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Sponsored by: |
University of Aarhus |
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Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00476541 |
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 | Intervention | Phase |
---|---|---|
Acute Myeloid Leukemia |
Drug: Gemtuzumab ozogamicin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 250 |
Study Start Date: | January 2004 |
Estimated Study Completion Date: | January 2014 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Gemtuzumab 5 mg / m2 two courses with three week interval
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Drug: Gemtuzumab ozogamicin |
2: No Intervention
No further therapy
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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
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Henrik Hasle, MD | +45 8949 6716 | hasle@dadlnet.dk |
Denmark | |
Department of Pediatrics, Aarhus University Hospital Skejby | Recruiting |
Aarhus, Denmark, 8200 | |
Principal Investigator: Henrik Hasle, MD | |
Rigshospitalet | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Birgitte Lausen, MD | |
Principal Investigator: Birgitte Lausen, MD |
Study Chair: | Henrik Hasle, MD | Department of Pediatrics, Aarhus University Hospital Skejby, Aarhus, Denmark |
Study ID Numbers: | NOPHO-AML 2004 |
Study First Received: | May 21, 2007 |
Last Updated: | July 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00476541 |
Health Authority: | Denmark: National Board of Health |
AML Children Gemtuzumab ozogamicin Stem cell transplantation |
Antibodies, Monoclonal Leukemia Antibodies Acute myelogenous leukemia Leukemia, Myeloid |
Gemtuzumab Leukemia, Myeloid, Acute Acute myelocytic leukemia Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |