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Cladribine, Cytarabine, and Imatinib Mesylate in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Blastic 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: NCT00258271
Recruitment Status : Completed
First Posted : November 24, 2005
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
University of Rochester

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as cladribine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving cladribine and cytarabine together with imatinib mesylate may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate when given together with cladribine and cytarabine in treating patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Biological: filgrastim Drug: cladribine Drug: cytarabine Drug: imatinib mesylate Phase 1

Detailed Description:


  • Determine the safety and feasibility of cladribine, cytarabine, and imatinib mesylate in patients with refractory or relapsed acute myeloid leukemia or blastic phase chronic myelogenous leukemia.
  • Determine the maximum tolerated dose of imatinib mesylate in patients treated with this regimen.
  • Correlate the expression of c-kit and the presence of c-kit mutations with clinical response in patients treated with this regimen.
  • Correlate the in vitro inhibitory effects of imatinib mesylate and cytarabine on the proliferation and survival of leukemic cells with clinical response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of imatinib mesylate.

Patients receive oral imatinib mesylate once daily on days 1-15 and cladribine IV over 2 hours and cytarabine IV over 4 hours on days 3-7. Patients also receive filgrastim (G-CSF) subcutaneously on days 2-7. Treatment repeats every 15 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of imatinib mesylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically for up to 1 year.

PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Primary Purpose: Treatment
Official Title: A Phase I Study of CLAG Regimen in Combination With Imatinib Mesylate (Gleevec) in Refractory or Relapsed Leukemias
Study Start Date : March 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

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 acute myeloid leukemia (AML) or blastic phase chronic myelogenous leukemia (CML)

    • Refractory AML defined as any of the following:

      • Failure to achieve complete response (CR) after 2 courses of induction chemotherapy
      • Persistent bone marrow blasts > 40% after 1 course of induction chemotherapy
      • Relapse of disease within 3 months since CR
    • Relapsed AML defined as the following:

      • Any evidence of disease recurrence after CR (early relapse occurs within 3-12 months and late relapse occurs > 12 months later)
    • No acute promyelocytic leukemia (AML-M3 FAB subgroup)


Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Not specified


  • Bilirubin ≤ 2.0 mg/dL
  • AST ≤ 2.5 times upper limit of normal
  • No known chronic liver disease (e.g., chronic active hepatitis or cirrhosis)


  • Creatinine < 2.5 mg/dL (if 2.0-2.5 mg/dL, glomerular filtration rate must be measured and dose of cytarabine adjusted if necessary)


  • No New York Heart Association grade III-IV heart disease
  • No congestive heart failure
  • No myocardial infarction within the past 6 months
  • Ejection fraction ≥ 30%


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
  • No uncontrolled systemic active infection
  • No known HIV infection
  • No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs
  • No history of other curatively treated malignancy except nonmelanoma skin cancer


Biologic therapy

  • No other concurrent biologic agents


  • See Disease Characteristics
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent birth control pills


  • More than 1 week since any prior investigational agent
  • No other concurrent investigational agents or therapies
  • No other concurrent anticancer agents
  • No concurrent therapeutic anticoagulation with warfarin

    • Low molecular weight heparin or heparin allowed for therapeutic anticoagulation
    • Mini-dose warfarin (e.g., 1 mg per day) allowed for prophylaxis of central venous catheter thrombosis

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): NCT00258271

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United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
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Principal Investigator: Camille Abboud, MD James P. Wilmot Cancer Center
Publications of Results:
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Responsible Party: University of Rochester Identifier: NCT00258271    
Other Study ID Numbers: CDR0000448638
First Posted: November 24, 2005    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Keywords provided by University of Rochester:
recurrent adult acute myeloid leukemia
adult acute basophilic leukemia
adult acute eosinophilic leukemia
adult acute megakaryoblastic leukemia (M7)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myelomonocytic leukemia (M4)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia without maturation (M1)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
blastic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
Additional relevant MeSH terms:
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Neoplasms by Histologic Type
Leukemia, Myeloid
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Neoplastic Processes
Pathologic Processes
Imatinib Mesylate
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Protein Kinase Inhibitors
Enzyme Inhibitors