A phase 2 trial of azacitidine and gemtuzumab ozogamicin therapy in older patients with acute myeloid leukemia Journal Article

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Authors: Nand, S; Othus, M.; Godwin, J. E.; Willman, C. L.; Norwood, T. H.; Howard, D. S.; Coutre, S. E.; Erba, H. P.; Appelbaum, F. R.
Article Title: A phase 2 trial of azacitidine and gemtuzumab ozogamicin therapy in older patients with acute myeloid leukemia
Abstract: This trial tested the safety and efficacy of a regimen consisting of hydroxyurea followed by azacitidine, 75 mg/m(2) for 7 days, and gemtuzumab ozogamicin, 3 mg/m(2) on day 8, in older patients with newly diagnosed acute myeloid leukemia. Those achieving a complete remission received 1 consolidation treatment followed by 4 cycles of azacitidine. The patients were stratified into good-risk (age 60-69 years or performance status 0-1) and poor-risk (age >/=70 years and performance status 2 or 3) groups. Specific efficacy and safety goals were defined as being supportive of further study of the regimen. Eighty-three patients were registered in the good-risk cohort and 59 in poor-risk cohort, with median age of 71 and 75 years, respectively. In the good-risk group, 35 patients (44%) achieved a complete remission. Median relapse-free and overall survivals were 8 and 11 months, respectively. Six patients (8%) died within 30 days of registration. In the poor-risk group, 19 (35%) achieved a complete remission. Median relapse-free and overall survivals were 7 and 11 months, respectively. Seven patients (14%) died early. The results of this trial met predefined goals for efficacy and safety for the poor-risk cohort but not the good-risk group. .
Journal Title: Blood
Volume: 122
Issue: 20
ISSN: 1528-0020; 0006-4971
Publisher: American Society of Hematology  
Journal Place: United States
Date Published: 2013
Start Page: 3432
End Page: 3439
Language: eng
DOI/URL:

10.1182/blood-2013-06-506592
Notes: LR: 20141116; ClinicalTrials.gov/NCT00658814; GR: CA11083/CA/NCI NIH HHS/United States; GR: CA12644/CA/NCI NIH HHS/United States; GR: CA14028/CA/NCI NIH HHS/United States; GR: CA16385/CA/NCI NIH HHS/United States; GR: CA27057/CA/NCI NIH HHS/United States; GR: CA32102/CA/NCI NIH HHS/United States; GR: CA35176/CA/NCI NIH HHS/United States; GR: CA35178/CA/NCI NIH HHS/United States; GR: CA35261/CA/NCI NIH HHS/United States; GR: CA35431/CA/NCI NIH HHS/United States; GR: CA38926/CA/NCI NIH HHS/United States; GR: CA45377/CA/NCI NIH HHS/United States; GR: CA45807/CA/NCI NIH HHS/United States; GR: CA45808/CA/NCI NIH HHS/United States; GR: CA46136/CA/NCI NIH HHS/United States; GR: CA46282/CA/NCI NIH HHS/United States; GR: CA46441/CA/NCI NIH HHS/United States; GR: CA58882/CA/NCI NIH HHS/United States; GR: CA63848/CA/NCI NIH HHS/United States; GR: CA67575/CA/NCI NIH HHS/United States; GR: CA86780/CA/NCI NIH HHS/United States; JID: 7603509; 0 (Aminoglycosides); 0 (Antibodies, Monoclonal, Humanized); 0 (gemtuzumab); M801H13NRU (Azacitidine); X6Q56QN5QC (Hydroxyurea); OID: NLM: PMC3829116; 2013/10/03 [aheadofprint]; ppublish