A phase I/II feasibility vaccine study by autologous leukemic apoptotic corpse-pulsed dendritic cells for elderly AML patients
oleh: Patrice Chevallier, Soraya Saiagh, Virginie Dehame, Thierry Guillaume, Pierre Peterlin, Sylvain Bercegeay, Yannick Le Bris, Céline Bossard, Isabelle Gauvrit, Brigitte Dreno, Nadine Juge-Morineau, Marie C. Béné, Marc Gregoire
| Format: | Article |
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| Diterbitkan: | Taylor & Francis Group 2021-10-01 |
Deskripsi
This was a phase I/II study testing the feasibility of a vaccine by autologous leukemic apoptotic corpse-pulsed dendritic cells (DC) in elderly acute myeloid leukemia (AML) patients in first or second complete remission. Pulsed DC were administered at doses of 9 × 106 subcutaneously (1 mL) and 1 × 106 intra-dermally (0.1 mL). Five doses of vaccine were planned on days +1 + 7 + 14 + 21 and +35. Five DC-vaccines were produced and injected for all five patients included in the study. No severe adverse event was documented. Larger Phase 2 studies are now required to precise the role of DC-vaccines with leukemic apoptotic bodies in older as well as younger AML populations. (Clinicaltrials.gov NCT01146262)