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)

Nantes University Hospital (NUH)

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Acute Myelogenous Leukemia

Treatments

Other: cell therapy product

Procedure: injection of the cell therapy product

Study type

Interventional

Funder types

Other

Identifiers

NCT01146262

BRD/05/10-L

Details and patient eligibility

About

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).

Enrollment

5 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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