Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia

Refractory Chronic Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01251250
• Other study ID #: I 169009
• Secondary ID: NCI-2010-02103
• Status: Withdrawn
• Phase: Phase 1
• First received: November 30, 2010
• Last updated: January 10, 2014
• Start date: December 2010

Study information

• Verified date: January 2014
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have a definitive diagnosis of CLL as defined by the IWCLL criteria

• Patients may not have received any prior treatment for management of CLL; (no more than 30 patients with treatment naive disease will be included in this study)

• Patients with advance stage disease (Rai Stage II-IV) may be included in this clinical trial if they refuse to take standard chemotherapeutic regimens

• Patients with relapsed or relapsed/ resistant may be included in this clinical trial if they refuse to take standard chemotherapeutic regimens

• Patients must understand and voluntarily sign an informed consent form

• Have an ECOG Performance Status of =< 2 at study entry

• Able to adhere to the study visit schedule and other protocol requirements

• Leukocytes >= 3,000/mcL

• Absolute neutrophil count >= 1,500/mcL

• Hemoglobin >= 10g/dl

• Platelets >= 50,000/mcl

• Total bilirubin within normal institutional limits

• AST (SGOT)/ ALT (SGPT) =< 2.5 X institutional ULN

• Patients of childbearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment

• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

• Trying to conceive, pregnant or breast feeding female patients

• Unwilling or unable to follow protocol requirements

• Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug

• Patients who are consuming other herbals or non-traditional therapies (i.e. green tea extracts and cumin) within the last 4 weeks(28 days) of initiating this clinical study; note: patient must have stopped herbal or other non-traditional therapies for CLL at least 28 days prior to initiating therapy on this study

• Patients with high-risk cytogenetic (del 17p, del 11q) determined by FISH analysis

• Prior organ transplant

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Refractory Chronic Lymphocytic Leukemia
• Stage II Chronic Lymphocytic Leukemia
• Stage III Chronic Lymphocytic Leukemia
• Stage IV Chronic Lymphocytic Leukemia

Intervention

Other:
• laboratory biomarker analysis
Correlative studies

Genetic:
• western blotting
Correlative studies
• gene expression analysis
Correlative studies

Other:
• pharmacological study
Correlative studies
• flow cytometry
Correlative studies

Genetic:
• fluorescence in situ hybridization
Correlative studies

Biological:
• azadirachta indica
Given orally

Genetic:
• reverse transcriptase-polymerase chain reaction
Correlative studies

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lowest clinically active and tolerable dose		After patients have completed at least 2 treatment courses	Yes