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STI571 Plus Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Acute Lymphocytic 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: NCT00015860
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. STI571 may stop the growth of leukemia cells. Combining chemotherapy and STI571 may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus STI571 in treating patients who have chronic myelogenous leukemia or acute lymphocytic leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Drug: daunorubicin hydrochloride Drug: imatinib mesylate Drug: prednisone Drug: vincristine sulfate Phase 1 Phase 2

Detailed Description:


  • Determine the maximum tolerated dose of daunorubicin when combined with imatinib mesylate, vincristine, and prednisone in patients with lymphoid blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia.
  • Determine the safety of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Determine the frequency of hematologic and cytogenetic responses in patients treated with this regimen.
  • Determine the duration of response of this patient population treated with this regimen.
  • Determine the survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of daunorubicin.

Patients who have not previously received imatinib mesylate receive oral imatinib mesylate on days 1-35. Patients who have previously received imatinib mesylate for at least 28 days receive oral imatinib mesylate on days 22-35. All patients receive daunorubicin IV over 2-3 minutes on days 1-3, vincristine IV over 1 minute on days 1, 8, 15, and 22, and oral prednisone on days 1-28. Patients with more than 5% residual blasts in bone marrow on day 28 receive a second course in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of daunorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the recommended phase II dose.

PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I/II Trial of STI-571 and Chemotherapy in Lymphoid Blast Crisis of Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Lymphoid Leukemia
Study Start Date : May 2001
Actual Study Completion Date : October 2003

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


  • One of the following diagnoses:

    • Chronic myelogenous leukemia in lymphoid blast crisis
    • Acute lymphoblastic leukemia (ALL) that is in first relapse or failed induction

      • No more than 1 prior course of induction chemotherapy
      • Philadelphia chromosome-positive (Ph+) by cytogenetic analysis OR bcr/abl translocation by fluorescent in situ hybridization
  • At least 30% blasts in bone marrow
  • Ineligible for or refused allogeneic stem cell transplantation
  • Not previously treated with imatinib mesylate OR currently receiving imatinib mesylate with stable disease on 2 bone marrow biopsies at least 2 weeks apart



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • See Disease Characteristics


  • Bilirubin less than 3 times upper limit of normal (ULN)
  • ALT and AST less than 3 times ULN


  • Creatinine less than 2 times ULN


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


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for at least 2 weeks after study for female patients and at least 3 months after study for male patients


Biologic therapy:

  • See Disease Characteristics
  • No prior allogeneic bone marrow or peripheral blood stem cell transplantation
  • At least 48 hours since prior interferon alfa


  • See Disease Characteristics
  • At least 24 hours since prior hydroxyurea
  • At least 6 weeks since prior busulfan
  • Concurrent hydroxyurea or anagrelide for severe leukocytosis or thrombocytosis allowed

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified


  • No prior therapy for blast crisis except hydroxyurea
  • No prior salvage or reinduction therapy for Ph+ ALL
  • At least 4 weeks since other prior investigational agents

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): NCT00015860

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United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Oregon
Oregon Cancer Institute
Portland, Oregon, United States, 97239
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Ronald Paquette, MD Jonsson Comprehensive Cancer Center

Layout table for additonal information Identifier: NCT00015860     History of Changes
Other Study ID Numbers: CDR0000068444
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: September 2003
Keywords provided by National Cancer Institute (NCI):
recurrent adult acute lymphoblastic leukemia
relapsing chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
Additional relevant MeSH terms:
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Antineoplastic Agents, Hormonal
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neoplasms by Histologic Type
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Imatinib Mesylate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors