In This SectionTexas Health Research & Education Institute
Clinical Trials
Disease or Condition
Leukemia
Title
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With Chronic Lymphocytic Leukemia (Cancer)
Description
American ginseng extract may prevent or reduce acute respiratory illness in patients with chronic lymphocytic leukemia. It is not yet known whether American ginseng extract is more effective than a placebo in preventing respiratory infections. This randomized phase III trial is studying the side effects of American ginseng extract and to see how well it works compared with a placebo in preventing respiratory infection and in reducing antibiotic use in patients with chronic lymphocytic leukemia.
IRB Number
Pro618
Inclusion/Notes
INCLUSION:
Patients age at least 18 years old.
Subjects must have phenotypic evidence (ie. flow cytometry or bone marrow biopsy) of chronic lymphocytic leukemia.
Life expectancy of greater than 12 months.
Patients must have normal organ function as evidenced by AST, ALT , TBILI, Creatinine or Creatinine Clearance values.
Patients may not be receiving any other investigational agents.
Untreated Chronic Lymphocytic Leukemia.
EXCLUSION:
Patients with a history of HIV-1, cirrhosis, collagen vascular disease or multiple sclerosis, malignancy other than CLL (nonmelanoma skin cancer & carcinoma in situ of the cervix are allowed).
Patients with previous malignancies and have been disease free for more than 5 years are allowed.
History of seasonal or environmental allergies that requires ongoing treatment with antihistamines, or intranasal or systemic corticosteroids.
Patients who use of other herbal ginseng products(and unwilling to discontinue their use for at least one month prior to initiating therapy with either CVT-E002 or placebo).
Patients with a history of allergy or other adverse response to ginseng products.
Patients using antibiotic prophylaxis other than trimethoprim-sulfamethoxazole.
Patients who are currently using warfarin.
Patients with uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women.
Women who are breastfeeding (unless they agree to discontinue breastfeeding during the study.
