Conditions: Chronic Myelogenous Leukemia
Keywords: CML STI571 imatinib interferon interferon alpha cytosine arabinoside chronic myeloid leukemia Philadelphia chromosome positive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 1106
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate and compare the side effects and anti-leukemic benefits of imatinib with those of interferon and Ara-C for patients who have chronic myeloid leukemia (CML) in the chronic phase. Patients in this study will be randomized (1:1) to receive either interferon plus Ara-C or imatinib as initial treatment.

Detailed description:

Arms:
arm 1: In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injection for 10 days every month. Maximum study duration was 11.5 years. arm 2: In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m\^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10\^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.

Interventions: intervention 1: imatinib mesilate intervention 2: interferon-alpha (INF-a) intervention 3: cytarabine (ARA-C)
Intervention descriptions: intervention 1: imatinib supplied as 100 mg and 400 mg tablets or 100 mg capsules. intervention 2: interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m\^2/day. intervention 3: cytarabine 20 mg/m\^2/day (max 40 mg) SC for 10 days every month.

Protocol document: