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Interferon Alfa and Imatinib Mesylate 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: NCT00045422
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 5, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Combining interferon alfa with imatinib mesylate may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining interferon alfa with imatinib mesylate in treating patients who have chronic myelogenous leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Biological: recombinant interferon alfa Drug: imatinib mesylate Phase 2

Detailed Description:


  • Determine whether interferon alfa in combination with imatinib mesylate adds to the hematologic, cytogenetic, and molecular response rates in patients with chronic phase chronic myelogenous leukemia that is newly diagnosed or has not achieved a complete cytogenetic response to imatinib mesylate alone.

OUTLINE: Patients receive oral imatinib mesylate (STI-571) once daily for 9 months. At 9 months, patients with more than 35% Philadelphia chromosome-positive (Ph+) cells in bone marrow receive oral STI-571 twice daily for 3 more months. At 12 months, patients with more than 35% Ph+ cells in bone marrow receive oral STI-571 once daily and interferon alfa subcutaneously once daily. Treatment continues for at least 1 year in the absence of disease progression or unacceptable toxicity. Patients with an appropriate HLA-matched donor may choose to have a bone marrow transplantation at any time during the study.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 80 patients (60 without an HLA-matched donor and 20 with an HLA-matched donor) will be accrued for this study within 5 years.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Open Label Study to Determine Safety and Efficacy of Interferon-alpha in Combination With Imantinib Mesylate (Gleevec) in Patients With Chronic Phase Chronic Myelogenous Leukemia Who Have Not Achieved a Complete Cytogenetic Response to Gleevec as a Single Agent
Study Start Date : April 2002
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Diagnosis of chronic phase chronic myelogenous leukemia

    • Cytogenetically confirmed Philadelphia chromosome-positive disease or other variant of t(9;22)

      • No secondary chromosomal abnormalities
    • No more than 10% blasts in bone marrow
    • Newly diagnosed OR
    • Received prior imatinib mesylate as a single agent for no more than the past 9 months without achieving a complete cytogenetic response
  • No evidence of extramedullary involvement except nodes, liver, or spleen



  • Any age

Performance status

  • ECOG 0-3

Life expectancy

  • Not specified


  • Platelet count greater than 100,000/mm^3
  • Absolute neutrophil count greater than 1,500/mm^3


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT no greater than 2 times ULN
  • INR no greater than 1.5 times ULN*
  • PTT no greater than 1.5 times ULN* NOTE: * Except patients on anticoagulants


  • Creatinine no greater than 2 times ULN


  • Considered potentially reliable
  • No history of noncompliance to medical regimens
  • No other active malignancy requiring chemotherapy or radiotherapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier-method contraception during and for at least 3 months after study


Biologic therapy

  • No prior interferon therapy
  • No prior stem cell or bone marrow transplantation


  • No prior chemotherapy (except hydroxyurea and/or anagrelide to control counts)

Endocrine therapy

  • Not specified


  • Not specified


  • At least 4 weeks since prior major surgery and recovered


  • No concurrent grapefruit juice or grapefruit products
  • No concurrent warfarin
  • Concurrent low-molecular weight heparin 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): NCT00045422

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Ellin Berman, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00045422    
Other Study ID Numbers: 02-013
CDR0000256469 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 5, 2013
Last Verified: June 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
chronic myelogenous leukemia, BCR-ABL1 positive
chronic phase chronic myelogenous leukemia
childhood chronic myelogenous leukemia
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action