Trial Information

PROSPECTIVE RANDOMISED STUDY TO COMPARE INTERFERON-ALPHA-n1 (WELLFERON) VS 'IDAC' CHEMOTHERAPY AND AUTOGRAFTING FOLLOWED BY INTERFERON ALPHA-n1 (WELLFERON) IN PATIENTS WITH NEWLY DIAGNOSED CHRONIC PHASE CHRONIC MYELOID LEUKEMIA

OBJECTIVES: I. Compare overall survival in patients with chronic myelogenous leukemia in
chronic phase treated with interferon alfa with or without cytarabine vs autologous
peripheral blood stem cell transplantation followed by interferon alfa with or without
cytarabine. II. Compare the time to blast transformation with these treatment regimens in
these patients. III. Compare the number of these patients reverting to Philadelphia
chromosome (Ph) negative hematopoiesis with these treatment regimens. IV. Compare the
complete and major cytogenetic response rates in these patients at one year after receiving
these treatment regimens and annually thereafter. V. Compare the hematological remission
rate in these patients after receiving these treatment regimens. VI. Compare the duration of
hematological remission and its impact on survival and blastic transformation in these
patients after receiving these treatment regimens. VII. Compare the duration of Ph negative
hemapoiesis and its impact on survival and blastic transformation in these patients after
receiving these treatment regimens. VIII. Determine the number of these patients who fail
one treatment regimen and can be rescued with the alternative. IX. Compare quality of life
in these patients with these treatment regimens. X. Determine the number of these patients
who tolerate these two regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms. Arm I: Patients undergo mobilization chemotherapy with a regimen of the
center's choice, such as either of the following: Patients receive idarubicin IV over 10
minutes, etoposide IV over 2 hours, and cytarabine IV over 2 hours on days 1-3; and
filgrastim (G-CSF) subcutaneously (SC) starting day 11 and continuing until blood counts
recover. OR Patients receive hydroxyurea IV daily until the neutrophil count drops below
1,000/mm3 or the platelet count drops below 20,000/mm3 followed by G-CSF SC for 3
consecutive days or until leukapheresis is complete. Following mobilization therapy,
patients undergo leukapheresis within 6 months of diagnosis. Patients then undergo
cytoreductive therapy consisting of oral busulfan on days -5 to -2. Autologous peripheral
blood stem cells are infused on day 0. Once blood counts have recovered, patients receive
interferon alfa SC 3 times a week for 8 weeks, and then daily for at least a total of 6
months or until disease progression. At the discretion of the treating physician, patients
may also receive cytarabine SC once a day for 10 days each month, beginning 2 weeks after
the interferon alfa therapy begins and continuing until complete cytogenetic response is
achieved. Arm II: Patients receive interferon alfa SC 3 times a week for 4 weeks, and then
daily for 6 months. If hematological remission is achieved after 6 months, interferon
treatment is continued for at least another 6 months or until disease progression. At the
discretion of the treating physician, patients may also receive cytarabine as in arm I.
Quality of life is assessed at defined intervals. Patients are followed for at least 2
years.

PROJECTED ACCRUAL: Approximately 744 patients will be accrued for this study within 5 years.