Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2025-12-24 @ 2:08 PM
NCT ID:
NCT00752895
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of chronic lymphocytic leukemia (CLL)
* Phenotypic evidence (i.e., flow cytometry or bone marrow biopsy) of disease
* Untreated CLL allowed
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* Life expectancy \> 12 months
* Creatinine \< 2.0 mg/dL OR creatinine clearance \> 50 mL/min
* AST/ALT ≤ 2.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception prior to and during study treatment
* No known cirrhosis, collagen vascular disease, multiple sclerosis, or HIV positivity
* No other prior or concurrent malignancies except for non-melanoma skin cancers or carcinoma in situ of the cervix
* Other prior malignancies allowed provided the patient has been disease-free for \> 5 years
* No uncontrolled intercurrent illness including, but not limited to, any of the following:
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* No psychiatric or social illness that would limit compliance with study requirements
* No history of allergy or other adverse response to ginseng products
* No history of seasonal or environmental allergies that require ongoing treatment with antihistamines, intranasal corticosteroids, or systemic corticosteroids
PRIOR CONCURRENT THERAPY:
* More than 3 months since prior and no concurrent chlorambucil
* At least 1 month since prior and no other concurrent herbal ginseng products
* No prior or concurrent fludarabine, alemtuzumab, rituximab, intravenous immunoglobulin, or hematopoietic stem cell transplantation
* No concurrent corticosteroids (20 mg/day of prednisone or equivalent)
* No concurrent antibiotic prophylaxis, except for trimethoprim-sulfamethoxazole
* No concurrent warfarin
* No other concurrent investigational or commercial agents or other therapies with the intent to treat the patient's malignancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00752895
Study Brief:
Protocol Section:
NCT00752895