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Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
This study has been completed.
Study NCT00054431   Information provided by National Cancer Institute (NCI)
First Received: February 5, 2003   Last Updated: July 23, 2008   History of Changes

February 5, 2003
July 23, 2008
January 2003
 
Complete and partial response at 6 weeks after each course [ Designated as safety issue: No ]
Complete and partial response at 6 weeks after each course
Complete list of historical versions of study NCT00054431 on ClinicalTrials.gov Archive Site
Toxicity at 6 weeks after each course [ Designated as safety issue: Yes ]
Toxicity at 6 weeks after each course
 
Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
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

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. Giving imatinib mesylate together with decitabine may kill more cancer cells.

PURPOSE: 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.

OBJECTIVES:

  • Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.
  • Determine the survival rate of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • 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.

Phase II
Interventional
Treatment, Open Label
Leukemia
  • Drug: decitabine
  • Drug: imatinib mesylate
 
Oki Y, Kantarjian HM, Gharibyan V, Jones D, O'brien S, Verstovsek S, Cortes J, Morris GM, Garcia-Manero G, Issa JP. Phase II study of low-dose decitabine in combination with imatinib mesylate in patients with accelerated or myeloid blastic phase of chronic myelogenous leukemia. Cancer. 2007 Mar 1;109(5):899-906.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
80
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed chronic myelogenous leukemia

    • Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
    • Accelerated or non-lymphoid blastic phase

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 2 times ULN

Renal

  • Creatinine less than 2.0 mg/dL

Cardiovascular

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

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • 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
Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054431
 
CDR0000270678, MDA-ID-02205, NCI-5737
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Jean-Pierre Issa, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP