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Dendritic cells vaccinations are increasingly used in order to develop antitumoral immune response. This will be a Phase 2 trial using autologous dendritic cells pulsed with leukemic apoptotic corpse in acute myelogenous leukemia (AML) patients in first or second Complete remission (CR).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cell therapy product | Other | Patients receive for up to 5 doses of apoptotic corpse pulsed dendritic cells after CR1 ou CR2 documentation (9/10 subcutaneously and 1/10 intradermally) every week, except the last injection performed at 2 weeks from the 4th injection. | ||
| injection of the cell therapy product | Procedure | Cytapheresis D0: 1st injection of the cell therapy product, J7 2nd injection of the cell therapy product, J14 third injection of the cell therapy product,J17 cutaneous biopsies, J21 fourth injection of the cell therapy product, J35 fifth injection of the cell therapy product |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Primary objective: assess the tolerability of autologous apoptotic corps pulsed dendritic cells vaccine in acute myelogenous leukemia patients in first or second Complete remission. (CR2) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| immune response | Day 14 | |
| Complete remission | 18 months | |
| Survival |
| Measure | Description | Time Frame |
|---|---|---|
| genomic analysis of dendritic cells | D7 |
Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cellule de Promotion de la recherche clinique | Nantes | 44093 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34152898 | Derived | Chevallier P, Saiagh S, Dehame V, Guillaume T, Peterlin P, Bercegeay S, Le Bris Y, Bossard C, Gauvrit I, Dreno B, Juge-Morineau N, Bene MC, Gregoire M. A phase I/II feasibility vaccine study by autologous leukemic apoptotic corpse-pulsed dendritic cells for elderly AML patients. Hum Vaccin Immunother. 2021 Oct 3;17(10):3511-3514. doi: 10.1080/21645515.2021.1943991. Epub 2021 Jun 21. |
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Overall survival (from the documentation of the second RC)
| 18 months after injection |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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