Current Research: Pediatric Hematology-Oncology

AAML0531 -- A Phase III Randomized Trial of Gemtuzumab Ozogamicin Combined with Conventional Chemotherapy for De Novo Acute Myeloid Leukemia in Children, Adolescents, and Young Adults

Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving combination chemotherapy together with gemtuzumab may kill more cancer cells. It is not yet known whether combination chemotherapy is more effective with or without gemtuzumab in treating patients with newly diagnosed acute myeloid leukemia.

This randomized phase III trial is studying combination chemotherapy and gemtuzumab to see how well they work compared with combination chemotherapy alone in treating young patients with newly diagnosed acute myeloid leukemia.

Eligibility

Patients may be eligible for this trial if:

• Children ≥ 1 month and children and young adults < 30 years of age with newly diagnosed AML
• Patients with cytopenias and bone marrow blasts who do not meet the customary criteria for the diagnosis of AML (patients with < 20% blasts) are eligible if they have a karyotypic abnormality characteristic of de novo AML (t(8;21)(q22;q22), inv(16)(p13q22) or t(16;16)(p13;q22) or 11q23 abnormalities), or if they have the unequivocal presence of megakaryoblasts
• Patients with isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis) are eligible
• Children who have previously received chemotherapy or radiation therapy or any antileukemic therapy are not eligible for this protocol. Exceptions include corticosteroids (any route), and IT cytarabine given at diagnosis.
• Children with documented myelodysplastic syndrome (MDS) (CMML, RA, RAEB, RARS, etc.) are only eligible if they present with karyotypic abnormalities of de novo AML (t(8;21)(q22;q22), inv(16)(p13q22) or t(16;16)(p13;q22) or 11q23 abnormalities), or if they have the unequivocal presence of megakaryoblasts

Trial Sponsor

• Children’s Oncology Group (COG); National Cancer Institute (NCI)

Project Begin Date

• May 2007

Tentative Project End Date

• Aug 2010

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Revised March 30, 2009.   Please send comments, suggestions or questions about this page to Goldei Posey, gposey@mcg.edu .