Phase I Clinical Trial of Neem Leaf Extract for the Treatment of Chronic Lymphocytic Leukemia
PRIMARY OBJECTIVES: I. To determine the lowest dose of neem leaf extract (NLE) with
antileukemic effect and acceptable toxicity in patients with chronic lymphocytic leukemia
(CLL). II. Establish the safety and toxicity of NLE in patients with CLL. SECONDARY
OBJECTIVES: I. Determine the efficacy of NLE in patients with CLL defined as overall
clinical response (CR + PR) by the IWCLL criterion. II. To develop a
pharmacokinetic/pharmacodynamic model relating neem leaf extract exposure to toxicity and
pharmacodynamic endpoints in CLL patients that will allow personalized dosing to target
optimal drug exposure. III. To conduct correlative studies. OUTLINE: This is a
dose-escalation study. Patients receive oral Azadirachta indica once daily on days 1-28.
Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or
unacceptable toxicity. After completion of study treatment, patients are followed up every 3
months for 1 year.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Lowest clinically active and tolerable dose
After patients have completed at least 2 treatment courses
Yes
Asher Chanan-Khan
Principal Investigator
Roswell Park Cancer Institute
United States: Institutional Review Board
I 169009
NCT01251250
December 2010
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