Study:
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)
Rationale:
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.
Purpose:
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
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)
ClinicalTrials.gov 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.,