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Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

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ClinicalTrials.gov Identifier: NCT00054431
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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Brief Summary:
This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. 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. Giving imatinib mesylate together with decitabine may kill more cancer cells

Condition or disease Intervention/treatment Phase
Accelerated Phase Chronic Myelogenous Leukemia Blastic Phase Chronic Myelogenous Leukemia Childhood Chronic Myelogenous Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Relapsing Chronic Myelogenous Leukemia Drug: imatinib mesylate Drug: decitabine Other: laboratory biomarker analysis Phase 2

Detailed Description:

OBJECTIVES:

I. Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.

II. Determine the survival rate of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Determine the effects of this regimen on gene methylation in the leukemic cells of these patients.

OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs no).

Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 20-80 patients (10-40 per stratum) will be accrued for this study within 20 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Imatinib Mesylate (Gleevec, STI-571) (NSC#716051) and Decitabine (5-AZA-2'-Deoxycitidine) (NSC#127716), in Chronic Myelogenous Leukemia in Accelerated and Blastic Phases
Study Start Date : January 2003
Actual Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment (imatinib mesylate, decitabine)
Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
 Drug: imatinib mesylate
Given orally
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec

Drug: decitabine
Given IV
Other Names:
  • 5-aza-dCyd
  • 5AZA
  • DAC

Other: laboratory biomarker analysis
Correlative studies


Outcome Measures
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Primary Outcome Measures :
  1. Complete and partial response [ Time Frame: 6 months ]
  2. Hematologic improvement [ Time Frame: Up to 1 year ]
  3. Duration of response [ Time Frame: Date of documented response until relapse, assessed up to 4 years ]

Secondary Outcome Measures :
  1. Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to 4 years ]

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

Inclusion Criteria:

  • Histologically confirmed chronic myelogenous leukemia

    • Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
    • Accelerated or non-lymphoid blastic phase
  • Performance status - ECOG 0-2
  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 2 times ULN
  • Creatinine less than 2.0 mg/dL
  • Normal cardiac function
  • No New York Heart Association class III or IV heart disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior decitabine
  • At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered
  • Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease

  • Prior imatinib mesylate allowed

    • Patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression
  • No concurrent grapefruit or grapefruit juice
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00054431


Locations
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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jean-Pierre Issa M.D. Anderson Cancer Center
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00054431    
Other Study ID Numbers: NCI-2012-02516
MDA-ID-02205
N01CM62202 ( U.S. NIH Grant/Contract )
CDR0000270678 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Leukemia, Myeloid, Accelerated Phase
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Carcinogenesis
 Neoplastic Processes
Pathologic Processes
Imatinib Mesylate
Decitabine
Azacitidine
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites