Trials / Unknown
UnknownNCT01828489
Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Vastra Gotaland Region · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the effect of different induction courses in children and adolescents with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In the second course patients are randomised between standard treatment with ADxE (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine, DaunoXome).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Randomisation course 1 mitoxantrone versus DaunoXome | In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline. |
| DRUG | Randomisation course 2 ADxE versus FLADx | The second course is randomised to either ADxE (standard arm) or FLADx |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2018-03-01
- Completion
- 2023-03-01
- First posted
- 2013-04-10
- Last updated
- 2017-01-10
Locations
32 sites across 9 countries: Belgium, Denmark, Estonia, Finland, Hong Kong, Iceland, Netherlands, Norway, Sweden
Source: ClinicalTrials.gov record NCT01828489. Inclusion in this directory is not an endorsement.