Acute Myeloid Leukemia
Conditions
Keywords
age > 60 years
Brief summary
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).
Detailed description
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
Interventions
DRUGCytarabine
100mg/m² kont. i.v. day 1-5 (induction therapy); 1000 mg/m² 2x/die i.v. day 1-3 (first consolidation cycle)
DRUGIdarubicin
12mg/m² i.v. day 1+3 (induction therapy); 12mg/m² i.v. Tag 1+3 (second consolidation cycle)
DRUGAll-trans retinoic acid
45mg/m² p.o. day 4-6, 15mg/m² p.o. day 7-28 (induction therapy); 15mg/m² p.o. day 4-28 (consolidation therapy)
DRUGMitoxantrone
10mg/m² i.v. day 2-3 (first consolidation cycle)
DRUGEtoposid
100mg/m² i.v. Tag 1-5 (second consolidation cycle)
Sponsors
University of Ulm
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
61 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| event-free survival | two years |
Secondary
| Measure | Time frame |
|---|---|
| kind, incidence, severity, temporal sequence and correlation of side effects of the study drugs | during therapy |
| complete remission (CR) rate after induction therapy | after second induction cycle |
| cumulative incidence of relapse | two years |
| cumulative incidence of death | two years |
| overall survival | two years |
Countries
Austria, Germany
Outcome results
None listed