RANDOMIZED PHASE II-STUDY ON VALPROIC ACID, ALL-TRANS RETINOIC ACID AND THEIR COMBINATION IN INDUCTION AND CONSOLIDATION THERAPY AS WELL AS PEGFILGRASTIM AFTER CONSOLIDATION THERAPY IN YOUNGER PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA

Phase 1

• Conditions: newly diagnosed acute myeloid leukemia

• Registration Number: EUCTR2004-004321-95-AT
• Lead Sponsor: niversity of Ulm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-21
• Study Completion: 2011-08-12
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 304

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 <br>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 <br>3.) Comparison of the prognostic value of the amount of bone marrow blasts after first induction therapy at day 15 and day 21<br>4.) Investigation of efficacy and safety of pegfilgrastim after consolidation therapy with high-dose cytarabine<br>5.) Investigation of the pharmacokinetics of pegfilgrastim after consolidation therapy with high-dose cytarabine<br>;Primary end point(s): rate of complete remission after induction therapy