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Cytarabine and Daunorubicin With or Without Gemtuzumab Ozogamicin Followed By High-Dose Cytarabine Followed By Either Gemtuzumab Ozogamicin or No Additional Therapy in Treating Patients With Previously Untreated De Novo Acute Myeloid Leukemia


A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg®) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg®) or No Additional Therapy For Patients Under Age 56 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)


Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop cancer cells from dividing so they stop growing and die. Monoclonal antibodies, such as gemtuzumab ozogamicin, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy with gemtuzumab ozogamicin may kill more cancer cells. It is not yet known whether induction therapy using cytarabine and daunorubicin is more effective with or without gemtuzumab ozogamicin or whether postconsolidation therapy using gemtuzumab ozogamicin is more effective than no additional therapy in treating de novo (first occurrence) acute myeloid leukemia.


This randomized phase III trial is comparing two different regimens of chemotherapy and monoclonal antibody therapy to see how well they work in treating patients with previously untreated de novo acute myeloid leukemia.

Study Status: Recruiting

Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100

Condition Intervention Phase
Leukemia Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: filgrastim
Drug: gemtuzumab ozogamicin
Drug: sargramostim
Procedure: observation
Phase 3

Verified by Southwest Oncology Group November, 2008

Sponsored by: Southwest Oncology Group
Information provided by: National Cancer Institute (NCI) identifier: NCT00085709

Study Type: Interventional

Study Design: Treatment, Randomized, Active Control

Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States

Stephen H. Petersdorf, MD.,

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