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

Information source: All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Lymphocytic Leukemia

Intervention: Valproic acid (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: All India Institute of Medical Sciences, New Delhi

Official(s) and/or principal investigator(s):
Vinod Raina, MD, FRCP, Principal Investigator, Affiliation: Institute Rotary Cancer Hospital, AIIMS, New delhi, India

Overall contact:
Vinod Raina, MD, FRCP, Phone: 91-11-2659 3679, Ext: 3659, Email: vinodraina@hotmail.com


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.

Clinical Details

Official title: Use of Valproic Acid in Relapsed or Refractory Chronic Lymphocytic Leukemia

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Best clinical response as defined by NCIWG criteria for CLL

Secondary outcome:

Hematological toxicity (graded according to NCIWG criteria for CLL)

Non- hematological toxicity (graded according to NCI common toxicity criteria)

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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) - 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.

Locations and Contacts

Vinod Raina, MD, FRCP, Phone: 91-11-2659 3679, Ext: 3659, Email: vinodraina@hotmail.com

Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi, Delhi 110029, India; Recruiting
Vinod Raina, MD, FRCP, Phone: 91- 11- 2659 3679, Email: vinodraina@hotmail.com
Prasanth Ganesan, MD, Phone: 91-99681-47800, Email: pg1980@gmail.com
Vinod Raina, MD, FRCP, Principal Investigator
Prasanth Ganesan, MD, Sub-Investigator
Additional Information

Related publications:

Bokelmann 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.

Starting date: September 2008
Last updated: December 17, 2008

Page last updated: August 20, 2015

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