Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia

Completed · Phase 2

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

In brief

Phase II trial to study the effectiveness of homoharringtonine in treating patients who have chronic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as homoharringtonine, work in different ways to stop cancer cells from dividing so they stop growing or die

Key facts

Study ID

NCT00006364

Run by

National Cancer Institute (NCI)

People needed

50

Starts

1999-11-01

Last updated by the study team

2013-01-23

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of chronic phase chronic myelogenous leukemia (CML), as defined by the following:
• Less than 15% blasts in the peripheral blood (PB) or bone marrow (BM)
• Less than 20% basophils in the PB or BM
• Platelet count > 100,000/mm\^3 (unless related to therapy)
• Absence of clonal evolution*
• Philadelphia chromosome- OR BCR/ABL-positive disease by cytogenetics, fluorescence in situ hybridization, or polymerase chain reaction
• Failed prior therapy with imatinib mesylate, as defined by any of the following:
• Failed to achieve or have lost a complete hematologic remission after 3 months of therapy
• Failed to achieve or have lost at least a minimal cytogenetic response after 6 months of therapy
• Failed to achieve or have lost a major or complete cytogenetic response after 12 months of therapy
• Unable to tolerate imatinib mesylate despite adequate dose adjustment
• Failed no more than 2 prior treatment regimens (in addition to imatinib mesylate)
• Treatment with hydroxyurea is not considered one regimen
• Ineligible for known regimens or protocols of higher efficacy or priority
• Performance status - Zubrod 0-2
• At least 2 months
• Bilirubin no greater than 2.0 mg/dL
• Creatinine less than 2.0 mg/dL
• No New York Heart Association class III or IV heart disease
• Not pregnant or nursing
• Fertile patients must use effective contraception

Where it is running

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

Full record on ClinicalTrials.gov

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