Phase II Study of Cladribine, High-dose Cytarabine and Idarubicin in Patients With Relapsed Acute Myeloid Leukemia
Considerable progress has been made in the induction therapy of acute myeloid leukemia
(AML); however, current therapeutic results are still unsatisfactory in those with relapsed
disease. The purine nucleoside analogue cladribine (2-chlorodeoxyadenosine, 2-CdA) has been
shown to be a safe and active agent in acute myeloid leukemia. Synergistic interaction
between cladribine and cytarabine has been demonstrated in preclinical and clinical studies.
The current multicenter phase II study was initiated to evaluate the efficacy and toxicity
of cladribine, high-dose cytarabine, and idarubicin in the treatment of patients with
relapsed AML. Adult patients of all age groups can be enrolled in the trial, but elderly
patients will be treated with a less dose-intensive regimen.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity according to National Cancer Institute/Common Toxicity Criteria (NCI/CTC), especially the rate of severe infections and the death rate
Marie von Lilienfeld-Toal, MD
Medical Clinic & Policlinic III, University Hospital Bonn
Germany: Federal Institute for Drugs and Medical Devices