Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With Chronic Lymphocytic Leukemia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI	CCCWFU-98308 CCCWFU # 98308, NCT00752895

Special Category: NCI Web site featured trial

Objectives

Primary

1. 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).
2. To determine the safety of American ginseng extract in these patients evaluated according to NCI CTCAE v3.0.

Secondary

1. To assess the effect of this treatment on antibiotic use days (AUDs).
2. To assess the effect of this treatment on the rate of all infections diagnosed by a physician.
3. To assess the effect of this treatment on the duration and severity of each ARI episode.
4. To assess the effect of this treatment on major infections defined as infection severe enough to require hospitalization or intravenous antibiotics.
5. To assess the effect of this treatment on the incidence of herpes zoster infection defined as an episode of physician-diagnosed zoster infection.
6. To assess the effect of this treatment on CLL disease activity (i.e., serum IgG, total lymphocyte count, platelet count, and Rai staging).
7. 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

1. To determine the effect of this treatment on the incidence of influenza and respiratory syncytial virus confirmed by a physician.

Entry Criteria

Disease Characteristics:

• Diagnosis of chronic lymphocytic leukemia (CLL)
  • Phenotypic evidence (i.e., flow cytometry or bone marrow biopsy) of disease



• Untreated CLL allowed

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

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

Expected Enrollment

Outcomes

Number of acute respiratory infection (ARI) days during a fixed 3-month period
Safety according to NCI CTCAE v3.0

Number of antibiotic use days
Rate of all infections
Duration and severity of each ARI episode
Incidence of major infections
Incidence of herpes zoster
Chronic lymphocytic leukemia disease activity
Incidence and type of ARI in untreated cohort
Incidence of confirmed influenza and respiratory syncytial virus 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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University CCOP Research Base

Kevin High, MD, Protocol chair		Ph: 336-716-4584; 800-446-2255
Bayard Powell, MD, Protocol co-chair		Ph: 336-713-5407 Email: bpowell@wfubmc.edu
David Hurd, MD, Protocol co-chair		Ph: 336-716-4464 Email: dhurd@wfubmc.edu
Denise Levitan, MD, Protocol co-chair		Ph: 336-713-5440
Leslie Ellis, MD, Protocol co-chair		Ph: 336-716-5847; 800-446-2255

Related Information

Featured trial article

Registry Information
Official Title		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 Start Date		2008-09-11
Trial Completion Date		2009-04-30 (estimated)
Registered in ClinicalTrials.gov		NCT00752895
Date Submitted to PDQ		2008-09-09
Information Last Verified		2009-01-01
NCI Grant/Contract Number		CA12197