A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML) - NCT01011998-87131 (Clinical Trial 400626)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy400626.aspx
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| City: |
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Albuquerque |
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State:
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NM |
| Zip Code: |
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87131 |
| Conditions: |
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Chronic Myelogenous Leukemia |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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 |
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| Study is available at: |
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University of New Mexico Cancer Center
Albuquerque, NM 87131
United States
Primary Contact:
Valerie Parks, RN
Email: vparks@salud.unm.edu
Phone: 505-272-0898
Secondary Contact:
Valerie Parks, RN
Phone: 505-272-0898 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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