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

Acute Myelogenous Leukemia Clinical Trial

— CD lam  

Official title:

Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01146262
• Other study ID #: BRD/05/10-L
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: June 16, 2010
• Last updated: July 25, 2016
• Start date: November 2009
• Est. completion date: April 2017

Study information

• Verified date: December 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• 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.

Procedure:
• 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

Locations

Country	Name	City	State
France	Cellule de Promotion de la recherche clinique	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	genomic analysis of dendritic cells		D7	No
Primary	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	Yes
Secondary	immune response		Day 14	No
Secondary	Complete remission		18 months	No
Secondary	Survival	Overall survival (from the documentation of the second RC)	18 months after injection	No