Phase 2 Trial of R115777 in Previously Untreated Older Adults With AML and Baseline Presence of a Specific 2-Gene Expression Signature Ratio
This study will test the ability of a newly developed screening test, the RASGRP1:aprataxin
(APTX) ratio, to identify patients who are more likely to benefit from R115777 therapy.
RASGRP1 and APTX are genes that are expressed in leukemia cells. This test is performed on a
sample of bone marrow tissue, and determines the ratio of RASGRP1 and APTX expression in the
bone marrow. Ratios that are C5 are will be considered as a positive result, and these
patients will be eligible for treatment with R115777. The ratio of C5 is expected to be
found in about 30% of patients. This screening test is still considered an experimental
procedure.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants with Complete Remission
To determine the complete remission (CR) rate in AML patients prospectively selected for R115777R115777 (ZARNESTRA) treatment on the basis of a 2-gene signature (RASGRP1:APTX ratio) in bone marrow aspirates. Patients will be periodically followed after their completion of the study to collect information on subsequent therapies and survival data.
From first treatment through follow up period, an expected average of 12 months
No
Jeffrey Lancet, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute
United States: Food and Drug Administration
NCI # 8977
NCT01361464
May 2011
June 2014
Name | Location |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
University of Maryland Medical Center | Baltimore, Maryland 21201-1595 |
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center | Baltimore, Maryland 21231 |
Emory - Winship Cancer Institute | Atlanta, Georgia 30322 |
Cornell - Weill Medical College of Cornell University | New York, New York 10065 |
UNC-Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina 27599 |