Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial
Official title:
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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