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

Chronic Myelogenous Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01011998
• Other study ID #: INST 0901
• Status: Withdrawn
• Phase: Phase 2
• First received: November 5, 2009
• Last updated: September 23, 2011
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2011
• Source: New Mexico Cancer Care Alliance
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Myelogenous Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
New Mexico Cancer Care Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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