Acute Myelogenous Leukemia
Conditions
Keywords
Antitumoral immune response after autologous dendritic cells vaccination
Brief 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).
Interventions
OTHERcell 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.
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
Sponsors
Nantes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 60 years * Informed consent signed * Serology HIV, hepatitis B, hepatitis C, HTLV 1 and 2 and Syphilis always negative (new achievement tests) * Performance Statute \<=2 * Must not be eligible for allogeneic transplantation * No progressive disease * Bone marrow and/or peripheral blasts \>50% before chemotherapyBlasts \>=2.4 10\*8 (collected prior to chemotherapy) available No contraindication to cytapheresis * AML in CR2, except M3-AML * Patients with refractory AML after induction treatment and a patient eligible for salvage treatment may allow the production of a first complete remission. * Patient with newly diagnosed AML with unfavorable cytogenetics and for whom (which) a course of intensive induction and consolidation treatment for outpatients are possible * Patient with newly diagnosed AML with a non-adverse cytogenetics AND either refused to participate in the protocol GOELAMS LAMS-2007, against the
Exclusion criteria
, indicating participation in the protocol GOELAMS LAMS-2007 and for whom (which) a course of induction and intensive out patient treatment for consolidation are possible * Absence of donor HLA-compatible family or non-family and absence of placental blood available for performing an allograft.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 6 weeks | Primary objective: assess the tolerability of autologous apoptotic corps pulsed dendritic cells vaccine in acute myelogenous leukemia patients in first or second Complete remission. (CR2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| immune response | Day 14 | — |
| Complete remission | 18 months | — |
| Survival | 18 months after injection | Overall survival (from the documentation of the second RC) |
Other
| Measure | Time frame |
|---|---|
| genomic analysis of dendritic cells | D7 |
Countries
France
Outcome results
None listed