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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. Identifier: NCT00030303
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
UConn Health

Brief Summary:

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

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

Condition or disease Intervention/treatment Phase
Leukemia Biological: recombinant 70-kD heat-shock protein Phase 1

Detailed Description:


  • Determine the feasibility of vaccination with autologous heat shock protein 70 in patients with chronic phase chronic myelogenous leukemia.
  • Determine the toxicity of this vaccination in these patients.

OUTLINE: Patients undergo leukapheresis to obtain peripheral mononuclear cells (PMNCs). Heat shock protein 70 (HSP70) is derived from the autologous PMNCs. Patients receive HSP70 intradermally once weekly for 8 weeks.

Patients are followed for 2 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility And Toxicity Study Of Vaccination With HSP70 For The Treatment Of Chronic Myelogenous Leukemia In Chronic Phase
Actual Study Start Date : January 2001
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Arm Intervention/treatment
Experimental: vaccine
recombinant 70-kD heat-shock protein
Biological: recombinant 70-kD heat-shock protein

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of chronic phase chronic myelogenous leukemia

    • Philadelphia chromosome positive
  • Peripheral blast count no greater than 10%
  • No molecular remission
  • Less than 3 years since initial diagnosis
  • No anticipation of requirement for bone marrow or stem cell transplantation for 6 months



  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Hemoglobin at least 10 g/dL
  • Platelet count at least 20,000/mm^3


  • Bilirubin less than 2.0 times upper limit of normal (ULN)
  • Transaminase less than 2.0 times ULN


  • Creatinine less than 2.0 mg/dL


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant active infection requiring hospitalization
  • No other serious illness or significant behavioral or psychological problem that would preclude study involvement


Biologic therapy:

  • See Disease Characteristics
  • Prior interferon alfa allowed
  • No concurrent interferon alfa


  • Prior cytarabine or other cytotoxic agents allowed
  • No concurrent cytarabine or other cytotoxic agents
  • Concurrent hydroxyurea allowed

Endocrine therapy:

  • No concurrent corticosteroid therapy


  • Not specified


  • Not specified


  • No concurrent immunosuppressive medications
  • Concurrent imatinib mesylate allowed

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): NCT00030303

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United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-1601
Sponsors and Collaborators
UConn Health
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Study Chair: Zihai Li, MD, PhD UConn Health
Publications of Results:
Li Z, Qiao Y, Laska E, et al.: Combination of imatinib mesylate with autologous leukocyte-derived heat shock protein 70 vaccine for chronic myelogenous leukemia. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-664, 2003.

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Responsible Party: UConn Health Identifier: NCT00030303    
Other Study ID Numbers: UCHC-01117
CDR0000069127 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UConn Health:
chronic phase chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases