Imatinib Mesylate in Treating Patients With Chronic Myelogenous Leukemia

Completed · Phase 2

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

In brief

This phase II trial is studying imatinib mesylate to see how well it works in treating patients with chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth

Key facts

Study ID

NCT00030394

Run by

National Cancer Institute (NCI)

People needed

64

Starts

2002-09-01

Last updated by the study team

2013-01-17

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Philadelphia chromosome positive (Ph+) chronic phase chronic myelogenous leukemia (CML)
• Stratum I (closed to accrual as of 12/05/03):
• CML in first chronic phase with resistance to interferon alfa (IFN-A) therapy defined as one of the following:
• WBC count at least 20,000/mm\^3 after at least 3 months of treatment with an IFN-A-containing regimen
• Rising WBC count (at least 100% increase to a level of at least 20,000/mm\^3) by two samples at least two weeks apart while receiving treatment with an IFN-A-containing regimen
• At least 66% Ph+ cells in bone marrow after 1 year of IFN-A therapy
• At least 30% increase in Ph+ cells in bone marrow after IFN-A-induced cytogenetic response while continuing to receive IFN-A therapy
• Intolerance to interferon therapy defined as more than two grade 2 toxic effects or any grade 3 toxic effect related to interferon therapy, except grade 3 fever, that is persistent beyond the first 28-day course of therapy and unresponsive to standard supportive care interventions
• Stratum II (closed to accrual as of 7/29/05): CML recurring after stem cell transplantation or in second or subsequent chronic phase
• No molecular relapse (only evidence is detection of bcr-abl rearrangement with normal bone marrow and blood morphology and normal standard cytogenetic analysis)
• Stratum III (closed to accrual as of 7/29/05): Newly diagnosed CML in first chronic phase with no prior treatment except hydroxyurea
• Stratum IV: Newly diagnosed CML in first chronic phase with no prior treatment except hydroxyurea
• No accelerated or blast phase defined as one or more of the following:
• WBC doubling time less than 5 days
• Chloroma
• Medullary fibrosis
• More than 10% blasts in peripheral blood or bone marrow
• More than 20% promyelocytes in peripheral blood or bone marrow
• More than 20% basophils and eosinophils in peripheral blood
• Performance status - ECOG 0-2
• At least 8 weeks
• See Disease Characteristics
• Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by radionuclide angiogram
• Bilirubin no greater than 1.5 times normal
• ALT less than 3.0 times normal

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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