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Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic 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: NCT00028847
Recruitment Status : Unknown
Verified August 2011 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 17, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate and chemotherapy may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate plus cytarabine in treating patients who have newly diagnosed chronic myeloid leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: cytarabine Drug: imatinib mesylate Phase 1 Phase 2

Detailed Description:


  • Determine the maximum tolerated dose of imatinib mesylate and cytarabine in patients with newly diagnosed chronic phase chronic myeloid leukemia.
  • Determine the feasibility of this regimen as defined by dose-limiting toxicity of this regimen and treatment-related mortality in no more than 5% of these patients.
  • Determine the rate and duration of molecular response, complete hematological response, and complete cytogenetic response in patients treated with this regimen.
  • Determine the time to treatment failure of patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate and cytarabine.

Patients receive oral imatinib mesylate alone once daily on days 1-21. Patients then receive oral imatinib mesylate once daily and cytarabine IV over 1-3 hours on days 1-7. Combination therapy repeats every 28-42 days for 2 courses. Patients then receive maintenance oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 5-20 patients receive escalating doses of imatinib mesylate and cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 5/5, 5/10, or 5/20 patients experience dose-limiting toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Primary Purpose: Treatment
Official Title: A Dose-ranging Phase I/II Study of STI571 in Combination With Cytarabin in Patients With First Chronic Phase Chronic Myeloid Leukemia
Study Start Date : April 2001

Primary Outcome Measures :
  1. Incidence of dose-limiting toxicity and treatment-related toxicity per dose level

Secondary Outcome Measures :
  1. Rate and duration of molecular response
  2. Rate and duration of complete hematological response
  3. Rate and duration of complete cytogenetic response
  4. Time to treatment failure
  5. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Newly diagnosed chronic myeloid leukemia in first chronic phase (within the past 6 months)

    • Philadelphia-chromosome positive OR
    • bcr-abl rearrangement
  • No prior treatment within the past 6 months other than hydroxyurea



  • 18 to 65

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • Not specified


  • No hepatic dysfunction
  • Bilirubin less than 2 times normal
  • ALT less than 4 times normal


  • No renal dysfunction
  • Creatinine less than 2.3 mg/dL


  • No severe cardiac dysfunction
  • No New York Heart Association class II-IV heart disease


  • No severe pulmonary disease


  • HIV negative
  • No severe neurologic disease
  • No active uncontrolled infection
  • No other active malignancy within the past 5 years except basal cell skin cancer or stage 0 cervical cancer
  • Not pregnant or nursing


Biologic therapy:

  • See Disease Characteristics
  • No concurrent allogeneic transplantation with an HLA-A, B, DR-matched sibling donor or matched-unrelated donor


  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics


  • See Disease Characteristics


  • See Disease Characteristics


  • No concurrent grapefruit or grapefruit juice

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): NCT00028847

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AZ Sint-Jan
Brugge, Belgium, 8000
Institut Jules Bordet
Brussels, Belgium, 1000
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Clinique Universitaire De Mont-Godinne
Mont-Godinne Yvoir, Belgium, 5530
HagaZiekenhuis - Locatie Leyenburg
's-Gravenhage, Netherlands, 2545 CH
Meander Medisch Centrum
Amersfoort, Netherlands, 3816 CP
Vrije Universiteit Medisch Centrum
Amsterdam, Netherlands, 10P 1HV
Academisch Medisch Centrum at University of Amsterdam
Amsterdam, Netherlands, 1105 AZ
Medisch Spectrum Twente
Enschede, Netherlands, 7500 KA
University Medical Center Groningen
Groningen, Netherlands, 9713 EZ
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, Netherlands, 6500 HB
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3008 AE
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Isala Klinieken - locatie Sophia
Zwolle, Netherlands, 8000 GK
Sponsors and Collaborators
Commissie Voor Klinisch Toegepast Onderzoek
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Study Chair: J.J. Cornelissen, MD Daniel Den Hoed Cancer Center at Erasmus Medical Center

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00028847     History of Changes
Other Study ID Numbers: CDR0000069141
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: August 2011
Keywords provided by National Cancer Institute (NCI):
chronic phase chronic myelogenous leukemia
chronic myelogenous leukemia, BCR-ABL1 positive
Additional relevant MeSH terms:
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Enzyme Inhibitors