Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia

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: NCT00100971
Recruitment Status : Terminated (Protocol is withdrawn due to inadequate accrual)
First Posted : January 10, 2005
Last Update Posted : January 4, 2013
Information provided by:
Boston Medical Center

January 7, 2005
January 10, 2005
January 4, 2013
April 2004
March 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00100971 on Archive Site
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Vaccine Therapy in Treating Patients With Acute Myeloid Leukemia
Dendritic/Leukemic Fusion Cell Vaccine Therapy For AML Patients In First Remission; A Phase I Clinical Trial

RATIONALE: Vaccines made from a person's white blood cells and cancer cells may make the body build an effective immune response to kill cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with acute myeloid leukemia.



  • Determine the maximum tolerated dose of autologous dendritic and leukemic fusion cell vaccine in patients with acute myeloid leukemia.
  • Determine the toxicity of this vaccine in these patients.


  • Determine whether cellular immunity can be induced by this vaccine in these patients.

OUTLINE: This is a dose-escalation study.

At the time of diagnosis, patients undergo tumor cell harvest. Patients also undergo bone marrow aspiration to collect mononuclear cells to obtain dendritic cells (DC). If insufficient DCs are obtained, patients undergo leukapheresis to obtain a sufficient number of peripheral blood mononuclear cells (PBMC). The PBMC are treated in the laboratory with sargramostim (GM-CSF) and interleukin-4 for 5-7 days to produce DC. Leukemic blasts are fused to DC to generate the dendritic/leukemic fusion cell vaccine.

Patients then undergo standard induction chemotherapy to obtain a remission, followed by standard consolidation chemotherapy.

After completing consolidation chemotherapy, patients receive autologous dendritic and leukemic fusion cell vaccine subcutaneously every 2 weeks for a total of 4 doses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3 patients receive escalating doses of autologous dendritic and leukemic fusion cell vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 5 years.

PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for this study.

Phase 1
Primary Purpose: Treatment
  • Drug: autologous tumor cell vaccine
  • Drug: therapeutic autologous dendritic cells
  • Procedure: tumor cell-derivative vaccine therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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March 2007
March 2007   (Final data collection date for primary outcome measure)


  • Diagnosis of acute myeloid leukemia (AML) by bone marrow biopsy

    • Newly diagnosed
  • Must have adequate dendritic cells and AML blasts isolated from bone marrow and/or peripheral blood
  • No clinical evidence of CNS leukemia



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


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  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative
  • No clinically significant autoimmune disease
  • No other active malignancy except nonmelanoma skin cancer


Biologic therapy

  • More than 3 months since prior immunotherapy


  • Not specified

Endocrine therapy

  • Not specified


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Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Boston Medical Center
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Study Chair: Adam Lerner, MD Boston Medical Center
Boston Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP