Study:
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.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Leukemia |
Drug: asparaginase
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: etoposide
Drug: gemtuzumab ozogamicin
Drug: mitoxantrone hydrochloride |
Phase 3 |
Verified by
Children`s Oncology Group
November, 2010
Sponsored by: Children`s Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00372593
Study Type: Interventional
Study Design: Allocation: Randomized, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Alan S. Gamis, MD, MPH., Study Chair
Richard Aplenc, MD, MSCE.,