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

• Status: Unknown status
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: All India Institute of Medical Sciences, New Delhi
• Treatments: Valproic Acid

Criteria

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.