Protocol for treatment of children and adolescents with acute myeloid leukemia 0-18 years
Phase 3
Recruiting
- Conditions
- bloodcancerleukemia10024324
- Registration Number
- NL-OMON55459
- Lead Sponsor
- Västra Götalandregionen, Queen Silvias Childrens and Adolescents Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
Patients are eligible for the study if they fulfil all three criteria below, 1)
AML as defined by the diagnostic criteria in section 16
2) Age < 19 years at time of diagnosis
3) Written informed consent
Exclusion Criteria
Patients are excluded if any of the criteria below are present
1) Previous chemotherapy or radiotherapy.
2) AML secondary to previous bone marrow failure syndrome.
3) Down syndrome (DS).
4) Acute promyelocytic leukaemia (APL).
5) Myelodysplastic syndrome (MDS).
6) Juvenile Myelomonocytic Leukaemia (JMML).
7) Known intolerance to any of the chemotherapeutic drugs in the protocol.
8) Fanconi anaemia.
9) Major organ failure precluding administration of planned chemotherapy.
10) Positive pregnancy test.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the MRD level at day 22 from start of the course. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures in both studies include EFS, OS, remission rate and<br /><br>toxicity.</p><br>