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

• Register: ClinicalTrials.gov
• Last refreshed on: 8 August 2016
• Main ID: NCT01146262
• Date of registration: 16/06/2010
• Prospective Registration: No
• Primary sponsor: Nantes University Hospital
• Public 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) CD lam
• Scientific title: Vaccination by Leukemic Apoptotic Corpse Autologous Pulsed Dendritic Cells for AML Patients in First or Second CR
• Date of first enrolment: November 2009
• Target sample size: 5
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT01146262
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Myelogenous Leukemia

Intervention(s)

Procedure: injection of the cell therapy product

Other: cell therapy product

Primary Outcome(s)

Adverse events [Time Frame: 6 weeks]

Secondary Outcome(s)

Survival [Time Frame: 18 months after injection]

Complete remission [Time Frame: 18 months]

immune response [Time Frame: Day 14]

Secondary ID(s)

BRD/05/10-L

Source(s) of Monetary Support

Please refer to primary and secondary sponsors