Clinical Trial: Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase II Study of Subcutaneous Bortezomib as Maintenance Therapy for Patients With High-risk Acute Myeloid Leukemia in Remission

Brief Summary: 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

Detailed Summary:

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.


Sponsor: Fred Hutchinson Cancer Research Center

Current Primary Outcome: Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]

Number of days from enrollment to recurrence of acute myeloid leukemia as determined by the reappearance of blasts in the blood or marrow


Original Primary Outcome: PFS after bortezomib maintenance therapy among patients with AML in remission [ Time Frame: Up to 2 years ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Fred Hutchinson Cancer Research Center

Dates:
Date Received: October 10, 2011
Date Started: November 2011
Date Completion:
Last Updated: February 17, 2017
Last Verified: February 2017