Trials / Completed
CompletedNCT02405338
DC Vaccination for Post-remission Therapy in AML
Dendritic Cell-based Active Immunotherapy of Patients With Acute Myeloid Leukemia Using Autologous Cells Transfected With RNA Encoding Two Different Leukemia-associated Antigens
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Medigene AG · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | WT1/PRAME vaccination |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2019-11-01
- Completion
- 2019-11-01
- First posted
- 2015-04-01
- Last updated
- 2020-07-07
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT02405338. Inclusion in this directory is not an endorsement.