Status:
UNKNOWN
Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for Acute Myelogenous Leukemia (AML) Patients in First or Second Complete Remission (CR)(CD laM)
Lead Sponsor:
Nantes University Hospital
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE1
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01146262
Start Date
November 1 2009
End Date
April 1 2017
Last Update
July 26 2016
Active Locations (1)
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1
Cellule de Promotion de la recherche clinique
Nantes, France, 44093