Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM)

Study Overview
=================
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).

Official Title
-----------------
Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR

Conditions
-----------------
Acute Myelogenous Leukemia

Intervention / Treatment
-----------------
* Other: cell therapy product
* Procedure: injection of the cell therapy product


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | 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) | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immune response |  | Day 14 | 
| Complete remission |  | 18 months | 
| Survival | Overall survival (from the documentation of the second RC) | 18 months after injection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antitumoral immune response after autologous dendritic cells vaccination