Clinical trial NCT01146262: Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM)
Official title: Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myelogenous Leukemia
Keywords: Antitumoral immune response after autologous dendritic cells vaccination
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 5
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Adverse events
timeFrame: 6 weeks
Secondary outcomes:
measure: immune response
timeFrame: Day 14
measure: Complete remission
timeFrame: 18 months
measure: Survival
timeFrame: 18 months after injection
Other outcomes:
measure: genomic analysis of dendritic cells
timeFrame: D7
Locations:
city: Nantes
country: France
facility: Cellule de Promotion de la recherche clinique
Study officials:
References:
citation: Chevallier P, Saiagh S, Dehame V, Guillaume T, Peterlin P, Bercegeay S, Le Bris Y, Bossard C, Gauvrit I, Dreno B, Juge-Morineau N, Bene MC, Gregoire M. A phase I/II feasibility vaccine study by autologous leukemic apoptotic corpse-pulsed dendritic cells for elderly AML patients. Hum Vaccin Immunother. 2021 Oct 3;17(10):3511-3514. doi: 10.1080/21645515.2021.1943991. Epub 2021 Jun 21.