Study of Efficacy and Safety of Valproic Acid in Chronic Lymphocytic Leukemia (CLL)

December 17, 2008 updated by: All India Institute of Medical Sciences, New Delhi

Use of Valproic Acid in Relapsed or Refractory Chronic Lymphocytic Leukemia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chronic lymphocytic leukemia (CLL) is a disease characterized by a prolonged clinical course. Though various drugs such as alkylating agents, antimetabolites such as fludarabine and targeted antibodies such as rituximab are effective against this condition, relapses are frequent and cure is rare. There exists a subset of CLL patients who are refractory to many of these first line agents. Though one or the other of the above mentioned class of drugs can be substituted for patients who have relapsed or have refractory disease, no therapy has been conclusively proven to have survival advantage in this condition. The costs and toxicities add to the burden of these therapies. Valproic acid is a well studied drug used for the treatment of epilepsy for over 30 years. It has a well documented side effect profile, is generally well tolerated and is inexpensive. Recently, it has been shown to be an inhibitor of the enzyme, Histone de-acetylase(HDAC). Inhibition of HDAC promotes apoptosis, and could lead to the death of CLL cells which harbor defective apoptotic mechanisms. In vitro studies have proven the ability of therapeutic concentrations of Valproic acid to achieve cell kill in cultures of CLL cells. This study aims to identify whether valproic acid, used in standard doses has single agent activity against CLL and to assess its tolerance in these patients.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Prasanth Ganesan, MD
  • Phone Number: 91-99681-47800
  • Email: pg1980@gmail.com

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Recruiting
        • Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vinod Raina, MD, FRCP
        • Sub-Investigator:
          • Prasanth Ganesan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Valproic acid
Drug: Valproic acid
Tab. Valproic acid will be started at a dose of 10 mg per kg per day in two or three divided doses. If well tolerated the dose will be increased to a maximum of 20 mg per kg per day and continued for a period of 3 months. The drug will be continued for another 3 months for a maximum of 6 months in responding patients. The drug will be stopped in all those who develop intolerable side effects or develop disease progression during therapy.
Other Names:
  • Depakote
  • Valproate
  • Sodium Valproate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best clinical response as defined by NCIWG criteria for CLL
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Hematological toxicity (graded according to NCIWG criteria for CLL)
Time Frame: 3 months
3 months
Non- hematological toxicity (graded according to NCI common toxicity criteria)
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Principal Investigator: Vinod Raina, MD, FRCP, Institute Rotary Cancer Hospital, AIIMS, New delhi, India

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ANTICIPATED)

March 1, 2009

Study Completion (ANTICIPATED)

March 1, 2009

Study Registration Dates

First Submitted

October 21, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (ESTIMATE)

December 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRCH-VAL-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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