A Phase III Randomized, Double-Blind, Placebo Controlled Trial of North American Ginseng Extract (CVT-E002; COLD-fX®) to Prevent Respiratory Infection and Reduce Antibiotic Use in Patients With Chronic Lymphocytic Leukemia

Trial Information

A Phase III Randomized, Double-Blind, Placebo Controlled Trial of North American Ginseng Extract (CVT-E002; COLD-fX®) to Prevent Respiratory Infection and Reduce Antibiotic Use in Patients With Chronic Lymphocytic Leukemia

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.