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

Phase 1

• Conditions: Acute Myelogenous Leukemia

• Registration Number: NCT01146262
• Lead Sponsor: Nantes University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-16
• Study First Posted: 2010-06-17
• Status Verified: 2015-12
• Last Update Submitted: 2016-07-25
• Last Update Posted: 2016-07-26
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse events	6 weeks	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

Name	Time	Method
immune response	Day 14
Complete remission	18 months
Survival	18 months after injection	Overall survival (from the documentation of the second RC)

Trial Locations

Locations (1)

Cellule de Promotion de la recherche clinique; 🇫🇷 Nantes, France