Status:
UNKNOWN
Study of Efficacy and Safety of Valproic Acid in Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 sta...
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 antibodie...
Eligibility Criteria
Inclusion
- 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
- Any therapy for CLL within 4 weeks before initiating treatment on this study.
- Pregnancy.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00810680
Start Date
September 1 2008
End Date
March 1 2009
Last Update
December 18 2008
Active Locations (1)
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1
Institute Rotary Cancer Hospital, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029