TRIAL Relapsed AML 2001/01: a randomised phase III study on the treatment of children and adolescents with refractory or relapsed acute myeloid leukaemia (AML)

ISRCTN ISRCTN94206677
DOI https://doi.org/10.1186/ISRCTN94206677
Secondary identifying numbers NTR136
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
28/04/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gertjan J.L. Kaspers
Scientific

Pediatric Oncology/Hematology
Vrije University Medical Center
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands

Phone +31 (0)20 4442420
Email gjl.kaspers@vumc.nl

Study information

Study designMulticentre, randomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymRelapsed AML 2001/01
Study objectivesAddition of liposomal daunorubicin (DaunoXome®) to fludarabine, ara-C and granulocyte colony-stimulating factor (G-CSF) (FLAG) in the first reinduction course will result in improved treatment response with acceptable toxicity and without increased cardiotoxicity.
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedAcute myeloid leukaemia
InterventionAddition of liposomal daunorubicin (DaunoXome®) to FLAG in reinduction course I.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Daunorubicin (DaunoXome®), fludarabine, ara-C, granulocyte colony-stimulating factor
Primary outcome measurePercentage of BM blasts greater than 20% after course I, determined 4 - 6 weeks after the start.
Secondary outcome measures1. Toxicity, focusing on but not limited to bone marrow aplasia, mucosal toxicity and cardiotoxicity
2. Efficacy as determined by day 14 BM blasts, time to PB clearance of blasts, CR rate after two courses of chemotherapy, % of patients that underwent SCT, overall survival, event-free survival and disease-free survival
3. Clinical and cell biological features, and overall outcome of the entire cohort of patients with relapsed AML that has been registered in the time period of patient accrual (also including patients that were not treated according to this protocol)
Overall study start date11/01/2001
Completion date11/01/2007

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit18 Years
SexBoth
Target number of participants400
Key inclusion criteria1. Primary refractory acutye myeloid leukaemia (AML)
2. First relapsed AML
3. Second or subsequent relapsed AML, but not previously treated according to protocol Relapsed AML 2001/01
4. Below 18 years of age at initial diagnosis
5. Signed informed consent
Key exclusion criteria1. Symptomatic cardiac dysfunction (CTC grade 3 or 4), and/or a fractional shortening at echocardiography below 29%
2. Karnofsky performance status less than 40% (children aged 16 years and older) or Lansky performance status of less than 40% (younger children)
3. Any other organ dysfunction (CTC grade 4) that will interfere with the protocol treatment
4. Inability to apply to the protocol for other reasons
5. AML FAB type M3, acute promyelocytic leukaemia, and/or t(1517) and/or PML-RARalfa fusion gene
Date of first enrolment11/01/2001
Date of final enrolment11/01/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Pediatric Oncology/Hematology
Amsterdam
1081 HV
Netherlands

Sponsor information

Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands)
Research organisation

Leyweg 299
Amsterdam
2545 CJ
Netherlands

Phone +31 (0)70 367 4545
Email info@skion.nl
Website http://www.skion.nl/
ROR logo "ROR" https://ror.org/01zs6bp63

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 10/02/2013 Yes No
Results article results 01/09/2014 Yes No