Prevention of myeloid leukaemias in children with Down's syndrome and Transient Myeloproliferative Disorder
| ISRCTN | ISRCTN54575263 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54575263 |
| Protocol serial number | TMD Prevention 2007 |
| Sponsor | Hannover Medical School (Germany) |
| Funder | German Research Foundation (Deutsche Forschungsgemeinschaft [DFG]) (Germany) - (ref: RE 2580/1-1) |
- Submission date
- 30/05/2007
- Registration date
- 02/07/2007
- Last edited
- 17/02/2009
- 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
Dr Dirk Reinhardt
Scientific
Scientific
Pediatric Hematology/Oncology
Hannover Medical School
Carl-Neuberg-Str. 1
Hannover
30625
Germany
| reinhardt.dirk@mh-hannover.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, historically controlled trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study acronym | TMD Prevention 2007 |
| Study objectives | Elimination of the preleukaemic clone in children with Down's syndrome and Transient Myeloproliferative Disorder (TMD) to prevent Acute Myeloid Leukaemia (AML). As of 17/02/2009 this record was updated to include the following countries of recruitment: Netherlands, Czech Republic, Slovakia. |
| Ethics approval(s) | Approved by the Ethical Committee of the Hannover Medical School on the 17th November 2006 (ref: 4378M). |
| Health condition(s) or problem(s) studied | Transient myeloproliferative disorder in children with Down's syndrome |
| Intervention | Experimental intervention: Monitoring of GATA1s positive preleukemic clones, low-dose cytarabine treatment in children with persisting GATA1s clone. Control intervention: None, historical controls are used. Duration of intervention per patient: three months |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cytarabine |
| Primary outcome measure(s) |
Reduction of Down's Syndrome Myeloid Leukaemia (DS-ML) risk in children with TMD from 22% to 7%. |
| Key secondary outcome measure(s) |
1. Key secondary endpoint: GATA1s negativity (sensitivity 10-3/-4) at week 12 |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | TMD with GATA1s mutation and myeloproliferation (greater than 5% blasts in peripheral blood or bone marrow). |
| Key exclusion criteria | 1. No consent 2. No trisomy 21 |
| Date of first enrolment | 01/05/2007 |
| Date of final enrolment | 30/04/2012 |
Locations
Countries of recruitment
- Czech Republic
- Germany
- Netherlands
- Slovakia
Study participating centre
Pediatric Hematology/Oncology
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? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
