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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

Phase 3
18 Years
Not Enrolling

Thank you

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



- 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

- To assess the effect of this treatment on the duration and severity of each ARI

- 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.

Inclusion Criteria


- 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

- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Number of acute respiratory infection (ARI) days during a fixed 3-month period

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Kevin High, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Federal Government

Study ID:




Start Date:

September 2008

Completion Date:

June 2009

Related Keywords:

  • Leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Respiratory Tract Infections



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