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NCT00492856 (Clinical Trial / Gemtuzumab Ozogamicin)

Study Title
S0521, Combination Chemotherapy With or Without Gemtuzumab Followed By Tretinoin, Mercaptopurine, and Methotrexate or Observation in Treating Patients With Acute Promyelocytic Leukemia (NCT00492856)

Trial Description
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 the antibody-drug conjugate or ADC gemtuzumab ozogamicin (Mylotarg®; Pfizer/Wyeth-Ayerst Laboratories), 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.

This randomized phase III trial is studying tretinoin (Atralin®; Valeant Pharmaceuticals), mercaptopurine (Purixan®; Rare Disease Therapeutics), and methotrexate (Trexall®; Teva Pharmaceuticalsto 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) 

This trial is sponsored by Southwestern Oncology GroupNational Cancer Institute (NCI). [1]

Study Data

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Last Editorial review: July 24, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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