Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase

Completed · Phase 2

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

In brief

Phase II trial to study the effectiveness of homoharringtonine plus low-dose cytarabine in treating patients who have newly diagnosed chronic phase chronic myelogenous leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

Key facts

Study ID

NCT00003694

Run by

National Cancer Institute (NCI)

People needed

60

Starts

1999-03-01

Last updated by the study team

2013-06-05

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic diagnosis of chronic myelogenous leukemia (CML) in chronic phase; patients in either accelerated or blastic phases are not eligible; clonal cytogenetic evolution alone does not exclude patients
• Patients must meet one or more of the following criteria:
• Cytogenetically determined Philadelphia chromosome (Ph+)
• BCR/ABL protein detectable by immunoblotting
• Polymerase chain reaction (PCR) positive fusion transcripts for BCR/ABL
• BCR/ABL translocation present by fluorescence in situ hybridization (FISH)
• Registration within eight weeks of the diagnosis and confirmation of Ph+ or BCR/ABL+ CML
• No more than eight weeks of prior hydroxyurea therapy
• No previous therapy with homoharringtonine (HHT)
• No prior treatment for CML with agents other than hydroxyurea; thus, prior treatment for CML with agents such as interferon, busulfan or cytarabine will render patients ineligible
• Must not be a candidate for an early allogeneic bone marrow transplant; potential transplant candidates must be counseled about alternative donor transplants and must decline that treatment option
• ECOG performance status 0-2
• Non-pregnant and non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control
• Bilirubin =< x upper limit of normal
• Creatinine =< 1.5 mg/dl

Where it is running

• Dana-Farber Harvard Cancer Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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