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

NCT ID: NCT00810680

Last Updated: 2008-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Lymphocytic Leukemia

Keywords

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chronic lymphocytic leukemia relapsed refractory valproic acid valproate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Valproic acid

Group Type EXPERIMENTAL

Valproic acid

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Valproate Sodium Valproate Depakote

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Institute Rotary Cancer Hospital, AIIMS

Principal Investigators

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Vinod Raina, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Institute Rotary Cancer Hospital, AIIMS, New delhi, India

Locations

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Institute Rotary Cancer Hospital, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Vinod Raina, MD, FRCP

Role: CONTACT

Phone: 91-11-2659 3679

Email: [email protected]

Prasanth Ganesan, MD

Role: CONTACT

Phone: 91-99681-47800

Email: [email protected]

Facility Contacts

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Vinod Raina, MD, FRCP

Role: primary

Prasanth Ganesan, MD

Role: backup

References

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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. doi: 10.2119/2007-00084.Bokelmann.

Reference Type BACKGROUND
PMID: 17973028 (View on PubMed)

Other Identifiers

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IRCH-VAL-01

Identifier Type: -

Identifier Source: org_study_id