Clinical trial · Interventional
HDAC Inhibitor Valproic Acid as an Effective Therapy for Chronic Lymphocytic Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to poor accrual.
Summary
Brief summary (as posted)
OBJECTIVES To investigate: * the mechanism of Valproic Acid (VPA)-induced apoptosis in B-CLL * the ability of VPA in combination with standard chemotherapy or new antitumor agents to induce a synergistic antitumor effect in chronic lymphocytic leukemia (CLL) cells * the clinical efficacy of VPA in previously treated CLL patients. This will be an example of a translational research study where the results of our laboratory studies will be applied to a clinical trial in the CLL clinic at CancerCare Manitoba.
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 & fludarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Valproic acid & fludarabine
Primary outcomes (1)
- measure
- Best clinical response as defined by NCIWG criteria for CLL
- timeFrame
- 6 months after commencing therapy
Secondary outcomes (1)
- measure
- Effect of treatment on histone acetylation status; hematological toxicity (graded according to NCIWG criteria for CLL) and nonhematological toxicity (graded according to NCI common toxicity criteria)
- timeFrame
- throughout therapy
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. * Recruitment will be limited to those with an ECOG performance status of 2 or less. Exclusion Criteria: * Patients who are pregnant or breastfeeding * Patients with a history of autoimmune cytopenias * Patients with platelets \< 50 x 109/L or an absolute neutrophil count \< 1.5X109/L * Patients with hepatic disease or an AST/ALT 6x above the upper limit of normal * Patients with a calculated creatinine clearance \< 30 ml/min using the Cockroft and Gault formula * Patients with a history of pancreatitis * Patients who are receiving drugs that affect VPA protein binding or metabolism * Patients with active infection, HIV or active viral hepatitis * Patients with active secondary malignancy or who have central nervous system involvement with CLL * Patients diagnosed with more an aggressive lymphoproliferative disorder such as Richter's transformation
References
Publications (0)
Data not yet available