An interventional study of Valproic acid in Chronic Lymphocytic Leukemia, sponsored by All India Institute of Medical Sciences, New Delhi. Status unknown at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-12-18.
Sponsored by All India Institute of Medical Sciences, New Delhi · Not applicable, Interventional, and Treatment
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.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 10 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →All India Institute of Medical Sciences, New Delhi is the lead sponsor of 146 studies on the registry; 16 are open to participants now.
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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.
Also known as: Valproate, Sodium Valproate, Depakote
Best clinical response as defined by NCIWG criteria for CLL
Time frame: 3 months
Hematological toxicity (graded according to NCIWG criteria for CLL)
Time frame: 3 months
Non- hematological toxicity (graded according to NCI common toxicity criteria)
Time frame: 3 months
This study is status unknown, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences, New Delhi