Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

Completed · Phase 2

Conditions studied: Accelerated Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Childhood Chronic Myelogenous Leukemia, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Relapsing Chronic Myelogenous Leukemia

In brief

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

Key facts

Study ID

NCT00054431

Run by

National Cancer Institute (NCI)

People needed

80

Starts

2003-01-01

Last updated by the study team

2013-01-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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