Clinical trial · Interventional
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
NCT01011998CI-TRIAL-00005547withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to lack of accrual per Center DSMP, with PI concurrence
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gleevec (imatinib), valproic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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.
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.