NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00476541|
Recruitment Status : Completed
First Posted : May 22, 2007
Last Update Posted : May 13, 2016
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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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Gemtuzumab ozogamicin||Phase 3|
The overall objective is to improve the cure rate of pediatric patients with newly diagnosed acute myeloid leukemia (AML). The specific aims are as follows:
1.1 Therapeutic aims
To improve the event-free survival (EFS) of AML patients who undergo risk-adapted therapy.
To improve the overall survival (OS) by reserving stem cell transplantation (SCT) to high-risk patients based on cytogenetics and response to induction therapy.
To compare the outcome of SCT using HLA-matched sibling donor (MSD) or HLA-matched unrelated donor (MUD).
To assess the efficacy and toxicity of Gemtuzumab ozogamicin (GO, Mylotarg) as post consolidation therapy.
1.2 Biologic aims
To study minimal residual disease (MRD) levels in blood and bone marrow (BM) at defined time points and to study the prognostic impact of MRD.
To test in vitro cellular drug resistance at diagnosis and relapse, and correlate these data to background factors and clinical outcome.
To secure storage of biological material from diagnosis for future biologic studies
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia|
|Study Start Date :||January 2004|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Gemtuzumab 5 mg / m2 two courses with three week interval
Drug: Gemtuzumab ozogamicin
Two courses of Gemtuzumab vs. no further therapy
Other Name: Mylotarg
No Intervention: 2
No further therapy
- Event free survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
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|Ages Eligible for Study:||1 Day to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- AML as defined by the diagnostic criteria,
- Age < 19 years at time of study entry,
- Written informed consent
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476541
|Department of Pediatrics, Aarhus University Hospital Skejby|
|Aarhus, Denmark, 8200|
|Copenhagen, Denmark, 2100|
|Study Chair:||Henrik Hasle, MD||Department of Pediatrics, Aarhus University Hospital Skejby, Aarhus, Denmark|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||University of Aarhus|
|Other Study ID Numbers:||
|First Posted:||May 22, 2007 Key Record Dates|
|Last Update Posted:||May 13, 2016|
|Last Verified:||May 2015|
Stem cell transplantation
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents, Immunological
Physiological Effects of Drugs