Clinical Trial: Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics

Brief Summary: This research is being done because treatment options are very limited and usually unsuccessful for Acute Myeloid Leukemia (AML) in older individuals, or younger people with disease that has relapsed and/or proven resistant to standard therapy. Subjects are invited to participate in this study that will examine the use of three drugs called Sorafenib (Nexavar), Vorinostat (Zolinza) and Bortezomib (Velcade) for treating acute myeloid leukemia.

Detailed Summary:
Sponsor: Hamid Sayar

Current Primary Outcome: Number of dose limiting toxicities (DLTs) after administration of sorafenib, vorinostat and bortezomib [ Time Frame: up to 9 months of treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of patients with a partial response or greater to the combination of sorafenib, vorinostat and bortezomib [ Time Frame: up to 9 months of treatment ]
  • Duration to relapse in patients who experience relapse following achievement of a complete remission [ Time Frame: approximately 1 year after achieving complete remission ]
    This is defined as the duration of remission from the time of documentation of complete morphologic remission to the time of documentation of relapse.


Original Secondary Outcome: Number of patients with a partial response or greater to the combination of sorafenib, vorinostat and bortezomib [ Time Frame: up to 9 months of treatment ]

Information By: Indiana University

Dates:
Date Received: February 13, 2012
Date Started: February 10, 2012
Date Completion: December 31, 2017
Last Updated: January 30, 2017
Last Verified: January 2017