Myeloid Leukaemia Down Syndrome 2006 for the treatment of myeloid leukaemia in children with Down syndrome
Completed
- Conditions
- Myeloid leukaemia of down syndromeCancerMyeloid leukaemia
- Registration Number
- ISRCTN41024033
- Lead Sponsor
- niversity of Münster (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Event free survival<br>2. Overall survival<br><br>Measured at days 1, 28, 42 - 56 and 88.
- Secondary Outcome Measures
Name Time Method Reduction of toxicity, measured at days 1, 28, 42 - 56 and 88.