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Sponsored by: |
All India Institute of Medical Sciences, New Delhi |
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Information provided by: | All India Institute of Medical Sciences, New Delhi |
ClinicalTrials.gov Identifier: | NCT00810680 |
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.
Condition | Intervention |
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Chronic Lymphocytic Leukemia |
Drug: Valproic acid |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Use of Valproic Acid in Relapsed or Refractory Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 10 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Valproic acid: Experimental |
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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vinod Raina, MD, FRCP | 91-11-2659 3679 ext 3659 | vinodraina@hotmail.com |
Contact: Prasanth Ganesan, MD | 91-99681-47800 | pg1980@gmail.com |
India, Delhi | |
Institute Rotary Cancer Hospital, All India Institute of Medical Sciences | Recruiting |
New Delhi, Delhi, India, 110029 | |
Contact: Vinod Raina, MD, FRCP 91- 11- 2659 3679 vinodraina@hotmail.com | |
Contact: Prasanth Ganesan, MD 91-99681-47800 pg1980@gmail.com | |
Principal Investigator: Vinod Raina, MD, FRCP | |
Sub-Investigator: Prasanth Ganesan, MD |
Principal Investigator: | Vinod Raina, MD, FRCP | Institute Rotary Cancer Hospital, AIIMS, New delhi, India |
Responsible Party: | Institute Rotary Cancer Hospital, AIIMS ( Dr. Vinod Raina ) |
Study ID Numbers: | IRCH-VAL-01 |
Study First Received: | October 21, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00810680 |
Health Authority: | India: Drugs Controller General of India |
chronic lymphocytic leukemia relapsed refractory valproic acid valproate |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell Valproic Acid |
Neurotransmitter Agents Neoplasms by Histologic Type Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Immune System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants |
Enzyme Inhibitors Antimanic Agents Pharmacologic Actions Neoplasms Therapeutic Uses GABA Agents Central Nervous System Agents Anticonvulsants |