|Phase III||Supportive care||Completed||18 and over||NCI, Other||CCCWFU98308|
U10CA081851, WFU-07-02-03, NCT00752895
RATIONALE: 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.
PURPOSE: 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.
Further Study Information
- 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.
- 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).
- 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.
- Diagnosis of chronic lymphocytic leukemia (CLL)
- Phenotypic evidence (i.e., flow cytometry or bone marrow biopsy) of disease
- Untreated CLL allowed
- 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
Trial Lead Organizations/Sponsors
Wake Forest University CCOP Research BaseNational Cancer Institute
|Kevin High||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00752895
ClinicalTrials.gov processed this data on January 15, 2014
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