Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM)
This trial is active, not recruiting.
|Condition||acute myelogenous leukemia|
|Treatments||cell therapy product, injection of the cell therapy product|
|Phase||phase 1/phase 2|
|Sponsor||Nantes University Hospital|
|Start date||November 2009|
|End date||April 2017|
|Trial size||5 participants|
|Trial identifier||NCT01146262, BRD/05/10-L|
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).
|Endpoint classification||safety study|
|Intervention model||single group assignment|
time frame: 6 weeks
time frame: Day 14
time frame: 18 months
time frame: 18 months after injection
Male or female participants at least 60 years old.
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. Exclusion Criteria - 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
|Official title||Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR|
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