NCT01011998

A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)

A Phase II Study of Imatinib and Valproic Acid in Patients With CML

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Gleevec (imatinib), valproic acid	Valproic acid: 250 mg three times per day and then adjusted according to attain a therapeutic level. Gleevec will be continued at the dose the patient was taking at the time of entry onto the study.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2009-11-11
• Last updated: 2011-09-27

Locations

1 site across 1 country: United States