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Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia in Complete Remission

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: August 20, 2009
Last updated: May 12, 2011
Last verified: May 2011

RATIONALE: Vaccines made from dendritic cells may help the body build an effective immune response to kill cancer cells.

PURPOSE: This phase I trial is studying the side effects of vaccine therapy and to see how well it works in treating patients with acute myeloid leukemia in complete remission.

Condition Intervention Phase
Biological: therapeutic autologous dendritic cells
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Pilot Study of Therapeutic Vaccination by Leukemic Blasts in Vitro Differentiated Dendritic Cells From Patients With Acute Myelogenous Leukemia in Complete Remission

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Adverse events at 6 months

Estimated Enrollment: 10
Study Start Date: June 2008
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:



  • Assess the tolerability of autologous dendritic cell vaccine in patients with acute myelogenous leukemia in complete remission.


  • Evaluate the emergence of an immune response.
  • Determine the relapse rate.
  • Assess the occurrence of residual disease.

OUTLINE: Patients receive increasing doses of blastic cells transformed in vitro by autologous dendritic cells (1/3 subcutaneously and 2/3 IV) every 3 weeks for up to 5 doses.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of acute myelogenous leukemia (AML)

    • Myelomonocytic (M4) or monocytic (M5) subtype
    • In second complete remission (CR) or later following CR1 lasting ≤ 12 months after chemotherapy that may have included an intensification regimen followed by autologous transplantation
  • No (15;17) translocation
  • No AML M3
  • HLA-A2 positivity
  • CD14 ≥ 20% on peripheral blood mononuclear cells
  • Circulating blasts ≥ 10 x 109/L (collected prior to chemotherapy) available
  • Must not be eligible for HLA-matched allogeneic transplantation
  • No progressive disease


  • Karnofsky performance status 70-100%
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No contraindication to cytopheresis or chemotherapy
  • No HIV or HTLV positivity
  • No hepatitis B or C activation
  • No prior psychological disease
  • Not deprived of liberty and able to give consent
  • Must be able to speak and read French
  • No other cancer except for basal cell or cervical


  • See Disease Characteristics
  • No concurrent participation in another clinical study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00963521

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Sponsors and Collaborators
Institut Paoli-Calmettes
OverallOfficial: Christian Chabannon, MD, PhD Institut Paoli-Calmettes
  More Information Identifier: NCT00963521     History of Changes
Other Study ID Numbers: CDR0000626786
Study First Received: August 20, 2009
Last Updated: May 12, 2011

Keywords provided by National Cancer Institute (NCI):
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms processed this record on April 28, 2017