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A Phase II Study of Subcutaneous Bortezomib as Maintenance Therapy for Patients With High-risk Acute Myeloid Leukemia in Remission
This phase II trial studies how well bortezomib works in treating patients with high-risk acute myeloid leukemia (AML) in remission. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
PRIMARY OBJECTIVES: I. To determine if bortezomib when given as maintenance therapy for six months post-remission can improve the progression-free survival (PFS) rate by 50% (or 4.5 months) in first remission patients with high-risk AML. SECONDARY OBJECTIVES: I. To determine the overall survival (OS) after maintenance therapy with bortezomib in first remission AML patients. II. To assess the safety and tolerability of subcutaneous (SC) administration of bortezomib given as maintenance therapy to first remission AML patients. OUTLINE: Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 2 years, and then annually for 3 years.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Start Date
November 1, 2011
Primary Completion Date
January 28, 2014
Completion Date
March 2, 2015
Last Updated
April 4, 2017
6
ACTUAL participants
bortezomib
DRUG
Lead Sponsor
Fred Hutchinson Cancer Center
Collaborators
NCT00352365
NCT01235572
Data Source & Attribution
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