Myeloid leukaemia of down syndrome Cancer Myeloid leukaemia
Conditions
Interventions
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
Sponsors
University of Münster (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Event free survival 2. Overall survival Measured at days 1, 28, 42 - 56 and 88. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of toxicity, measured at days 1, 28, 42 - 56 and 88. | — |
Countries
Czech Republic, Denmark, France, Germany, Netherlands, Norway, Slovakia, Sweden
Outcome results
None listed