Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM) (CD lam)
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ClinicalTrials.gov Identifier: NCT01146262
Recruitment Status : Unknown
Verified December 2015 by Nantes University Hospital. Recruitment status was: Active, not recruiting
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).
Condition or disease
Acute Myelogenous Leukemia
Other: cell therapy productProcedure: injection of the 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
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Ages Eligible for Study:
60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Patients who, for reasons psychological, social or geographical boundaries, could be monitored during the study
No infections or visceral (cardiac, lung, brain, ...) serious uncontrolled
History of positive allogeneic bone marrow or solid organ transplantation.
Previous history of autoimmune disease other than vitiligo
History of other cancer, except cervical carcinoma in situ or basal cell carcinoma of the skin unless deemed cured for over 5 years.
Inability to collect at the diagnosis of relapsed AML, enough leukemic cells (> 2.4 x108)
Inability to collect during remission, a sufficient number of monocytes in two leukapheresis maximum
Failure to obtain a maturation of monocytes
Patient with AML 3
Patient may receive an allogeneic hematopoietic stem cell
No treatment related to treatment of molecules in preclinical development underway or completed MA within the last 4 weeks