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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)

Primary Purpose

Acute Myelogenous Leukemia

Status
Unknown status
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
cell therapy product
injection of the cell therapy product
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring Antitumoral immune response after autologous dendritic cells vaccination

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cellule de Promotion de la recherche clinique

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

immune response
Complete remission
Survival
Overall survival (from the documentation of the second RC)

Full Information

First Posted
June 16, 2010
Last Updated
July 25, 2016
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01146262
Brief Title
Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM)
Acronym
CD lam
Official Title
Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia
Keywords
Antitumoral immune response after autologous dendritic cells vaccination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
cell therapy product
Intervention Description
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
Procedure
Intervention Name(s)
injection of the cell therapy product
Intervention Description
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
Primary Outcome Measure Information:
Title
Adverse events
Description
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)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
immune response
Time Frame
Day 14
Title
Complete remission
Time Frame
18 months
Title
Survival
Description
Overall survival (from the documentation of the second RC)
Time Frame
18 months after injection
Other Pre-specified Outcome Measures:
Title
genomic analysis of dendritic cells
Time Frame
D7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cellule de Promotion de la recherche clinique
City
Nantes
ZIP/Postal Code
44093
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34152898
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.
Results Reference
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Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM)

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