This trial is active, not recruiting.

Condition acute myelogenous leukemia
Treatments cell therapy product, injection of the cell therapy product
Phase phase 1/phase 2
Sponsor Nantes University Hospital
Start date November 2009
End date April 2017
Trial size 5 participants
Trial identifier NCT01146262, BRD/05/10-L


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Adverse events
time frame: 6 weeks

Secondary Outcomes

immune response
time frame: Day 14
Complete remission
time frame: 18 months
time frame: 18 months after injection

Eligibility Criteria

Male or female participants at least 60 years old.

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

Additional Information

Official title Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Nantes University Hospital.