Trials / Unknown
UnknownNCT01146262
Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM)
Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | cell therapy product | 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. |
| PROCEDURE | injection of the cell therapy product | 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 |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2017-04-01
- Completion
- 2017-04-01
- First posted
- 2010-06-17
- Last updated
- 2016-07-26
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT01146262. Inclusion in this directory is not an endorsement.