Leukemia Clinical Trial
Official title:
Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Alpha Interferon (IFN-A), Low-Dose Cytosine Arabinoside (ARA-C), and Homoharringtonine (HHT)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining biological therapy with chemotherapy may kill more
cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy with cytarabine and
homoharringtonine and biological therapy with interferon alfa in treating patients with
chronic phase chronic myelogenous leukemia.
OBJECTIVES: I. Determine the effectiveness of low dose cytarabine, homoharringtonine, and
interferon alfa in stimulating a complete cytogenic response in patients with Philadelphia
chromosome positive early chronic phase chronic myelogenous leukemia. II. Evaluate the
duration of the cytogenic response in these patients after this treatment. III. Determine
differential success rates and analyze results by prognostic subsets (e.g., risk group,
splenomegaly, thrombocytosis, age, etc.) in this patient population.
OUTLINE: Patients receive debulking therapy consisting of hydroxyurea until blood count is
at proper level. Patients then receive interferon alfa and cytarabine daily by subcutaneous
injection. Homoharringtonine is administered by continuous infusion on days 1-5. Treatment
continues for 5-7 years in the absence of unacceptable toxicity or disease progression
(accelerated or blastic phase CML). If complete remission is achieved, peripheral blood stem
cells are collected. Patients are followed every 3 months for the first year and every 6
months thereafter.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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