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A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults
RATIONALE: 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. PURPOSE: 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.
Details
| Lead sponsor | Children's Oncology Group |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 1070 |
| Start date | 2006-08 |
| Completion | 2020-09-30 |
Conditions
- Leukemia
Interventions
- asparaginase
- cytarabine
- daunorubicin hydrochloride
- etoposide
- gemtuzumab ozogamicin
- mitoxantrone hydrochloride
Primary outcomes
- Event-free Survival at 3 Years — Time from study entry to time of induction failure, relapse, or death, assessed at 3 years
The Kaplan-Meier method will be used to calculate estimates of Event Free Survival (EFS). The log-rank test will be used to compare survival between treatment groups. Analysis of EFS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to Overall Survival (OS) and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\^2 (truncated at 3 standard deviations) and 2.5% type I error. - Overall Survival at 3 Years — Time from study entry, assessed at 3 years
The Kaplan-Meier method will be used to calculate estimates of OS. Analysis of OS of Down syndrome patients will be performed separately. Monitoring for efficacy of GMTZ with respect to OS and EFS will utilize monitoring based on the Lan-DeMets criterion with α-spending function αt\^2 (truncated at 3 standard deviations) and 2.5% type I error.
Countries
United States, Australia, Canada, New Zealand, Puerto Rico, Switzerland