Glivec® (Imatinib Mesylate, STI571) in Monotherapy Versus Glivec®-Interferon Alpha in the Treatment of Chronic-Phase Chronic Myeloid Leukaemia

Open, prospective, multicentre, phase IV, comparative and randomised study

Inclusion criteria

• Patients with newly-diagnosed chronic-phase Ph-positive chronic myeloid leukaemia (maximum 3 months as of the diagnosis of the disease, with the date of the cytogenetic study regarded as such).
• Age between 18 and 72 years (both included).
• Performance status < 2 on the ECOG scale (see Annex 3).
• Secure written or oral informed consent in the presence of a witness and consent for biological samples (annexes 5 and 6).

Exclusion criteria

• Criteria of acceleration or blastic crisis (see Annex 7).
• When there is a compatible family donor in patients aged under 40 years or a non-relative donor in patients aged under 30 years (in whom allogenic transplant is still regarded as first-line treatment), the possibility of performing an allogenic transplant as first therapeutic option should be considered. In any case, as this aspect is still a matter of debate, it is left up to each group to take the relevant decision depending on the institution's policy.
• Administration of other treatments before inclusion in the protocol (a maximum of 3 months of monotherapy with hydroxyurea is permitted).
• Altered hepatic or renal function (SGOT, SGPT, total bilirubin and creatinine > 1.5 times the upper limit of normality).
• Uncontrolled diseases, such as thyroidal dysfunction, diabetes mellitus, angina pectoralis, serious heart failure (functional class III/IV of the New York Heart Association classification), neuropsychiatric infection or disease (see annex 15).
• Positive serology for HIV.
• Record of cancer in the last 5 years (barring basal cell skin carcinoma and cervical carcinoma in situ).
• Pregnancy or breastfeeding