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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
920
100mg/m² kont. i.v. day 1-7 (induction therapy) 3g/m² 2x/die i.v. day 1,3,5 or day 1,2,3
12mg/m² i.v. day 1,3,5 (first induction cycle) 12mg/m² i.v. Tag 1,3 (second induction cycle)
100mg/m² i.v. day 1-3 (induction therapy)
Complete remission (CR)-rate after induction therapy
Time frame: after the second induction cycle
Relapse-free survival, one year after consolidation therapy with high-dose cytarabine considering different temporal sequences (1-3-5 versus 1-2-3) of the consolidation therapy
Time frame: One year after consolidation therapy
Event-free survival
Time frame: two years
Kind, incidence, severity, temporal sequence and correlation of side effects of the study-drugs
Time frame: during therapy
Cumulative incidence of relapse
Time frame: two years
Cumulative incidence of death
Time frame: two years
Overall survival
Time frame: two years
Hematological recovery as well as incidence and duration of infections during neutropenia after each consolidation cycle
Time frame: during consolidation therapy
Timely sequence of the pegfilgrastim-concentration in correlation to the absolute neutrophil counts after each consolidation cycle
Time frame: during consolidation therapy
Hematologic and non-hematologic toxicity after consolidation therapy with high-dose cytarabine considering the different consolidation schemes (day 1-3-5 versus day 1-2-3)
Time frame: during consolidation therapy
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45mg/m² p.o. day 6-8 (induction therapy) 15mg/m² p.o. day 9-21 (induction therapy) 15mg/m² p.o. day 6-21 (consolidation therapy)
6mg s.c day 10 (cohort 1), 6mg s.c. day 8 (cohort 2)
Department of Hematology/Oncology, University Hospital Innsbruck
Innsbruck, Austria
Department of Internal Medicine I, Krankenhaus der Barmherzigen Schwestern
Linz, Austria
Medical Department III, St. Johann-Hospital
Salzburg, Austria
Center of Hematology and Oncology, Hanusch-Hospital
Vienna, Austria
Department of General Internal Medicine, University Hospital of Bonn
Bonn, Germany
Medical Department I, Hospital Bremen-Mitte
Bremen, Germany
Clinical Center of Hematology and Oncology, University Hospital of Düsseldorf
Düsseldorf, Germany
Department of Hematology and Oncology, Hospital Essen Süd, Ev. Hospital of Essen-Werden
Essen, Germany
Medical Department III, Hematology/Oncology, University of Frankfurt
Frankfurt, Germany
Department of Internal Medicine III, City Hospital Frankfurt am Main - Höchst
Frankfurt, Germany
...and 24 more locations
Days in hospital after each consolidation cycle
Time frame: after consolidation therapy