NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
N/A
18 Years
Both
Pediatric Acute Myeloblastic Leukemia
Trial Information
NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
Inclusion Criteria:
1. AML as defined by the WHO diagnostic criteria
2. Age < 19 years at time of diagnosis
3. Written informed consent
Exclusion Criteria:
1. Previous chemotherapy or radiotherapy. This includes patient with secondary AML after
previous cancer therapy
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
11. Lactating female or female of childbearing potential not using adequate contraception
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Minimal residual disease
Outcome Description:
MRD will be measured by flow cytometry. In the randomisation for course 1 the endpoint is at day 22. In the randomisation for course 2 the endpoint is immediately before start of consolidation
Outcome Time Frame:
On day 22 after the first induction and after second induction
Safety Issue:
No
Principal Investigator
Jonas Abrahamsson, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Children's Cancer Centre, Queen Silvias Childrens and Adolescents Hospital 416 85 Gothenburg, Sweden
Authority:
Sweden: Medical Products Agency
Study ID:
NOPHO-DBH-AML2012
NCT ID:
NCT01828489
Start Date:
March 2013
Completion Date:
March 2023
Related Keywords:
- Pediatric Acute Myeloblastic Leukemia
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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