Spots Global Cancer Trial Database for NOPHO-AML 2004 Study for Children With Acute Myeloid Leukemia

Study Description

Brief Summary: 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.

Detailed Description: 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

Keywords

Eligibility

Minimum Age: 1 Day

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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