Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
28/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gertjan J.L. Kaspers

ORCID ID

Contact details

Pediatric Oncology/Hematology
Vrije University Medical Center
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
+31 (0)20 4442420
gjl.kaspers@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR136

Study information

Scientific title

Acronym

Relapsed AML 2001/01

Study hypothesis

Addition 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

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute myeloid leukaemia

Intervention

Addition of liposomal daunorubicin (DaunoXome®) to FLAG in reinduction course I.

Intervention type

Drug

Phase

Not Specified

Drug names

Daunorubicin (DaunoXome®), fludarabine, ara-C, granulocyte colony-stimulating factor

Primary outcome measures

Percentage of BM blasts greater than 20% after course I, determined 4 - 6 weeks after the start.

Secondary outcome measures

1. 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 trial start date

11/01/2001

Overall trial end date

11/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. 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

Recruitment start date

11/01/2001

Recruitment end date

11/01/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Pediatric Oncology/Hematology
Amsterdam
1081 HV
Netherlands

Sponsor information

Organisation

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

Sponsor details

Leyweg 299
Amsterdam
2545 CJ
Netherlands
+31 (0)70 367 4545
info@skion.nl

Sponsor type

Research organisation

Website

http://www.skion.nl/

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23319696
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24763401

Publication citations

  1. Results

    Kaspers GJ, Zimmermann M, Reinhardt D, Gibson BE, Tamminga RY, Aleinikova O, Armendariz H, Dworzak M, Ha SY, Hasle H, Hovi L, Maschan A, Bertrand Y, Leverger GG, Razzouk BI, Rizzari C, Smisek P, Smith O, Stark B, Creutzig U, Improved outcome in pediatric relapsed acute myeloid leukemia: results of a randomized trial on liposomal daunorubicin by the International BFM Study Group., J. Clin. Oncol., 2013, 31, 5, 599-607, doi: 10.1200/JCO.2012.43.7384.

  2. Results

    Creutzig U, Zimmermann M, Dworzak MN, Gibson B, Tamminga R, Abrahamsson J, Ha SY, Hasle H, Maschan A, Bertrand Y, Leverger G, von Neuhoff C, Razzouk B, Rizzari C, Smisek P, Smith OP, Stark B, Reinhardt D, Kaspers GL, The prognostic significance of early treatment response in pediatric relapsed acute myeloid leukemia: results of the international study Relapsed AML 2001/01., Haematologica, 2014, 99, 9, 1472-1478, doi: 10.3324/haematol.2014.104182.

Additional files

Editorial Notes