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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-004710-41-AT
Enrollment
550
Registered
2006-10-25
Start date
2006-11-26
Completion date
Unknown
Last updated
2015-10-26

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

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-patients 2. 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 Me

Interventions

Trade Name: 1. Cladribine Product Name: 1. Cladribine Product Code: unknown Pharmaceutical Form: Intravenous infusion Trade Name: 2. Daunoxome Product Name: Daunoxome Product Code: inknown Pharmaceu

Sponsors

St. Anna Kinderkrebsforschung
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Improved prognosis of AML children: 1. randomized administration of liposomal daunorubicin vs idarubicin 2. randomized administration of 2-CDA (Cladribine) for intense consolidation therapy for aml high-risk-patients 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) for 3: disease-free survival—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 5, 2026