NCT01251250

Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia

Phase I Clinical Trial of Neem Leaf Extract for the Treatment of Chronic Lymphocytic Leukemia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Refractory Chronic Lymphocytic Leukemia
• Stage II Chronic Lymphocytic Leukemia
• Stage III Chronic Lymphocytic Leukemia
• Stage IV Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Correlative studies
GENETIC	western blotting	Correlative studies
GENETIC	gene expression analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
OTHER	flow cytometry	Correlative studies
GENETIC	fluorescence in situ hybridization	Correlative studies
BIOLOGICAL	azadirachta indica	Given orally
GENETIC	reverse transcriptase-polymerase chain reaction	Correlative studies

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-07-01
• First posted: 2010-12-01
• Last updated: 2014-01-13