Acute Myeloid Leukemia Clinical Trial
Official title:
NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia
Verified date | May 2015 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: National Board of Health |
Study type | Interventional |
The overall objective is to improve the cure rate of children with newly diagnosed acute
myeloid leukemia (AML) who undergo risk-adapted therapy.
Stem cell transplantation (SCT) is reserved to high-risk patients defined by cytogenetics
and response to chemotherapy. The efficacy and toxicity of Gemtuzumab ozogamicin (GO,
Mylotarg) will be evaluated.
Status | Completed |
Enrollment | 250 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - AML as defined by the diagnostic criteria, - Age < 19 years at time of study entry, - Written informed consent Exclusion Criteria: - Previous chemo- or radiotherapy, - AML secondary to previous bone marrow failure syndrome, - Down syndrome (DS), - Acute promyelocytic leukemia (APL), - Juvenile myelomonocytic leukemia (JMML), - Myelodysplastic syndrome (MDS), - Fanconi anemia, - Positive pregnancy test |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Pediatrics, Aarhus University Hospital Skejby | Aarhus | |
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Lie SO, Abrahamsson J, Clausen N, Forestier E, Hasle H, Hovi L, Jonmundsson G, Mellander L, Gustafsson G. Treatment stratification based on initial in vivo response in acute myeloid leukaemia in children without Down's syndrome: results of NOPHO-AML trials. Br J Haematol. 2003 Jul;122(2):217-25. — View Citation
Lie SO, Abrahamsson J, Clausen N, Forestier E, Hasle H, Hovi L, Jonmundsson G, Mellander L, Siimes MA, Yssing M, Zeller B, Gustafsson G; Nordic Society of Pediatric Hematology and Oncology (NOPHO); AML Study Group. Long-term results in children with AML: NOPHO-AML Study Group--report of three consecutive trials. Leukemia. 2005 Dec;19(12):2090-100. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event free survival | 5 years | No | |
Secondary | Overall survival | 5 years | No |
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