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ClinicalTrials.gov ID

NCT01828489

Lead Sponsor

Vastra Gotaland RegionOTHER_GOV

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

300Estimated

Last Update Posted

Jan 10, 2017Estimated

Start Date

Mar 2013

Primary Completion Date

Mar 2018Estimated

Completion Date

Mar 2023Estimated

Official Title

NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years

Brief 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).

• Pediatric Acute Myeloblastic Leukemia

• Randomisation course 1 mitoxantrone versus DaunoXome
• Randomisation course 2 ADxE versus FLADx

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Factorial Assignment

Masking

None (Open Label)

Lead Sponsor

Vastra Gotaland RegionOTHER_GOV

marie.francoise.dresse@chrcitadelle.be+32 42238980