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

Launched by NEW MEXICO CANCER RESEARCH ALLIANCE · Nov 10, 2009

Keywords

ClinConnect 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. 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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All patients, 18 years of age or older, with a diagnosis of CML.
• • Patients must have a life expectancy of at least 12 weeks.
• • Patients must have an ECOG performance status of 0-2.
• • Patients must sign an informed consent.
• • Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal.
• * Patients with CML in chronic phase on imatinib as first line therapy who fulfill the following criteria:
• • The patient has at least two tests for quantitative reverse transcriptase polymerase chain reaction (RT-PCR) for bcr-abl (peripheral blood or bone marrow aspirate). The results of these tests should demonstrate a relative plateau in the effect of imatinib on the detected level of the transcript (i.e. there should less than a ½ log difference between the last two values). Note: Patients will be eligible if the more recent study is greater than the previous study by any value.
• • The last two quantitative RT-PCR studies should be at least 3 months apart.
• • The patient should have received at least 9 months of imatinib since the diagnosis of CML.
• • The patient is tolerating imatinib without any grade 3 or greater toxicity.
• Exclusion Criteria:
• • Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
• • Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
• • Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
• • Patients who have a hypersensitivity to valproic acid, derivatives, or any component of the formulation. Patients with hepatic disease or significant impairment, or urea cycle disorders