Trial Information

PROSPECTIVE RANDOMISED STUDY TO COMPARE LOW-DOSE INTERFERON-ALPHA-n1 (WELLFERON) +/- HYDROXYUREA VS HIGH-DOSE INTERFERON-ALPHA-n1 (WELLFERON) +/- HYDROXYUREA IN PATIENTS WITH NEWLY DIAGONISED CHRONIC PHASE CHRONIC MYELOID LEUKAEMIA

OBJECTIVES: I. Compare the duration of chronic phase and survival following low- vs.
high-dose interferon alfa maintenance therapy in patients with chronic myelogenous leukemia
in chronic phase. II. Compare the toxicity profiles, assessed by WHO criteria, and the
percentage of patients requiring dose reduction or discontinuation with these two regimens.
III. Compare hematologic and cytogenetic responses every 6 months in patients treated on
these two regimens.

OUTLINE: This is a randomized study. Patients receive daily hydroxyurea until their white
blood cell count (WBC) is maintained at a normal level for 2-3 weeks. Patients are
randomized to two groups: one group receives daily high-dose interferon alfa, and the other
receives low-dose interferon alfa, 5 days per week. Both groups continue to receive
hydroxyurea at reduced doses as needed to maintain a normal WBC. Treatment continues until
disease progression occurs. Patients may receive cytarabine in addition to interferon in
either treatment arm at the investigator's discretion. Cytarabine is given subcutaneously
for 10 days every calendar month and continues in the absence of disease progression or
unacceptable toxicity. Patients are followed every 6 months for survival.

PROJECTED ACCRUAL: Approximately 800 patients will be enrolled over 8 years on this
multicenter study.