Clinical Trials Directory

Trials / Terminated

TerminatedNCT01465386

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

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

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
6 (actual)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DRUGbortezomibGiven SC

Timeline

Start date
2011-11-01
Primary completion
2014-01-28
Completion
2015-03-02
First posted
2011-11-04
Last updated
2017-04-04
Results posted
2017-04-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01465386. Inclusion in this directory is not an endorsement.