newly diagnosed acute myeloid leukemia
Conditions
Interventions
Trade Name: Orfiril, Ergenyl
Product Name: orfiril, ergenyl
Pharmaceutical Form: Capsule*
INN or Proposed INN: INN.L24
CAS Number: 76584-07-8
Current Sponsor code: VPA
Other descriptive name: Valporic
Sponsors
University of Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.) Newly diagnosed AML defined according the WHO-classification (excluding APL) 2.) Age 18-60 years 3.) All patients have to be informed about the character of the study. Written informed consent of each patient at study entry 4.) Molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen have to be performed at the central reference laboratories Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.) Bleeding independent of the AML 2.) Acute promyelocytic leukemia 3.) Uncontrolled infection 4.) Participation in a concurrent clinical study 5.) Insufficiency of the kidneys (Crea >1.5x upper normal serum level), of the liver (bilirubine, AST or AP > 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure NYHA III/IV 6.) Severe neurological or psychiatric disorder interfering with ability of giving an informed consent 7.) No consent for the registration, storage and processing of data concerning the characteristics of the AML and the individual course 8.) Performance status WHO > 2 9.) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: rate of complete remission after induction therapy;Secondary Objective: 1.) Investigation of the safety of valproic acid, all-trans retinoic acid and their combination during induction and consolidation therapy 2.) Investigation of the influence of valproic acid, all-trans retinoic acid and their combination on the cumulative incidence of relapse and the cumulative incidence of death in CR as well as event free and overall survival 3.) Comparison of the prognostic value of the amount of bone marrow blasts after first induction therapy at day 15 and day 21 4.) Investigation of efficacy and safety of pegfilgrastim after consolidation therapy with high-dose cytarabine 5.) Investigation of the pharmacokinetics of pegfilgrastim after consolidation therapy with high-dose cytarabine ;Primary end point(s): rate of complete remission after induction therapy | — |
Countries
Austria
Outcome results
None listed