All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Phase III - Study on All-Trans Retinoic Acid in Combination With Standard Induction and Consolidation Therapy in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

This is a study looking at all-trans retinoic acid in combination with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML).

First Induction Therapy:

• Cytarabine 100 mg/m² cont. i.v. days 1-5

• Idarubicin 12 mg/m² i.v. days 1, 3

  • ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28

Second Induction Therapy:

• Cytarabine 100 mg/m² cont. i.v. days 1-5

• Idarubicin 12 mg/m² i.v. days 1, 3

  • ATRA 45 mg/m² p.o. days 4-6, ATRA 15 mg/m² p.o. days 7-28

First Consolidation Therapy:

• Cytarabine 1000 mg/m² bid i.v. days 1-3

• Mitoxantrone 10 mg/m² i.v. days 2, 3

  • ATRA 15 mg/m² p.o. days 4-28

Second Consolidation Therapy

• Etoposide 100 mg/m² i.v. days 1-5

• Idarubicin 12 mg/m² i.v. days 1,3

  • ATRA 15 mg/m² p.o. days 4-28

Inclusion Criteria:

• Newly diagnosed AML defined according to the World Health Organization (WHO) classification (excluding acute promyelocytic leukemia [APL])
• Aged > 60 years
• All patients have to be informed about the character of the study. Written informed consent of each patient at study entry.
• Molecular and cytogenetical analyses on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories.

Exclusion Criteria:

• Bleeding independent of the AML
• Acute promyelocytic leukemia
• Uncontrolled infection
• Participation in a concurrent clinical study
• Insufficiency of the kidneys (creatinine > 1.5 x upper normal serum level), of the liver (bilirubin, AST or AP > 2 x upper normal serum level), severe obstruction or restrictive ventilation disorder, heart failure New York Heart Association [NYHA] III/IV
• Severe neurological or psychiatric disorder interfering with ability of giving informed consent
• No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course
• Performance status WHO > 2