
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Patients who have never shown any signs of GVHD and for which one (or more) unmanipulated DLI have been ineffective. Those patients will receive a subsequent DLI, which will be either unmanipulated (control arm) or Treg depleted (experimental arm) after a randomization. In both cases, the second DLI will be immediately preceded by a lymphodepleting treatment based on cyclophosphamide and fludarabine association.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treg depleted DLI
Patients will receive a lymphodepleting treatment combining cyclophosphamide and fludarabine followed by Treg depleted (Donor Lymphocytes Infusion (DLI)
T-reg depleted DLI
The patients in the experimental arm benefit of a DLI depleted from regulatory T lymphocytes
Unmanipulated DLI
Patients will receive a lymphodepleting treatment combining cyclophosphamide and fludarabine followed by a standard DLI (unmanipulated)
Standard DLI
The patients in this arm benefit of a standard DLI.
Interventions
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T-reg depleted DLI
The patients in the experimental arm benefit of a DLI depleted from regulatory T lymphocytes
Standard DLI
The patients in this arm benefit of a standard DLI.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Florence BEKCERICH, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Henri Mondor Hospital
Créteil, , France
Countries
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Central Contacts
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Facility Contacts
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Damien VANHOYE, PhD
Role: primary
Laetitia GREGOIRE, M. Sc
Role: backup
References
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Maury S, Lemoine FM, Hicheri Y, Rosenzwajg M, Badoual C, Cherai M, Beaumont JL, Azar N, Dhedin N, Sirvent A, Buzyn A, Rubio MT, Vigouroux S, Montagne O, Bories D, Roudot-Thoraval F, Vernant JP, Cordonnier C, Klatzmann D, Cohen JL. CD4+CD25+ regulatory T cell depletion improves the graft-versus-tumor effect of donor lymphocytes after allogeneic hematopoietic stem cell transplantation. Sci Transl Med. 2010 Jul 21;2(41):41ra52. doi: 10.1126/scitranslmed.3001302.
Other Identifiers
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2016-A00645-46
Identifier Type: OTHER
Identifier Source: secondary_id
P140303
Identifier Type: -
Identifier Source: org_study_id