Table 5 Current clinical trials using dendritic cell vaccination for immunotherapy of AML
From: Recent developments in immunotherapy of acute myeloid leukemia
Study identifier | Study name | Type of vaccine | Antigen/target | Antigen source | Combination therapy | Clinical phase | Indication (AML only) | Primary endpoints | (Estimated) Enrollment | Sponsor | Country | Study start | (Estimated) Completion date | Status |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT00100971 | Vaccine therapy in treating patients with acute myeloid leukemia | Fusion of dendritic and leukemic cells | Multiple | Inherent | n.a. | I | De novo AML | MTD, toxicity | 9 | Boston Medical Center | USA | 2004 | 2007 | Terminated early due to slow accrual |
NCT00136422 | Study of vaccination with autologous acute myeloblastic leukemia cells in patients with advanced myelodysplasia or acute myelogenous leukemia | Lethally irradiated and genetically modified autologous AML cells | Multiple | Inherent | n.a. | I | r/r AML or de novo AML in non-fit patients | Feasibility | 30 | Dana-Farber Cancer Institute | USA | 2000 | 2006 | Completed |
NCT00510133 | A study of active immunotherapy with GRNVAC1 in patients with acute myelogenous leukemia (AML) | Monocyte-derived dendritic cells | hTERT | mRNA | n.a. | II | AML in CR1 or CR2 | Feasibility | 21 | Asterias Biotherapeutics, Inc. | USA | 2007 | 2014 | Completed |
NCT00514189 | Feasibility study of acute myelogenous leukemia mRNA plus lysate-loaded dendritic cell vaccines | Monocyte-derived dendritic cells | Multiple | AML mRNA + lysate | n.a. | I | De novo AML with non-favorable cytogenetics or AML in first relapse | Feasibility, toxicity, immunogenicity | 2 | M.D. Anderson Cancer Center | USA | 2007 | 2009 | Terminated early due to slow accrual |
NCT00834002 | Dendritic cell vaccination for patients with acute myeloid leukemia in remission (CCRG 05–001) | Monocyte-derived dendritic cells | WT1 | mRNA | n.a. | I/II | AML in CR/PR with WT1 overexpression and high risk of relapse | Feasibility, toxicity | 10 | University Hospital, Antwerp | Belgium | 2005 | 2008 | Completed |
NCT00963521 | Vaccine therapy in treating patients with acute ,myeloid leukemia in complete | In vitro-differentiated leukemic blasts | Multiple | Inherent | n.a. | I | AML in CR (CR2 or later) | Toxicity | 10 | Institut Paoli-Calmettes | France | 2008 | 2011 | Completed |
NCT00965224 | Efficacy of dendritic cell therapy for myeloid leukemia and myeloma | Monocyte-derived dendritic cells | WT1 | mRNA | n.a. | II | AML in CR with high risk of relapse | Immunogenicity, molecular response | 50 | University Hospital, Antwerp | Belgium | 2010 | 2014 | Enrolling by invitation |
NCT01096602 | Blockade of PD-1 in conjunction with the dendritic cell/AML vaccine following chemotherapy induced | Dendritic cell AML fusion vaccine | Multiple | Inherent | PD1 blockade, GM-CSF | II | AML at initial diagnosis or at first relapse | Toxicity | 63 | Beth Israel Deaconess Medical Center | USA | 2010 | 2017 | Active, not recruiting |
NCT01146262 | Vaccination by leukemic apoptotic corpse autologous pulsed dendritic cells for acute myelogenous leukemia (AML) patients in first or second complete remission (CR) (CDlaM) | Monocyte-derived dendritic cells | Multiple | AML apoptotic corpse | n.a. | I/II | AML in CR2 or refractory AML or de novo AML with unfavorable cytogenetics; no eligibility for allo-HSCT | Toxicity | 5 | Nantes University Hospital | France | 2009 | 2017 | Active, not recruiting |
NCT01373515 | Leukemic dendritic cell vaccination in patients with acute myeloid leukemia | Dendritic-like cells generated from standardized allogeneic AML cells | Multiple | Inherent | n.a. | I/II | AML in CR2 or relapsed AML or de novo AML; no eligibility for intensive therapy | Feasibility, toxicity | 12 | DCPrime BV | Netherlands | 2011 | 2013 | Completed |
NCT01686334 | Efficacy study of dendritic cell vaccination in patients with acute myeloid leukemia in remission (WIDEA) | Monocyte-derived dendritic cells | WT1 | mRNA | n.a. | II | AML in CR or Cri; WT1 overexpression | Clinical response (RR, DFS, OS) | 138 | University Hospital, Antwerp | Belgium | 2012 | 2020 | Recruiting |
NCT01734304 | DC vaccination for postremission therapy in AML | Monocyte-derived dendritic cells | WT1, PRAME | mRNA | n.a. | I/II | AML in CR or CRi with non-favorable risk profile; no eligibility for allo- | Feasibility, toxicity | 20 | Ludwig-Maximilians-University of Munich | Germany | 2012 | 2017 | Recruiting |
NCT02405338 | DC vaccination for postremission therapy in AML | Monocyte-derived dendritic cells | WT1, PRAME | mRNA | n.a. | I/II | AML in CR or Cri; WT1 overexpression; no eligibilty for allo-HSCT | Feasibility, toxicity | 20 | Medigene AG | Norway | 2015 | 2019 | Recruiting |