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
Scientific
Pediatric Oncology/Hematology
Vrije University Medical Center
De Boelelaan 1117
Amsterdam
1081 HV
Netherlands
Phone | +31 (0)20 4442420 |
---|---|
gjl.kaspers@vumc.nl |
Study information
Study design | Multicentre, randomised, active controlled, parallel group trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | Relapsed AML 2001/01 |
Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Acute myeloid leukaemia |
Intervention | Addition of liposomal daunorubicin (DaunoXome®) to FLAG in reinduction course I. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Daunorubicin (DaunoXome®), fludarabine, ara-C, granulocyte colony-stimulating factor |
Primary outcome measure | 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 study start date | 11/01/2001 |
Completion date | 11/01/2007 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Child |
Upper age limit | 18 Years |
Sex | Both |
Target number of participants | 400 |
Key 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 |
Key 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 |
Date of first enrolment | 11/01/2001 |
Date of final enrolment | 11/01/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Pediatric Oncology/Hematology
Amsterdam
1081 HV
Netherlands
1081 HV
Netherlands
Sponsor information
Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands)
Research organisation
Research organisation
Leyweg 299
Amsterdam
2545 CJ
Netherlands
Phone | +31 (0)70 367 4545 |
---|---|
info@skion.nl | |
Website | http://www.skion.nl/ |
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |