Trial Information

Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction Chemotherapy and Adding Intermediate Dose Cytarabine to Consolidation in Older Patients With Acute Myeloid Leukaemia

Induction therapy: Patients were randomized to receive idarubicin plus cytarabine (IC) or
the same drugs plus lomustine (ICL), the latter given at the dose of 200 mg/m2 orally at day
1. Patients with persistent leukemia in the bone marrow, defined by at least 20% marrow
cellularity with more than 5% blasts on day 14 or at a subsequent time point following
initiation of induction therapy, received a second course of induction chemotherapy
identical to the initial induction course. Non-responders to the second induction course
were taken off the protocol.

Consolidation therapy: After completing induction treatment, patients who were in complete
remission after 1 or 2 induction courses received a course of consolidation (IC’) therapy
with idarubicin and subcutaneous cytarabine. Subsequently, if stable remission persisted,
the patients received maintenance therapy or maintenance therapy preceded by a second
consolidation (IIC) with intermediate-dose cytarabine. Randomization was performed as soon
as CR was achieved.

Maintenance therapy: This was conducted in all patients with persisting CR one month after
completing the first (IC) or second (IIC) consolidation and consisted of the following: five
courses of combination chemotherapy at 1, 3, 6, 9 and 13 months from the last consolidation,
namely cytarabine (subcutaneously) and idarubicin and between these courses for one year: a
continuous regimen of methotrexate and 6-mercaptopurine, as alternating 10 day-courses .