Informations générales (source: ClinicalTrials.gov)
Allogeneic Immunotherapy for Hematological Malignancies by Selective Depletion of Regulatory T Cells: A Confirmatory, Randomized, Double Blinded Trial
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2018
février 2026
17 septembre 2025
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 malignancies who had never shown any signs of GVHD after transplant or
after one or more DLI.
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | BECKERICH Florence | 18/10/2025 10:06:55 | Contacter | ||
| HIA PERCY | BECKERICH Florence | 18/10/2025 10:06:55 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 18/10/2025 10:06:56 | Contacter | |||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital La Pitié-Salpêtrière | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Robert Debré | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| AP-HP - Hôpital Saint Louis | |||||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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