Multizentrische Therapieoptimierungsstudie AML-BFM 2004 zur Behandlung der akuten myeloischen Leukämien bei Kindern und JugendlichenMulticentric therapy optimizing study AML-BFM 2004 for the treatment of acute myeloic leukaemias for children and juveniles - AML-BFM 2004

Conditions: For acute myeloic leukaemia in children and juveniles improvment of treatment with new medications should be investigated:1. Cladribine: originally licenced for hairy cell leukamia has shown good success in the USA in the treatment of aml in children, esp. for high-risk-patients2. Daunoxome: liposomal form of Idarubicin (already in use for aml treatment, but with a dose rate depending risk of heart degradation). It should be proved, if Daunoxome could be administered with less side effects
MedDRA version: 8.1Level: LLTClassification code 10001941Term: AM

Registration Number: EUCTR2006-004710-41-AT

Lead Sponsor: St. Anna Kinderkrebsforschung

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 550

Inclusion Criteria

- age 0-18 y
- de novo AML, including Down Syndrome, primary Myelosarkoma or Acute Mixed Lineage
- treatment in the participating centers in Austria
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

- AML als secondary malignant tumour
- patients with primary syndroma (exception Down Syndrom)
- Pregnancy
- treatment for more than 14 days with different intense Induction Therapy
- conducting diseases than ban the intented therapy according protocoll AML-BFM 2004

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Improved prognosis of AML children:<br>1. randomized administration of liposomal daunorubicin vs idarubicin<br>2. randomized administration of 2-CDA (Cladribine) for intense consolidation therapy for aml high-risk-patients<br>3. randomized survey of the efficiency of prophylactic CNS-irradiation 18 Gy vs 12 Gy total dose on equality;Secondary Objective: Avoidance of antracycline-induced cardiotoxicity by the administration of liposomal daunorubicin (Daunoxome);Primary end point(s): overall and event-free survival (for 1 and 2)<br>for 3: disease-free survival

Secondary Outcome Measures