Back to resultsA Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)
Primary Purpose
Chronic Myelogenous Leukemia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gleevec (imatinib), valproic acid
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myelogenous Leukemia focused on measuring CML, Chronic Myelogenous leukemia, INST 0901, imatinib, valproic acid, Gleevec
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
Sites / Locations
- University of New Mexico Cancer Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01011998
First Posted
November 5, 2009
Last Updated
September 23, 2011
Sponsor
New Mexico Cancer Care Alliance
1. Study Identification
Unique Protocol Identification Number
NCT01011998
Brief Title
A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)
Official Title
A Phase II Study of Imatinib and Valproic Acid in Patients With CML
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn due to lack of accrual per Center DSMP, with PI concurrence
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia
Keywords
CML, Chronic Myelogenous leukemia, INST 0901, imatinib, valproic acid, Gleevec
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Gleevec (imatinib), valproic acid
Other Intervention Name(s)
Valproic acid, Imatinib, Gleevec
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Rabinowitz, MD
Organizational Affiliation
University of New Mexico Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML)
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