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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 CenterMaywood, Illinois  60153-5500
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Evanston Northwestern Healthcare - Evanston HospitalEvanston, Illinois  60201-1781
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
MeritCare BemidjiBemidji, Minnesota  56601
MeritCare BroadwayFargo, North Dakota  58122
CCOP - MeritCare HospitalFargo, North Dakota  58122
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
CCOP - OchsnerNew Orleans, Louisiana  70121
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Southwest Medical CenterLiberal, Kansas  67901
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Genesis Medical Center - West CampusDavenport, Iowa  52804
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Pennington Cancer Center at Baton Rouge GeneralBaton Rouge, Louisiana  70806
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Community Cancer Center of MonroeMonroe, Michigan  48162
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Hematology Oncology CenterElyria, Ohio  44035
Flower Hospital Cancer CenterSylvania, Ohio  43560
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
St. Joseph Hospital Regional Cancer Center - OrangeOrange, California  92868-3849
Presbyterian Hospital of DallasDallas, Texas  75231
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Galesburg Clinic, PCGalesburg, Illinois  61401
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Midwest Hematology Oncology Group, IncorporatedSaint Louis, Missouri  63109
Trinity Cancer Center at Trinity Medical Center - 7th Street CampusMoline, Illinois  61265
Center for Cancer Care at Exeter HospitalExeter, New Hampshire  03833
St. Vincent Oncology CenterIndianapolis, Indiana  46260