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Vaccine Therapy in Treating Patients With Chronic Myelogenous 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.
ClinicalTrials.gov Identifier: NCT00004052
Recruitment Status : Completed
First Posted : May 8, 2003
Last Update Posted : June 25, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

December 10, 1999
May 8, 2003
June 25, 2013
March 1999
August 2005   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004052 on ClinicalTrials.gov Archive Site
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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Phase II, Multicenter Vaccination of Patients With Chronic Myelogenous Leukemia With a Multivalent Tumor Specific Breakpoint Peptide Vaccine

RATIONALE: Vaccines may make the body build an immune response to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.


  • Determine the safety and immunogenicity of a multivalent tumor-specific breakpoint peptide vaccine in patients with chronic myelogenous leukemia.
  • Determine the antileukemic effects of vaccination with these peptides in these patients.

OUTLINE: Patients receive bcr/abl breakpoint peptide vaccine in QS21 adjuvant subcutaneously at rotated sites every 1-3 weeks (on or about days 0, 7, 21, 35, and 56) over 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients demonstrating a response by week 10 may receive 3 additional monthly vaccinations initiated within 8 weeks of the fifth dose. Patients demonstrating a response by vaccination 8 may receive 3 additional vaccinations administered at two-month intervals.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.

Phase 2
Primary Purpose: Treatment
  • Biological: QS21
  • Biological: bcr-abl peptide vaccine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
August 2005
August 2005   (Final data collection date for primary outcome measure)


  • Histologically proven chronic myelogenous leukemia

    • Must have (9;22) translocation or bcr/abl transcript, and b3a2 breakpoint
    • No accelerated or blastic phase
  • Must be in hematologic remission with peripheral WBC less than 20,000/mm^3



  • Over 16

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • See Disease Characteristics
  • Absolute granulocyte count greater than 1,200/mm^3
  • Platelet count greater than 70,000/mm^3
  • Hemoglobin greater than 9.0 g/dL
  • No active bleeding


  • Bilirubin less than 2.0 mg/dL
  • Lactate dehydrogenase less than 2 times normal


  • Creatinine less than 2.0 mg/dL


  • No New York Heart Association class III or IV heart disease


  • No uncontrolled active infection requiring antibiotics
  • No other serious illness
  • No immunodeficiency other than from prior bone marrow transplantation
  • Not pregnant or nursing


Biologic therapy:

  • At least 6 months since prior allogeneic or autologous bone marrow transplantation
  • Prior vaccination with pentavalent peptide at less than study dose level allowed
  • At least 4 weeks since prior immunotherapy other than interferon, donor lymphocyte infusion, or pentavalent vaccine
  • Concurrent interferon allowed


  • At least 2 weeks since prior low-dose subcutaneous cytarabine
  • At least 4 weeks since prior chemotherapy other than hydroxyurea
  • No concurrent chemotherapy except hydroxyurea

Endocrine therapy:

  • No concurrent corticosteroids


  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • No concurrent surgery


  • Concurrent imatinib mesylate allowed
  • No other concurrent systemic therapy
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000067247 ( Registry Identifier: PDQ (Physician Data Query) )
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Kathleen Cathcart, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
June 2013

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