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HDAC Inhibitor Valproic Acid as an Effective Therapy for Chronic Lymphocytic Leukemia

NCT00524667 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2011-07-20

No results posted yet for this study

Summary

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

Interventions

DRUG

Valproic acid & fludarabine

valproic acid (VPA) starting dose of 15 mg/day p.o. in divided doses, increased weekly by 5 mg/kg/day until \>1mM Fludarabine 40 mg/m2/day orally will be added after completing 28 days of VPA if participant has been identified as having stable or progressive disease.

Sponsors & Collaborators

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • CancerCare Manitoba

    lead OTHER

Principal Investigators

  • David Szwajcer, MD · CancerCare Manitoba / University of Manitoba

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00524667 on ClinicalTrials.gov