Trial Information

Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction and Post-remission Chemotherapy in Older Patients With Acute Myeloid Leukaemia, and Feasibility of Allogeneic Transplantation for Patients From 60 to 65 Years Old

- Principal Objective: The primary objective of this study is to assess the ability of
lomustine to increase the overall survival by adding lomustine to induction and
post-remission chemotherapy.

- Secondary Objectives:

- To assess the ability of lomustine to increase the CR rate.

- To assess the ability of lomustine to increase the event-free survival.

- To evaluate the toxicity and side-effects of lomustine.

- To evaluate the feasibility of reduced conditioning allogeneic transplantation
*between 60 and 65 years old.

- To evaluate prognostic factors.

- To evaluate QOL in elderly.

- Study design: Parallel

- Study plan:

- Induction therapy: Patients will be randomized to receive idarubicin (5d) plus
cytarabine or the same drugs plus lomustine, the latter given at the dose of 200
mg/m2 orally at day 1.

- Consolidation therapy: After completing induction treatment, patients who are in
complete remission will receive a course of consolidation therapy with idarubicin
(3d) and subcutaneous cytarabine.

- Maintenance therapy: In all patients with persisting CR one month after
completing consolidation: six courses of monthly combination chemotherapy
(idarubicin (1d) and subcutaneous cytarabine) and then a continuous regimen of
methotrexate and 6-mercaptopurine, for 6 months.

- Allogeneic transplantation: Patients between 60 and 65 years old with a full
matched donor will receive after consolidation (if still in CR) an alloBMT with a
reduced conditioning regimen of Fludarabine (3d) and TBI (2Gy).

- Number of subjects: 460