Chronic Lymphocytic Leukemia Clinical Trial
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
Summary
RATIONALE: American ginseng extract may prevent or reduce acute respiratory illness in patients with leukemia-cll/" >chronic lymphocytic leukemia. It is not yet known whether American ginseng extract is more effective than a placebo in preventing respiratory infections.
PURPOSE: This randomized 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.
Full Description
OBJECTIVES:
Primary
To assess the effect of American ginseng extract on the number of days of acute respiratory infection (ARI) during the peak respiratory illness season (January-March) in patients with chronic lymphocytic leukemia (CLL).
To determine the safety of American ginseng extract in these patients evaluated according to NCI CTCAE v3.0.
Secondary
To assess the effect of this treatment on antibiotic use days (AUDs).
To assess the effect of this treatment on the rate of all infections diagnosed by a physician.
To assess the effect of this treatment on the duration and severity of each ARI episode.
To assess the effect of this treatment on major infections defined as infection severe enough to require hospitalization or intravenous antibiotics.
To assess the effect of this treatment on the incidence of herpes zoster infection defined as an episode of physician-diagnosed zoster infection.
To assess the effect of this treatment on CLL disease activity (i.e., serum IgG, total lymphocyte count, platelet count, and Rai staging).
To determine the incidence of ARI and type of illness in an untreated cohort of CLL patients over an entire winter respiratory illness season (January 1- April 30).
Tertiary
To determine the effect of this treatment on the incidence of influenza and respiratory syncytial virus confirmed by a physician.
OUTLINE: This is a multicenter study. Patients are stratified according to antibiotic prophylaxis with trimethoprim-sulfamethoxazole (yes vs no), serum IgG (≤ 500 mg/dL vs > 500 mg/dL), and influenza vaccine status (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral American ginseng extract twice daily.
Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for up to 4 months in the absence of illness or adverse events.
After completion of study treatment, patients are followed at 4 weeks by phone.
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
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