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

Phase 1

• Conditions: newly diagnosed acute myeloid leukemia

• Registration Number: EUCTR2004-004320-13-AT
• Lead Sponsor: niversitätsklinikum Ulm / University Clinical Center Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-25
• Study Completion: 2010-06-05
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

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