Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia
Status: | Archived |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 7/1/2011 |
Start Date: | December 2010 |
Phase I Clinical Trial of Neem Leaf Extract for the Treatment of Chronic Lymphocytic Leukemia
RATIONALE: Azadirachta indica may be an effective treatment for chronic lymphocytic
leukemia. PURPOSE: This phase I trial is studying the side effects and best dose of
Azadirachta indica in treating patients with 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.
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