Clinical trial · Interventional
NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia
NCT00476541CI-TRIAL-00022158completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemtuzumab ozogamicin | Drug | Gemtuzumab Ozogamicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Gemtuzumab 5 mg / m2 two courses with three week interval
- interventionNames
- Drug: Gemtuzumab ozogamicin
- type
- NO_INTERVENTION
- label
- 2
- description
- No further therapy
Primary outcomes (1)
- measure
- Event free survival
- timeFrame
- 5 years
Secondary outcomes (1)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDLie 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. doi: 10.1038/sj.leu.2403962. PMID 16304571
- BACKGROUNDLie 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. doi: 10.1046/j.1365-2141.2003.04418.x. PMID 12846889
- DERIVEDHasle H, Abrahamsson J, Forestier E, Ha SY, Heldrup J, Jahnukainen K, Jonsson OG, Lausen B, Palle J, Zeller B; Nordic Society of Paediatric Haematology and Oncology (NOPHO). Gemtuzumab ozogamicin as postconsolidation therapy does not prevent relapse in children with AML: results from NOPHO-AML 2004. Blood. 2012 Aug 2;120(5):978-84. doi: 10.1182/blood-2012-03-416701. Epub 2012 Jun 22. PMID 22730539