Clinical trial · Interventional
Study of Efficacy and Safety of Valproic Acid in Chronic Lymphocytic Leukemia (CLL)
Use of Valproic Acid in Relapsed or Refractory Chronic Lymphocytic Leukemia
NCT00810680CI-TRIAL-00001847unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether Valproic acid, as a single agent is effective in the treatment of Chronic Lymphocytic Leukemia which has relapsed or is refractory to therapy with standard drugs.
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 Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Valproic acid | Drug | Valproic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Valproic acid
- interventionNames
- Drug: Valproic acid
Primary outcomes (1)
- measure
- Best clinical response as defined by NCIWG criteria for CLL
- timeFrame
- 3 months
Secondary outcomes (2)
- measure
- Hematological toxicity (graded according to NCIWG criteria for CLL)
- timeFrame
- 3 months
- measure
- Non- hematological toxicity (graded according to NCI common toxicity criteria)
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Active CLL (as defined by the National Cancer Institute Working Group) * Patients must have received at least one prior therapy for CLL and have been treated with a nucleoside analogue. * Age 18 years or older. * Good general condition as defined by an Eastern cooperative oncology group- performance status (ECOG-PS) \</=2. * Absolute neutrophil count\>1500/cmm and platelet count \>30,000/cmm unless the low counts are due to the disease. * Adequate liver function (bilirubin\<2 mg/dL,ASTorALT \<3Xthe upper limit of normal) and renal function (serum creatinine\<2 mg/dL or creatinine clearance\>30 mL/min) unless abnormalities are as a result of disease involvement. * Full recovery from previous treatments. Exclusion Criteria: * Any therapy for CLL within 4 weeks before initiating treatment on this study. * Pregnancy.
References
Publications (1)
- BACKGROUNDBokelmann I, Mahlknecht U. Valproic acid sensitizes chronic lymphocytic leukemia cells to apoptosis and restores the balance between pro- and antiapoptotic proteins. Mol Med. 2008 Jan-Feb;14(1-2):20-7. doi: 10.2119/2007-00084.Bokelmann. PMID 17973028