Status:
WITHDRAWN
Azadirachta Indica in Treating Patients With Chronic Lymphocytic Leukemia
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Refractory Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 p...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01251250
Start Date
December 1 2010
Last Update
January 13 2014
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