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 |
| Protocol serial number | NTR136 |
| Sponsor | Dutch Childhood Oncology Group (Stichting Kinder Oncologie [SKION]) (The Netherlands) |
| Funder | Not provided at time of registration |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Daunorubicin (DaunoXome®), fludarabine, ara-C, granulocyte colony-stimulating factor |
| Primary outcome measure(s) |
Percentage of BM blasts greater than 20% after course I, determined 4 - 6 weeks after the start. |
| Key secondary outcome measure(s) |
1. Toxicity, focusing on but not limited to bone marrow aplasia, mucosal toxicity and cardiotoxicity |
| Completion date | 11/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
1081 HV
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
