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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.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Start Date
March 1, 1998
Primary Completion Date
October 1, 2001
Completion Date
October 1, 2001
Last Updated
July 30, 2012
90
ACTUAL participants
Recombinant Interferon Alfa
BIOLOGICAL
Cytarabine
DRUG
Omacetaxine Mepesuccinate
DRUG
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06311227