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Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia

Primary Purpose

Refractory Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
laboratory biomarker analysis
western blotting
gene expression analysis
pharmacological study
flow cytometry
fluorescence in situ hybridization
azadirachta indica
reverse transcriptase-polymerase chain reaction
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Chronic Lymphocytic Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Arm I

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Lowest clinically active and tolerable dose

    Secondary Outcome Measures

    Full Information

    First Posted
    November 30, 2010
    Last Updated
    January 10, 2014
    Sponsor
    Roswell Park Cancer Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01251250
    Brief Title
    Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia
    Official Title
    Phase I Clinical Trial of Neem Leaf Extract for the Treatment of Chronic Lymphocytic Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    lost sponsor support
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Roswell Park Cancer Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractory Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm I
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Intervention Description
    Correlative studies
    Intervention Type
    Genetic
    Intervention Name(s)
    western blotting
    Other Intervention Name(s)
    Blotting, Western, Western Blot
    Intervention Description
    Correlative studies
    Intervention Type
    Genetic
    Intervention Name(s)
    gene expression analysis
    Intervention Description
    Correlative studies
    Intervention Type
    Other
    Intervention Name(s)
    pharmacological study
    Other Intervention Name(s)
    pharmacological studies
    Intervention Description
    Correlative studies
    Intervention Type
    Other
    Intervention Name(s)
    flow cytometry
    Intervention Description
    Correlative studies
    Intervention Type
    Genetic
    Intervention Name(s)
    fluorescence in situ hybridization
    Other Intervention Name(s)
    fluorescence in situ hybridization (FISH)
    Intervention Description
    Correlative studies
    Intervention Type
    Biological
    Intervention Name(s)
    azadirachta indica
    Other Intervention Name(s)
    neem, neem tree
    Intervention Description
    Given orally
    Intervention Type
    Genetic
    Intervention Name(s)
    reverse transcriptase-polymerase chain reaction
    Other Intervention Name(s)
    RT-PCR
    Intervention Description
    Correlative studies
    Primary Outcome Measure Information:
    Title
    Lowest clinically active and tolerable dose
    Time Frame
    After patients have completed at least 2 treatment courses

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Asher Chanan-Khan
    Organizational Affiliation
    Roswell Park Cancer Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia

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