Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

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

Tracking Information

• First Submitted Date: February 5, 2003
• First Posted Date: February 6, 2003
• Last Update Posted Date: January 23, 2013
• Study Start Date: January 2003
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 22, 2013)

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

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: January 22, 2013): Toxicities, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 [ Time Frame: Up to 4 years ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
• 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
• 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

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Accelerated Phase Chronic Myelogenous Leukemia
• Blastic Phase Chronic Myelogenous Leukemia
• Childhood Chronic Myelogenous Leukemia
• Chronic Myelogenous Leukemia, BCR-ABL1 Positive
• Relapsing Chronic Myelogenous Leukemia

Intervention

• 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

Study Arms

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.

Interventions:

• Drug: imatinib mesylate
• Drug: decitabine
• Other: laboratory biomarker analysis

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 20, 2007): 80
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00054431
• Other Study ID Numbers: NCI-2012-02516; MDA-ID-02205; N01CM62202 ( U.S. NIH Grant/Contract ); CDR0000270678 ( Registry Identifier: PDQ (Physician Data Query) )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: National Cancer Institute (NCI)
• Study Sponsor: National Cancer Institute (NCI)
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jean-Pierre Issa; M.D. Anderson Cancer Center

• PRS Account: National Cancer Institute (NCI)
• Verification Date: January 2013