A Phase II Study of Imatinib and Valproic Acid in Patients With CML
The aim of this study is to test the effect of the combination of valproate in combination
with imatinib with an aim of achieving a maximal molecular response as the primary goal.
Briefly, patients with CML who are taking imatinib and have been found to have a plateau in
their level of the bcr-abl transcript will be eligible to participate in the study.
Valproate will then be added to the imatinib, and subsequent bcr-abl transcripts will be
monitored to see if the addition of valproate produced a further reduction. Patients will be
monitored for efficacy and toxicity.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To measure the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.
6 months
Yes
Ian Rabinowitz, MD
Principal Investigator
University of New Mexico Cancer Center
United States: Institutional Review Board
INST 0901
NCT01011998
September 2009
July 2010
Name | Location |
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University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |