Study on All-Trans Retinoic Acid, Induction and Consolidation Therapy, and Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

Randomized Phase II/III-Study on All-Trans Retinoic Acid in Combination With Induction and Consolidation Therapy as Well as Pegfilgrastim After Consolidation Therapy in Younger Patients With Newly Diagnosed Acute Myeloid Leukemia

This trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (AML).

First Induction Therapy:

• Cytarabine 100 mg/m² cont. i.v. days 1-7
• Idarubicin 12 mg/m² i.v. days 1,3,5
• Etoposide 100 mg/m² i.v. days 1-3
• ± ATRA 45 mg/m² p.o. days 6-8
• ATRA 15 mg/m² p.o. days 9-21

Second Induction Therapy:

• Cytarabine 100 mg/m² cont. i.v. days 1-7
• Idarubicin 12 mg/m² i.v. days 1 and 3
• Etoposide 100 mg/m² i.v. days 1-3
• ± ATRA 45 mg/m² p.o. days 6-8
• ATRA 15 mg/m² p.o. days 9-21

Consolidation Therapy:

cohort 1 (<= ID 336)

• Cytarabine 3 g/m² 2x/die i.v. Tag 1,3,5
• ± ATRA 15 mg/m² p.o. Tag 6-21
• Pegfilgrastim 6 mg s.c day 10

cohort 2 (> ID 336)

• Cytarabine 3 g/m² 2x/die i.v. Tag 1,2,3
• ± ATRA 15 mg/m² p.o. Tag 4-21
• Pegfilgrastim 6 mg s.c day 8

Inclusion Criteria:

• Newly diagnosed AML defined according to the World Health Organization (WHO)-classification (excluding acute promyelocytic leukemia [APL])
• Ages 18-60 years
• Written informed consent of each patient at study entry.
• Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories

Exclusion Criteria:

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