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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
N/A
Not Enrolling
Both
Leukemia

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


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.

Inclusion 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

Type of Study:

Interventional

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:

No

Principal Investigator

Kevin High, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CCCWFU98308

NCT ID:

NCT00752895

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

Name

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - North Shore University Hospital Manhasset, New York  11030
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Rush-Copley Cancer Care Center Aurora, Illinois  60507
Evanston Northwestern Healthcare - Evanston Hospital Evanston, Illinois  60201-1781
Carle Cancer Center at Carle Foundation Hospital Urbana, Illinois  61801
Saint Anthony Memorial Health Centers Michigan City, Indiana  46360
MeritCare Bemidji Bemidji, Minnesota  56601
MeritCare Broadway Fargo, North Dakota  58122
CCOP - MeritCare Hospital Fargo, North Dakota  58122
Sanford Cancer Center at Sanford USD Medical Center Sioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PC Sioux Falls, South Dakota  57105
Avera Cancer Institute Sioux Falls, South Dakota  57105
CCOP - Ochsner New Orleans, Louisiana  70121
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
Methodist Medical Center of Illinois Peoria, Illinois  61636
CCOP - Montana Cancer Consortium Billings, Montana  59101
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Long Island Jewish Medical Center New Hyde Park, New York  11040
St. Vincent Indianapolis Hospital Indianapolis, Indiana  46260
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic Foundation New Orleans, Louisiana  70121
Medical University of Ohio Cancer Center Toledo, Ohio  43614
Toledo Hospital Toledo, Ohio  43606
St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - Escanaba Escanaba, Michigan  49431
Dickinson County Healthcare System Iron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green Bay Green Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Green Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital Green Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical Center Marinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto Falls Oconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay, Wisconsin  54235
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
Southwest Medical Center Liberal, Kansas  67901
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital Gape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Don Monti Comprehensive Cancer Center at North Shore University Hospital Manhasset, New York  11030
Helen and Harry Gray Cancer Center at Hartford Hospital Hartford, Connecticut  06102-5037
St. Joseph Medical Center Bloomington, Illinois  61701
Graham Hospital Canton, Illinois  61520
Memorial Hospital Carthage, Illinois  62321
Eureka Community Hospital Eureka, Illinois  61530
Galesburg Cottage Hospital Galesburg, Illinois  61401
Mason District Hospital Havana, Illinois  62644
Hopedale Medical Complex Hopedale, Illinois  61747
McDonough District Hospital Macomb, Illinois  61455
BroMenn Regional Medical Center Normal, Illinois  61761
Community Cancer Center Normal, Illinois  61761
Community Hospital of Ottawa Ottawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa, Illinois  61350
Cancer Treatment Center at Pekin Hospital Pekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria, Illinois  61615
OSF St. Francis Medical Center Peoria, Illinois  61637
Proctor Hospital Peoria, Illinois  61614
Illinois Valley Community Hospital Peru, Illinois  61354
Perry Memorial Hospital Princeton, Illinois  61356
St. Margaret's Hospital Spring Valley, Illinois  61362
Genesis Medical Center - West Campus Davenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
Pennington Cancer Center at Baton Rouge General Baton Rouge, Louisiana  70806
Mary Bird Perkins Cancer Center - Baton Rouge Baton Rouge, Louisiana  70809
Medical Center of Louisiana - New Orleans New Orleans, Louisiana  70112
Hickman Cancer Center at Bixby Medical Center Adrian, Michigan  49221
Community Cancer Center of Monroe Monroe, Michigan  48162
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Creighton University Medical Center Omaha, Nebraska  68131-2197
Lima Memorial Hospital Lima, Ohio  45804
St. Luke's Hospital Maumee, Ohio  43537
Northwest Ohio Oncology Center Maumee, Ohio  43537
St. Charles Mercy Hospital Oregon, Ohio  43616
North Coast Cancer Care, Incorporated Sandusky, Ohio  44870
Mercy Hospital of Tiffin Tiffin, Ohio  44883
Toledo Clinic, Incorporated - Main Clinic Toledo, Ohio  43623
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Cancer Resource Center - Lincoln Lincoln, Nebraska  68510
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville, Michigan  48144
Mercy Memorial Hospital - Monroe Monroe, Michigan  48162
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Hematology Oncology Center Elyria, Ohio  44035
Flower Hospital Cancer Center Sylvania, Ohio  43560
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
St. Joseph Hospital Regional Cancer Center - Orange Orange, California  92868-3849
Presbyterian Hospital of Dallas Dallas, Texas  75231
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Galesburg Clinic, PC Galesburg, Illinois  61401
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
Center for Cancer Care at Exeter Hospital Exeter, New Hampshire  03833
St. Vincent Oncology Center Indianapolis, Indiana  46260