relapsed acute myeloid leukemia
Conditions
Interventions
All patients eligible for this study will be randomised in a 1:1 fashion for
the addition or not of GO (Mylotarg®) at 4.5 mg/m2 to DX-FLA in the first
course of reinduction chemotherapy. If GO at 4.
Sponsors
Stichting Kinderoncologie Nederland
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Children and adolescents
Exclusion criteria
Exclusion criteria: 1. FAB type M3 (please refer to your local group for the appropriate treatment protocol) 2. Myeloid Leukemia of Down syndrome (please refer to your local group for treatment alternatives) 3. Symptomatic cardiac dysfunction (CTC grade 3 or 4) and/or a Fractional Shortening at echocardiography below 29% 4. A Karnofsky performance status than NCI-CTC grade 1 (max 2.0 x ULN for transaminases and bilirubin) 7. History of veno-occlusive disease (VOD) 8. Hypersensitivity to gemtuzumab ozogamicin 9. Inability to potentially complete the treatment protocol for any other reason 10. Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone marrow blasts on *day 28* (before the start of the second reinduction course) given as * 20% or >20%. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. overall survival 2. event-free survival 3. Percentage of patients that achieve CR after two courses of reinduction chemotherapy 4. Incidence of treatment related mortality and toxicity according to NCI-CTC criteria | — |
Countries
Netherlands
Outcome results
None listed