Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM)
Conditions
Acute Myelogenous Leukemia
Conditions: official terms
Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
Antitumoral immune response after autologous dendritic cells vaccination
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: cell therapy product Type: Other
Name: injection of the cell therapy product Type: Procedure
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 65 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age between 65-75 years

- Informed consent signed

- Serology HIV, hepatitis B, hepatitis C, HTLV 1 and 2 and Syphilis always negative (new achievement tests)

- Performance Statut <=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 outpatient treatment for consolidation are possible

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
Location
Cellule de Promotion de la recherche clinique
Nantes, France
Status: Recruiting
Contact: Anne Omnes - 02 53 48 28 35 - laetitia.biron@chu-nantes.fr
Start Date
November 2009
Completion Date
June 2014
Sponsors
Nantes University Hospital
Source
Nantes University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page