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Summary
EudraCT Number:2006-004710-41
Sponsor's Protocol Code Number:AMLBFM0401
National Competent Authority:Austria - BASG
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2006-10-25
Trial results View results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedAustria - BASG
A.2EudraCT number2006-004710-41
A.3Full title of the trial
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
A.3.2Name or abbreviated title of the trial where available
AML-BFM 2004
A.4.1Sponsor's protocol code numberAMLBFM0401
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorSt. Anna Kinderkrebsforschung
B.1.3.4CountryAustria
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name 1. Cladribine
D.2.1.1.2Name of the Marketing Authorisation holder1. Lipomed GmbH
D.2.1.2Country which granted the Marketing AuthorisationAustria
D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
D.2.5.1Orphan drug designation numberEU/3/01/055 Cladribine (Litak)
D.3 Description of the IMP
D.3.1Product name1. Cladribine
D.3.2Product code unknown
D.3.4Pharmaceutical form Intravenous infusion
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name 2. Daunoxome
D.2.1.1.2Name of the Marketing Authorisation holderGilead
D.2.1.2Country which granted the Marketing AuthorisationAustria
D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameDaunoxome
D.3.2Product code inknown
D.3.4Pharmaceutical form Intravenous infusion
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntravenous use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
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
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 8.1
E.1.2Level LLT
E.1.2Classification code 10001941
E.1.2Term AML
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
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
E.2.2Secondary objectives of the trial
Avoidance of antracycline-induced cardiotoxicity by the administration of liposomal daunorubicin (Daunoxome)
E.2.3Trial contains a sub-study No
E.3Principal 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
E.4Principal 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
E.5 End points
E.5.1Primary end point(s)
overall and event-free survival (for 1 and 2)
for 3: disease-free survival
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response Yes
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo No
E.8.2.3Other No
E.8.2.3.1Comparator description
Idarubicin/ 2-CDA + Cytarabin+Idarubicin vs Cytarabin + Idarubicin
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned5
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA80
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial has a data monitoring committee Yes
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
01.03.2004 - 28.02.2009
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years2
E.8.9.1In the Member State concerned months5
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years4
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) Yes
F.1.1.4Infants and toddlers (28 days-23 months) Yes
F.1.1.5Children (2-11years) Yes
F.1.1.6Adolescents (12-17 years) Yes
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
newborn, toddlers and young children -> consent of parents
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state80
F.4.2 For a multinational trial
F.4.2.1In the EEA 500
F.4.2.2In the whole clinical trial 550
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
We expect more information for a still better treatment for young aml-patients
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2006-11-26
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-10-10
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2015-10-25

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