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

NCT ID: NCT01146262

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2017-04-30

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).

Conditions

Acute Myelogenous Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: OTHER

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

Intervention Type: PROCEDURE

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

Exclusion Criteria

• Absence of donor HLA-compatible family or non-family and absence of placental blood available for performing an allograft.

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cellule de Promotion de la recherche clinique

Nantes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 34152898 (View on PubMed)

Other Identifiers

BRD/05/10-L

Identifier Type: -

Identifier Source: org_study_id