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

Phase 1/Phase 2
65 Years
75 Years
Open (Enrolling)
Acute Myelogenous Leukemia

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Trial Information

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

Inclusion Criteria:

- Age between 65-75 years

- Informed consent signed

- Serology HIV, hepatitis B, hepatitis C, HTLV 1 and 2 and Syphilis always negative
(new achievement tests)

- Performance Statut <=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

- 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 outpatient treatment for consolidation are possible

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Adverse events

Outcome Description:

Primary objective: assess the tolerability of autologous apoptotic corps pulsed dendritic cells vaccine in in acute myelogenous leukemia patients in first or second Complete remission. (CR2)

Outcome Time Frame:

6 weeks

Safety Issue:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

November 2009

Completion Date:

June 2014

Related Keywords:

  • Acute Myelogenous Leukemia
  • Antitumoral immune response after autologous dendritic cells vaccination
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid