Acute Myeloid Leukemia Clinical Trial
Official title:
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
A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\m2 orally at day 1). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.
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 .
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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