Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)

Open-label Multicenter Trial of Glivec® (Imatinib Mesylate, Formerly Known as STI571) in Combination With Chemotherapy (MTC) in Patients With Refractory or Relapsed Acute Myeloid Leukemia (AML)

The purpose of this study is to show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.

Inclusion Criteria:

• Refractory AML after primary therapy
• First relapse after a safe previous diagnosis of de novo or secondary AML
• Age > 18 years
• Serum bilirubin < 2.0 mg/dl
• Serum creatinine < 1.5 times the normal value or a creatinine clearance > 60 ml/min
• ECG and heart echography prior to start of therapy without severe findings
• Overall condition < 2 according to ECOG criteria
• Life expectancy > 6 weeks
• Written informed consent by patients with full legal capacity

Exclusion Criteria:

• Serious secondary disease (clinically relevant cardiac disease, chronic- obstructive pulmonary disease, hepatic dysfunction, renal insufficiency)
• Active secondary neoplasia (exception: adequately treated basalioma or epidermoid cancer and cervical carcinoma)
• Known hypersensitivity to topoisomerase-I inhibitors
• Overall condition > 2 according to ECOG criteria
• Pregnant/breast feeding women
• Serious intercurrent infections