Myeloid Leukaemia Down Syndrome 2006 for the treatment of myeloid leukaemia in children with Down syndrome
| ISRCTN | ISRCTN41024033 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41024033 |
| Protocol serial number | N/A |
| Sponsor | University of Münster (Germany) |
| Funder | German Cancer Aid (Deutsche Krebshilfe) (Germany) |
- Submission date
- 17/02/2009
- Registration date
- 19/03/2009
- Last edited
- 19/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Dirk Reinhardt
Scientific
Scientific
Carl-Neuberg-Str. 1
Hannover
30625
Germany
| reinhardt.dirk@mh-hannover.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre open-label non-randomised trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Myeloid Leukaemia Down Syndrome 2006 for the treatment of myeloid leukaemia in children with Down syndrome: a multicentre, open-label, non-randomised trial with direct individual benefit |
| Study acronym | ML-DS 2006 |
| Study objectives | 1. Standardisation of treatment for all children with Down syndrome (DS) and myeloid leukaemia (ML) 2. Achievement of an overall survival of 85% in all participating institutions 3. Optimisation of the quality of supportive therapy 4. Establishment of an international network of coordinated research in ML and DS |
| Ethics approval(s) | 1. Ethics committee of the University of Münster gave approval on 29th March 2007 (ref: 3VCreutzig 10) 2. Ethics committee of the Hannover Medical School gave approval on the 24th May 2007 (ref: 4378M) |
| Health condition(s) or problem(s) studied | Myeloid leukaemia of down syndrome |
| Intervention | Four elements of polychemotherapy: Course 1: Cytarabine 100 mg/m^2/day on days 1 and 2 Cytarabine 100 mg/m^2/12 hours on days 3 - 8 Idarubicin 8 mg/m^2/day on days 3, 5 and 7 Etoposide 150 mg/m^2/day on days 6, 7 and 8 Cytarabine intrathecal (i.th.) on day 1 Course 2: Cytarabine 500 mg/m^2/day on days 1 - 4 Idarubicin 5 mg/m^2/day on days 3 and 5 Cytarabine intrathecal (i.th.) on day 1 Course 3: High dose (HD) cytarabine 1 g/m^2/12 hours on days 1 - 3 Mitoxantrone 7 mg/m^2/day on days 3 and 4 Cytarabine intrathecal (i.th.) on day 1 Course 4: High dose (HD) cytarabine 3 g/m^2/12 hours on days 1 - 3 Cytarabine intrathecal (i.th.) on day 1 In children with a body weight less than or equal to 12 kg, the dosages are calculated according to body weight. After each course, a lumbar puncture and one marrow aspiration is performed at the following points: Course 1: day one Course 2: day 28 Course 3: days 42 - 56 Course 4: approximately day 88 The following information is collected: 1. Online documentation of treatment elements 2. Toxicity 3. Minimal residual disease |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Event free survival |
| Key secondary outcome measure(s) |
Reduction of toxicity, measured at days 1, 28, 42 - 56 and 88. |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 4 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Children with trisomy 21/trisomy 21 mosaic and myeloid leukaemia 2. Aged greater than 6 months to 4 years of age with/without GATA1 mutation, or aged greater than 4 years of age to 18 years of age with GATA1 mutation, either sex 3. Patients, in the above age group, must have DS and ML 4. Written informed consent |
| Key exclusion criteria | 1. Children without DS 2. Children with DS and transient myeloproliferative disorder (TMD) 3. Children with DS and acute lymphoblastic leukaemia (ALL) 4. Accompanying diseases which do not allow therapy according to the protocol 5. Pre-treatment greater than 14 days with intensive induction therapy |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Czech Republic
- Denmark
- France
- Germany
- Netherlands
- Norway
- Slovakia
- Sweden
Study participating centre
Carl-Neuberg-Str. 1
Hannover
30625
Germany
30625
Germany
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
