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Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase 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. Identifier: NCT00301093
Recruitment Status : Active, not recruiting
First Posted : March 10, 2006
Last Update Posted : February 8, 2019
National Cancer Institute (NCI)
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Martha Wadleigh, M.D., Dana-Farber Cancer Institute

Brief Summary:

RATIONALE: Vaccines made from gene-modified cancer cells may help the body build an effective immune response to kill cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving vaccine therapy together with imatinib mesylate may be an effective treatment for chronic myelogenous leukemia.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Biological: GM-K562 cell vaccine Drug: imatinib mesylate Phase 1

Detailed Description:



  • Determine the maximum tolerated dose of GM-K562 cell vaccine when administered with imatinib mesylate in patients with persistent chronic phase chronic myelogenous leukemia in first hematologic response.
  • Determine the safety and toxic effects of GM-K562 cell vaccination in these patients.


  • Determine the disease response by serial BCR-ABL quantitative polymerase chain reaction measurements in patients treated with this regimen.
  • Determine the development of tumor immunity in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of GM-K562.

Patients continue to receive oral imatinib mesylate at the same stable dose as before study entry. Patients receive GM-K562 subcutaneously on days 1, 8, 15, 29, 43, 57, 85, 113, and 141 in the absence of disease progression or unacceptable toxicity.

Cohorts of 10 patients receive escalating doses of GM-K562 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 10 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically for 20 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vaccination for CML Patients With Persistent Disease on Imatinib Mesylate
Study Start Date : September 2005
Actual Primary Completion Date : May 2007
Estimated Study Completion Date : January 1, 2020

Intervention Details:
  • Biological: GM-K562 cell vaccine
    Once weekly for 3 vaccination, then every other week for 3 vaccinations, and then every month for 3 vaccinations until the participant has received a total of 9 vaccinations
  • Drug: imatinib mesylate
    Participants will continue on current dose

Primary Outcome Measures :
  1. Safety and Toxicity [ Time Frame: 3 years ]
    To assess the safety and toxicity of GM-K462 vaccination in CP CML patients who have acheived a complete hematologic response to imatinib.

Secondary Outcome Measures :
  1. Disease Response [ Time Frame: 3 years ]
    To assess disease response after GM-K562 vaccination by serial BCR-ABL Q-PCR measurements

  2. Tumor immunity [ Time Frame: 3 years ]
    To characterize the development of tumor immunity in response to vaccination with GM-K562 cells

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of chronic myelogenous leukemia

    • Chronic phase disease
    • Philadelphia chromosome positive disease
  • Disease in first complete hematologic response, defined by all of the following:

    • Complete normalization of peripheral blood counts with WBC < 10,000/mm^3
    • Platelet count < 450,000/mm^3
    • No immature cells (e.g., myelocytes, metamyelocytes, or blasts) in the peripheral blood
  • Persistent molecular evidence of disease

    • Detectable BCR-ABL transcript by quantitative polymerase chain reaction
    • Less than 2 log reduction in peripheral blood or bone marrow BCR-ABL transcripts levels compared to a standardized baseline
  • Must have received imatinib mesylate for > 1 year of which the last 3 months were at stable dose ≥ 300 mg/day


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Negative pregnancy test
  • No known HIV
  • ALT or AST ≤ 3 times upper limit of normal
  • Oxygen saturation ≥ 93% at room air
  • No history of recent acute myocardial infarction
  • No history of unstable angina
  • No pulmonary decomposition requiring hospitalization within the past 3 months
  • No concurrent and/or uncontrolled psychiatric or medical condition that would preclude study compliance


  • See Disease Characteristics
  • No prior allogeneic stem cell transplantation
  • At least 2 months since other prior experimental therapy
  • At least 6 months since prior participation in another vaccine study
  • No concurrent systemic immunosuppressive medication

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): NCT00301093

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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Beth Israel Deaconess Medical Center
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Principal Investigator: Martha Wadleigh, MD Dana-Farber Cancer Institute

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Responsible Party: Martha Wadleigh, M.D., Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT00301093     History of Changes
Obsolete Identifiers: NCT00215475
Other Study ID Numbers: 04-126
R21CA115043 ( U.S. NIH Grant/Contract )
P30CA006516 ( U.S. NIH Grant/Contract )
CDR0000456445 ( Registry Identifier: NCI PDQ )
First Posted: March 10, 2006    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Keywords provided by Martha Wadleigh, M.D., Dana-Farber Cancer Institute:
chronic phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
Additional relevant MeSH terms:
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action