S0106 Cytarabine and Daunorubicin w/ or w/o Gemtuzumab Followed By HD Cytarabine and Either Gemtuzumab or Nothing in de Novo AML
Completed · Phase 3
Conditions studied: Leukemia
In brief
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.
Key facts
- Study ID
- NCT00085709
- Run by
- SWOG Cancer Research Network
- People needed
- 637
- Starts
- 2004-07-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2015-09-30
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Hembree Mercy Cancer Center at St. Edward Mercy Medical Center — Fort Smith, Arkansas, United States
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Alta Bates Summit Comprehensive Cancer Center — Berkeley, California, United States
- Peninsula Medical Center — Burlingame, California, United States
- Marin Cancer Institute at Marin General Hospital — Greenbrae, California, United States
- Sutter Health - Western Division Cancer Research Group — Greenbrae, California, United States
- USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
- California Pacific Medical Center - California Campus — San Francisco, California, United States
- Sutter Solano Medical Center — Vallejo, California, United States
- Center for Cancer Care and Research at Watson Clinic, LLP — Lakeland, Florida, United States
- Phoebe Cancer Center at Phoebe Putney Memorial Hospital — Albany, Georgia, United States
- Medical Center of Central Georgia — Macon, Georgia, United States
- Saint Anthony's Hospital at Saint Anthony's Health Center — Alton, Illinois, United States
- St. Joseph Medical Center — Bloomington, Illinois, United States
- Graham Hospital — Canton, Illinois, United States
- Memorial Hospital — Carthage, Illinois, United States
- Decatur Memorial Hospital Cancer Care Institute — Decatur, Illinois, United States
- Eureka Community Hospital — Eureka, Illinois, United States
- Galesburg Clinic, PC — Galesburg, Illinois, United States
- Galesburg Cottage Hospital — Galesburg, Illinois, United States
- Mason District Hospital — Havana, Illinois, United States
- Hopedale Medical Complex — Hopedale, Illinois, United States
- McDonough District Hospital — Macomb, Illinois, United States
- Cardinal Bernardin Cancer Center at Loyola University Medical Center — Maywood, Illinois, United States
- Providence Cancer Center — Anchorage, Alaska, United States
Full record on ClinicalTrials.gov
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