RANDOMIZED PHASE III-STUDY ON VALPROIC ACID IN COMBINATION WITH ALL-TRANS RETINOIC ACID, STANDARD INDUCTION- AND CONSOLIDATION THERAPY IN OLDER PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-004320-13-AT

Enrollment

500

Registered

2005-07-25

Start date

2005-08-29

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

newly diagnosed acute myeloid leukemia

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: valproic

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.) Newly diagnosed AML defined according the WHO-classification (excluding APL) 2.) Age >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) yes 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Improvement of event-free survival rate ;Secondary Objective: 1.) Investigation of the safety profile of valproic acid during induction and consolidation therapy 2.) Investigation of the influence of valproic acid on the CR-rate after induction therapy 3.) Investigation of the influence of valproic acid on the cumulative incidence of relapse and the cumulative incidence of death in CR 4.) Investigation of the influence of valproic acid on overall survival ;Primary end point(s): event-free survival	—

Measure

Time frame

Main Objective: Improvement of event-free survival rate ;Secondary Objective: 1.) Investigation of the safety profile of valproic acid during induction and consolidation therapy 2.) Investigation of the influence of valproic acid on the CR-rate after induction therapy 3.) Investigation of the influence of valproic acid on the cumulative incidence of relapse and the cumulative incidence of death in CR 4.) Investigation of the influence of valproic acid on overall survival ;Primary end point(s): event-free survival

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026