DC Vaccination for Post-remission Therapy in AML
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02405338|
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : July 7, 2020
This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients.
Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Biological: WT1/PRAME vaccination||Phase 1 Phase 2|
20 patients with AML who are in remission (ELN criteria by Döhner et al 2017) receive WT1/PRAME autologous DC vaccine by intradermal injection once per week during the first 4 weeks and 1 per month thereafter for 23 consecutive months.
Primary objective is to assess the safety and tolerability of the DC vaccine in the aforementioned population and the feasibility.
Secondary objectives include evaluation of clinical response and exploratory immune monitoring assessments.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dendritic Cell-based Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Cells Transfected With RNA Encoding Two Different Leukemia-associated Antigens|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||November 2019|
|Actual Study Completion Date :||November 2019|
|Experimental: WT1/PRAME vaccination||
Biological: WT1/PRAME vaccination
- Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible [ Time Frame: 2 years ]
- Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 2 years ]
- Relapse/Progression free survival [ Time Frame: 2 years ]
- Time to progression (TTP). [ Time Frame: 2 years ]
- Control of minimal residual disease (MRD) [ Time Frame: 2 years ]
- ECOG performance status [ Time Frame: 2 years ]
- Cellular immune responses to applied antigens [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405338
|Oslo University Hospital, Rikshospitalet|
|Oslo, Norway, 0424|
|Principal Investigator:||Yngvar Fløisand||Oslo University Hospital, Rikshospitalet Department of Hematology|