Phase
Condition
Non-hodgkin's Lymphoma
Lymphoproliferative Disorders
Leukemia
Treatment
rituximab
doxorubicin
vincristine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Histopathologic confirmation of one of the following cluster of differentiationantigen 20 positive (CD20+) B-cell non-Hodgkin's lymphomas (tissue diagnosticprocedures must be performed within 6 months of study entry and with biopsy materialavailable for review):
follicular lymphoma (NCI CTCAE grade 1 or 2)
immunoplasmacytoma/immunocytoma (Waldenstrom's macroglobulinemia)
splenic marginal zone B-cell lymphoma
extra-nodal marginal zone lymphoma of mucosa-associated lymphoid tumor (MALT)type
nodal marginal zone B-cell lymphoma
mantle cell lymphoma
Meets one of the following need-for-treatment criteria (with the exception of mantlecell lymphoma for which treatment is indicated):
presence of at least one of the following B-symptoms:
fever (>38ºC) of unclear etiology
night sweats
weight loss of greater than 10% within the prior 6 months
large tumor mass (bulky disease)
presence of lymphoma-related complications, including narrowing of ureters orbile ducts, tumor-related compression of a vital organ, lymphoma-induced pain,cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, orascites
hyperviscosity syndrome due to monoclonal gammopathy
CD20+ B cells in lymph node biopsy or other lymphoma pathology specimen.
No prior treatment (patients on "watch and wait" may enter the study if a recentbiopsy [obtained within the last 6 months] is available)
Adequate hematologic function (unless abnormalities related to lymphoma infiltrationof the bone marrow or hypersplenism due to lymphoma) as follows:
hemoglobin of >= 10.0 g/dL
absolute neutrophil count (ANC) >=1.5*10^9/L
platelet count >=100*10^9/L
Bidimensionally measurable disease (field not previously radiated)
Able to provide written informed consent
Eastern Cooperative Oncology Group (ECOG) Performance Status <=2
Estimated life expectancy >=6 months
Serum creatinine of <=2.0 mg/dL or creatinine clearance >=50 mL/min
Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5*upper limit ofnormal (ULN), and alkaline phosphatase and total bilirubin within normal limits
Left ventricular ejection fraction (LVEF) >= 50% by multiple gated acquisition scan (MUGA) or cardiac echocardiogram (ECHO), prior for any patient to be treated withR-CHOP
A medically accepted method of contraception to be used by women of childbearingpotential (not surgically sterile or at least 12 months naturally postmenopausal)
Men capable of producing offspring and not surgically sterile must practice abstinenceor use a barrier method of birth control.
Exclusion
Key Exclusion Criteria:
Chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL), or grade 3 follicularlymphoma
Transformed disease (bone marrow blasts are permitted; however, transformed diseaseindicating leukemic involvement is not permitted)
Central nervous system (CNS) lymphomatous involvement or leptomeningeal lymphoma
Prior radiation for NHL, except for a single course of locally delimited radiationtherapy with a radiation field not exceeding 2 adjacent lymph node regions
Active malignancy, other than NHL, within the past 3 years except for localizedprostate cancer treated with hormone therapy, cervical carcinoma in situ, breastcancer in situ, or non-melanoma skin cancer following definitive treatment
New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias orunstable angina, electrocardiograph (ECG) evidence of active ischemia or activeconduction system abnormalities, or myocardial infarction within the last 6 months (prior to study entry, ECG abnormalities at screening must be documented by theinvestigator as not medically relevant)
Known human immunodeficiency virus (HIV) positivity
Active hepatitis B or hepatitis C infection (hepatitis B surface antigen testingrequired)
Women who are pregnant or lactating
Corticosteroids for treatment of lymphoma within 28 days of study entry Chronicallyadministered low-dose corticosteroids (e.g., prednisone ≤20 mg/day) for indicationsother than lymphoma or lymphoma-related complications are permitted
Any serious uncontrolled, medical or psychological disorder that would impair theability of the patient to receive therapy
Any condition which places the patient at unacceptable risk or confounds the abilityof the investigators to interpret study data
Any other investigational agent within 28 days of study entry
Known hypersensitivity to bendamustine, mannitol, or other study-related drugs
Ann Arbor stage I disease.
Study Design
Connect with a study center
St. Vincent's Hospital
Darlinghurst, New South Wales 2010
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaSite Not Available
Cabrini Hospital Malvern
Malvern, Victoria 3144
AustraliaSite Not Available
Teva Investigational Site 315
Perth, Western Australia
AustraliaSite Not Available
Teva Investigational Site 305
Concord,
AustraliaSite Not Available
Teva Investigational Site 317
Douglas,
AustraliaSite Not Available
Teva Investigational Site 308
East Melbourne,
AustraliaSite Not Available
Teva Investigational Site 310
Fitzroy,
AustraliaSite Not Available
Teva Investigational Site 311
Fitzroy,
AustraliaSite Not Available
Teva Investigational Site 301
Garran,
AustraliaSite Not Available
Teva Investigational Site 316
Geelong,
AustraliaSite Not Available
Teva Investigational Site 304
Hobart,
AustraliaSite Not Available
Teva Investigational Site 312
Kurralta Park,
AustraliaSite Not Available
Teva Investigational Site 307
Melbourne,
AustraliaSite Not Available
Teva Investigational Site 306
North Terrace,
AustraliaSite Not Available
Teva Investigational Site 318
Parkville,
AustraliaSite Not Available
Teva Investigational Site 300
South Brisbane,
AustraliaSite Not Available
Westmead Hospital
Sydney, NSW 2145
AustraliaSite Not Available
Teva Investigational Site 303
Westmead,
AustraliaSite Not Available
Teva Investigational Site 314
Wodonga,
AustraliaSite Not Available
Teva Investigational Site 313
Woodville,
AustraliaSite Not Available
Teva Investigational Site 309
Woolloongabba,
AustraliaSite Not Available
Centro Goiano de Oncologia
Goiania, GO 74075-040
BrazilSite Not Available
Teva Investigational Site 503
Barretos,
BrazilSite Not Available
Fundacao Pio X11 - Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
BrazilSite Not Available
Teva Investigational Site 503
Barretos-SP,
BrazilSite Not Available
Teva Investigational Site 504
Brasilia,
BrazilSite Not Available
Teva Investigational Site 504
Brasilia, DF,
BrazilSite Not Available
Teva Investigational Site 506
Curitiba,
BrazilSite Not Available
Teva Investigational Site 505
Goiania-GO,
BrazilSite Not Available
Centro Goiano de Oncologia
Goiânia - GO, 74075-040
BrazilSite Not Available
Teva Investigational Site 505
Goiânia,
BrazilSite Not Available
Teva Investigational Site 502
Jau,
BrazilSite Not Available
Fundação Doutor Amaral Carvalho
Jaú, 17210-120
BrazilSite Not Available
Teva Investigational Site 509
Lajeado,
BrazilSite Not Available
Hospital Bruno Born
Lajeado - RS, 95900-000
BrazilSite Not Available
Teva Investigational Site 509
Lajeado-RS,
BrazilSite Not Available
Teva Investigational Site 507
Porto Alegre,
BrazilSite Not Available
Teva Investigational Site 508
Porto Alegre,
BrazilSite Not Available
Teva Investigational Site 511
Rio De Janeiro,
BrazilSite Not Available
Teva Investigational Site 511
Rio de Janeiro - RJ,
BrazilSite Not Available
Teva Investigational Site 500
Santo Andre,
BrazilSite Not Available
Centro de Estudos da Disciplina de Hematologia da Faculdade de Medicina do ABC
Santo André, 09060-650
BrazilSite Not Available
Teva Investigational Site 501
Sao Paulo,
BrazilSite Not Available
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador A1B3V6
CanadaSite Not Available
Royal Victoria Hospital
Montreal, Quebec H3A1A1
CanadaSite Not Available
Teva Investigational Site 202
Barrie,
CanadaSite Not Available
Teva Investigational Site 206
Calgary,
CanadaSite Not Available
Teva Investigational Site 200
Halifax,
CanadaSite Not Available
Teva Investigational Site 201
Ottawa,
CanadaSite Not Available
Teva Investigational Site 203
Vancouver,
CanadaSite Not Available
Teva Investigational Site 204
Winnipeg,
CanadaSite Not Available
Teva Investigational Site 602
Aguascalientes,
MexicoSite Not Available
Teva Investigational Site 603
Hermosillo,
MexicoSite Not Available
Teva Investigational Site 603
Hermosillo, Sonora,
MexicoSite Not Available
Teva Investigational Site 600
Monterrey,
MexicoSite Not Available
Teva Investigational Site 601
Monterrey,
MexicoSite Not Available
Teva Investigational Site 600
Monterrey - NL,
MexicoSite Not Available
Hospital General del Estado de Sonora
Sonora, 83000
MexicoSite Not Available
Teva Investigational Site 401
Auckland,
New ZealandSite Not Available
Teva Investigational Site 405
Auckland,
New ZealandSite Not Available
Teva Investigational Site 400
Christchurch,
New ZealandSite Not Available
Teva Investigational Site 402
Newtown,
New ZealandSite Not Available
Teva Investigational Site 404
Palmerston North,
New ZealandSite Not Available
Teva Investigational Site 403
Takapuna,
New ZealandSite Not Available
Wellington Hospital
Wellington, 6021
New ZealandSite Not Available
Teva Investigational Site 700
Lima,
PeruSite Not Available
Teva Investigational Site 701
Lima,
PeruSite Not Available
Teva Investigational Site 704
Lima,
PeruSite Not Available
Teva Investigational Site 702
Miraflores,
PeruSite Not Available
Teva Investigational Site 703
Miraflores,
PeruSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama
United StatesSite Not Available
Teva Investigational Site 165
Tucson, Arizona
United StatesSite Not Available
Teva Investigational Site 167
Little Rock, Arkansas
United StatesSite Not Available
Tower Cancer Research Foundation
Beverly Hills, California
United StatesSite Not Available
Teva Investigational Site 11
Corona, California
United StatesSite Not Available
Teva Investigational Site 21
Fountain Valley, California
United StatesSite Not Available
Teva Investigational Site 52
Fountain Valley, California
United StatesSite Not Available
Teva Investigational Site 64
Fullerton, California
United StatesSite Not Available
Scripps Cancer Center
LaJolla, California 92037
United StatesSite Not Available
Teva Investigational Site 40
Los Angeles, California
United StatesSite Not Available
Teva Investigational Site 53
Los Angeles, California
United StatesSite Not Available
Comprehensive Cancer Center
Palm Springs, California
United StatesSite Not Available
Compassionate Cancer Care Medical Group, Inc.
Riverside, California 92501
United StatesSite Not Available
Teva Investigational Site 57
San Diego, California
United StatesSite Not Available
Teva Investigational Site 15
Aurora, Colorado
United StatesSite Not Available
University of Colorado
Boulder, Colorado
United StatesSite Not Available
Rocky Mountain Cancer Center
Colorado Springs, Colorado 80909
United StatesSite Not Available
Teva Investigational Site 155
Denver, Colorado
United StatesSite Not Available
Teva Investigational Site 5
Fort Collins, Colorado
United StatesSite Not Available
Teva Investigational Site 70
New Britain, Connecticut
United StatesSite Not Available
Teva Investigational Site 37
Norwalk, Connecticut
United StatesSite Not Available
Teva Investigational Site 67
Southington, Connecticut
United StatesSite Not Available
Teva Investigational Site 58
Fort Myers, Florida
United StatesSite Not Available
Teva Investigational Site 38
Hollywood, Florida
United StatesSite Not Available
Teva Investigational Site 23
Jacksonville, Florida
United StatesSite Not Available
Teva Investigational Site 65
Lake Worth, Florida
United StatesSite Not Available
Teva Investigational Site 156
Miami, Florida
United StatesSite Not Available
Cancer Centers of Florida
Ocoee, Florida 34761
United StatesSite Not Available
Teva Investigational Site 160
Orlando, Florida
United StatesSite Not Available
Teva Investigational Site 68
Orlando, Florida
United StatesSite Not Available
Teva Investigational Site 72
Augusta, Georgia
United StatesSite Not Available
Teva Investigational Site 50
Columbus, Georgia
United StatesSite Not Available
Teva Investigational Site 73
Macon, Georgia
United StatesSite Not Available
Teva Investigational Site 49
Centralia, Illinois
United StatesSite Not Available
Teva Investigational Site 48
Chicago, Illinois
United StatesSite Not Available
Teva Investigational Site 9
Chicago, Illinois
United StatesSite Not Available
Teva Investigational Site 14
Normal, Illinois
United StatesSite Not Available
Teva Investigational Site 24
Beech Grove, Indiana
United StatesSite Not Available
Teva Investigational Site 152
Indianapolis, Indiana
United StatesSite Not Available
Teva Investigational Site 31
Iowa City, Iowa
United StatesSite Not Available
Teva Investigational Site 63
Waterloo, Iowa
United StatesSite Not Available
Kansas City Cancer Center
Overland Park, Kansas 66210
United StatesSite Not Available
Teva Investigational Site 47
Wichita, Kansas
United StatesSite Not Available
Teva Investigational Site 33
Lexington, Kentucky
United StatesSite Not Available
Teva Investigational Site 19
Shreveport, Louisiana
United StatesSite Not Available
Teva Investigational Site 43
Augusta, Maine
United StatesSite Not Available
Massachusetts General Hospital, Harvard University
Boston, Massachusetts
United StatesSite Not Available
Teva Investigational Site 74
Lowell, Massachusetts
United StatesSite Not Available
Teva Investigational Site 22
Duluth, Minnesota
United StatesSite Not Available
Teva Investigational Site 4
Saint Louis Park, Minnesota
United StatesSite Not Available
Park Nicollet Institute
St Louis Park, Minnesota 55416
United StatesSite Not Available
Teva Investigational Site 4
St. Louis Park, Minnesota
United StatesSite Not Available
Teva Investigational Site 162
Columbia, Missouri
United StatesSite Not Available
Teva Investigational Site 157
Kansas City, Missouri
United StatesSite Not Available
Teva Investigational Site 29
Morristown, New Jersey
United StatesSite Not Available
Teva Investigational Site 46
Albuquerque, New Mexico
United StatesSite Not Available
St. Vincent's Comprehensive Cancer Center
New York, New York
United StatesSite Not Available
Teva Investigational Site 8
Rochester, New York
United StatesSite Not Available
Teva Investigational Site 10
Syracuse, New York
United StatesSite Not Available
Teva Investigational Site 17
Charlotte, North Carolina
United StatesSite Not Available
Teva Investigational Site 151
Durham, North Carolina
United StatesSite Not Available
Teva Investigational Site 39
Fargo, North Dakota
United StatesSite Not Available
Teva Investigational Site 34
Cincinnati, Ohio
United StatesSite Not Available
Teva Investigational Site 60
Cincinnati, Ohio
United StatesSite Not Available
Teva Investigational Site 28
Cleveland, Ohio
United StatesSite Not Available
Providence Portland Medical Center
Portland, Oregon
United StatesSite Not Available
Teva Investigational Site 153
Springfield, Oregon
United StatesSite Not Available
Teva Investigational Site 59
Bethlehem, Pennsylvania
United StatesSite Not Available
Teva Investigational Site 44
Danville, Pennsylvania
United StatesSite Not Available
Teva Investigational Site 3
Philadelphia, Pennsylvania
United StatesSite Not Available
Teva Investigational Site 13
Pittsburgh, Pennsylvania
United StatesSite Not Available
Teva Investigational Site 7
Pottstown, Pennsylvania
United StatesSite Not Available
Teva Investigational Site 25
Charleston, South Carolina
United StatesSite Not Available
Teva Investigational Site 71
Columbia, South Carolina
United StatesSite Not Available
Teva Investigational Site 56
Chattanooga, Tennessee
United StatesSite Not Available
Teva Investigational Site 30
Nashville, Tennessee
United StatesSite Not Available
Teva Investigational Site 154
Arlington, Texas
United StatesSite Not Available
Teva Investigational Site 158
Arlington, Texas
United StatesSite Not Available
Teva Investigational Site 6
El Paso, Texas
United StatesSite Not Available
Teva Investigational Site 161
Fort Worth, Texas
United StatesSite Not Available
Teva Investigational Site 159
San Antonio, Texas
United StatesSite Not Available
Teva Investigational Site 166
Sugar Land, Texas
United StatesSite Not Available
Texas Oncology
Tyler, Texas 75702
United StatesSite Not Available
Teva Investigational Site 2
Salt Lake City, Utah
United StatesSite Not Available
Teva Investigational Site 18
Abingdon, Virginia
United StatesSite Not Available
Teva Investigational Site 35
Charlottesville, Virginia
United StatesSite Not Available
Teva Investigational Site 164
Norfolk, Virginia
United StatesSite Not Available
Cancer Outreach Asscociates, PC
Richlands, Virginia
United StatesSite Not Available
Teva Investigational Site 54
Richmond, Virginia
United StatesSite Not Available
Teva Investigational Site 42
Seattle, Washington
United StatesSite Not Available
Teva Investigational Site 150
Spokane, Washington
United StatesSite Not Available
Teva Investigational Site 163
Vancouver, Washington
United StatesSite Not Available
Teva Investigational Site 66
Morgantown, West Virginia
United StatesSite Not Available
Teva Investigational Site 41
Madison, Wisconsin
United StatesSite Not Available
Dean Foundation
Middleton, Wisconsin
United StatesSite Not Available
Teva Investigational Site 62
Wausau, Wisconsin
United StatesSite Not Available
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