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

NCT01146262 | Unknown Phase 1

• 1 other identifier: BRD/05/10-L
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

Antitumoral immune response after autologous dendritic cells vaccination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• immune response

  Day 14

• Complete remission

  18 months

• Survival

  18 months after injection

Other Outcomes (1)

• genomic analysis of dendritic cells

  D7

Interventions

cell therapy product OTHER

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.

injection of the cell therapy product PROCEDURE

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Cellule de Promotion de la recherche clinique

Nantes, 44093, France

Location

Related Publications (1)

• 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.

  PMID: 34152898 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 17, 2010
• Study Start: November 1, 2009
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: July 26, 2016

Record last verified: 2015-12

Locations

FR (1)