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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00963521
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : May 13, 2011
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Leukemia Biological: therapeutic autologous dendritic cells Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : May 2011

Primary Outcome Measures :
  1. Adverse events at 6 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00963521

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Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, France, 13273
Sponsors and Collaborators
Institut Paoli-Calmettes
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OverallOfficial: Christian Chabannon, MD, PhD Institut Paoli-Calmettes
Layout table for additonal information Identifier: NCT00963521    
Other Study ID Numbers: CDR0000626786
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: May 13, 2011
Last Verified: May 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:
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Neoplasms by Histologic Type