S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia
Completed · Phase 3
Conditions studied: Leukemia
In brief
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. Sometimes the cancer may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether combination chemotherapy is more effective than observation when given as maintenance therapy in treating acute promyelocytic leukemia. PURPOSE: This randomized phase III trial is studying tretinoin, mercaptopurine, and methotrexate to see how well they work when given as maintenance therapy compared with observation after combination chemotherapy in treating patients with acute promyelocytic leukemia. (Randomization and observation group closed as of 8/15/10)
Key facts
- Study ID
- NCT00492856
- Run by
- SWOG Cancer Research Network
- People needed
- 105
- Starts
- 2007-06-01
- Expected to finish
- 2016-05-04
- Last updated by the study team
- 2023-01-10
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Sutter Cancer Center at Roseville Medical Center — Roseville, California, United States
- Sutter Cancer Center — Sacramento, California, United States
- Stanford Cancer Center — Stanford, California, United States
- Tunnell Cancer Center at Beebe Medical Center — Lewes, Delaware, United States
- CCOP - Christiana Care Health Services — Newark, Delaware, United States
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Hematology Oncology Associates of Illinois - Berwyn — Berwyn, Illinois, United States
- Illinois CancerCare - Bloomington — Bloomington, Illinois, United States
- St. Joseph Medical Center — Bloomington, Illinois, United States
- Graham Hospital — Canton, Illinois, United States
- Illinois CancerCare - Canton — Canton, Illinois, United States
- Illinois CancerCare - Carthage — Carthage, Illinois, United States
- Memorial Hospital — Carthage, Illinois, United States
- Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
- Hematology and Oncology Associates — Chicago, Illinois, United States
- University of Chicago Cancer Research Center — Chicago, Illinois, United States
- Decatur Memorial Hospital Cancer Care Institute — Decatur, Illinois, United States
- Eureka Community Hospital — Eureka, Illinois, United States
- Illinois CancerCare - Eureka — Eureka, Illinois, United States
- Galesburg Clinic, PC — Galesburg, Illinois, United States
- Illinois CancerCare - Galesburg — Galesburg, Illinois, United States
- Illinois CancerCare - Havana — Havana, Illinois, United States
- Mason District Hospital — Havana, Illinois, United States
- Kellogg Cancer Care Center — Highland Park, Illinois, United States
- Mayo Clinic Scottsdale — Scottsdale, Arizona, United States
Full record on ClinicalTrials.gov
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