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An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma

Thank you

Trial Information

An Open-Label, Randomized, Parallel-Group Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With Rituximab, Cyclophosphamide, Vincristine, and Prednisone (R-CVP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL)


Key

Inclusion Criteria:



- Histopathologic confirmation of one of the following CD20+ B-cell non-Hodgkin's
lymphomas. Tissue diagnostic procedures must be performed within 6 months of study
entry and with biopsy material available for review:

- follicular lymphoma (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 mantle
cell lymphoma for which treatment is indicated):

- presence of at least one of the following B-symptoms:

1. fever (>38ºC) of unclear etiology

2. night sweats

3. 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 or
bile ducts, tumor-related compression of a vital organ, lymphoma induced pain,
cytopenias related to lymphoma/leukemia, splenomegaly, pleural effusions, or
ascites

- hyperviscosity syndrome due to monoclonal gammopathy

- CD20 positive 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 recent
biopsy (obtained within the last 6 months) is available.

- Adequate hematologic function (unless abnormalities related to lymphoma infiltration
of the bone marrow or hypersplenism due to lymphoma) as follows:

- hemoglobin of >= 10.0 g/dl

- absolute neutrophil count (ANC) >= 1.5 x 10 9th power/L

- platelet count >= 100 x 10 9th power/L

- Bidimensionally measurable disease (field not previously radiated).

- Able to provide written informed consent.

- ECOG performance status <= 2.

- Estimated life expectancy >= 6 months.

- Serum creatinine of <= 2.0 mg/dL or creatinine clearance >= 50 mL/min.

- ALT and AST ≤ 2.5 x 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 with
R-CHOP.

- A medically accepted method of contraception to be used by women of childbearing
potential (not surgically sterile or at least 12 months naturally postmenopausal).

- Men capable of producing offspring and not surgically sterile must practice
abstinence or use a barrier method of birth control.

Key Exclusion Criteria:

- Chronic lymphocytic leukemia, small lymphocytic lymphoma (SLL), or grade 3 follicular
lymphoma.

- Transformed disease. Bone marrow blasts are permitted, however, transformed disease
indicating 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 radiation
therapy with a radiation field not exceeding 2 adjacent lymph node regions.

- Active malignancy, other than NHL, within the past 3 years except for localized
prostate cancer treated with hormone therapy, cervical carcinoma in situ, breast
cancer in situ, or non-melanoma skin cancer following definitive treatment.

- New York Heart Association (NYHA) Class III or IV heart failure, arrhythmias or
unstable angina, electrocardiographic evidence of active ischemia or active
conduction system abnormalities, or myocardial infarction within the last 6 months.
(Prior to study entry, ECG abnormalities at screening must be documented by the
investigator as not medically relevant).

- Known human immunodeficiency virus (HIV) positivity.

- Active hepatitis B or hepatitis C infection (Hepatitis B surface antigen testing
required).

- Women who are pregnant or lactating.

- Corticosteroids for treatment of lymphoma within 28 days of study entry. Chronically
administered low-dose corticosteroids (e.g., prednisone ≤20 mg/day) for indications
other than lymphoma or lymphoma-related complications are permitted.

- Any serious uncontrolled, medical or psychological disorder that would impair the
ability of the patient to receive therapy.

- Any condition which places the patient at unacceptable risk or confounds the ability
of 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.

- The patient has Ann Arbor stage I disease.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Compare the complete response (CR) rate at end of treatment of bendamustine and rituximab (BR) with either R-CVP or R-CHOP in the treatment of patients with advanced indolent non-Hodgkin's lymphoma or mantle cell lymphoma.

Outcome Time Frame:

6-8 cycles, or 18-32 weeks

Safety Issue:

No

Principal Investigator

Sponsor's Medical Expert

Investigator Role:

Study Director

Investigator Affiliation:

Cephalon

Authority:

United States: Food and Drug Administration

Study ID:

C18083/3064/NL/MN

NCT ID:

NCT00877006

Start Date:

April 2009

Completion Date:

March 2017

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Mantle Cell Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location

Teva Investigational Site 165Tucson, Arizona  
Teva Investigational Site 167Little Rock, Arkansas  
Teva Investigational Site 52Fountain Valley, California  
Teva Investigational Site 21Fountain Valley, California  
Teva Investigational Site 64Fullerton, California  
Teva Investigational Site 40Los Angeles, California  
Teva Investigational Site 53Los Angeles, California  
Teva Investigational Site 57San Diego, California  
Teva Investigational Site 15Aurora, Colorado  
Teva Investigational Site 155Denver, Colorado  
Teva Investigational Site 5Fort Collins, Colorado  
Teva Investigational Site 70New Britain, Connecticut  
Teva Investigational Site 37Norwalk, Connecticut  
Teva Investigational Site 67Southington, Connecticut  
Teva Investigational Site 58Fort Myers, Florida  
Teva Investigational Site 38Hollywood, Florida  
Teva Investigational Site 65Lake Worth, Florida  
Teva Investigational Site 68Orlando, Florida  
Teva Investigational Site 160Orlando, Florida  
Teva Investigational Site 72Augusta, Georgia  
Teva Investigational Site 50Columbus, Georgia  
Teva Investigational Site 73Macon, Georgia  
Teva Investigational Site 9Chicago, Illinois  
Teva Investigational Site 48Chicago, Illinois  
Teva Investigational Site 24Beech Grove, Indiana  
Teva Investigational Site 152Indianapolis, Indiana  
Teva Investigational Site 31Iowa City, Iowa  
Teva Investigational Site 47Wichita, Kansas  
Teva Investigational Site 33Lexington, Kentucky  
Teva Investigational Site 19Shreveport, Louisiana  
Teva Investigational Site 43Augusta, Maine  
Teva Investigational Site 74Lowell, Massachusetts  
Teva Investigational Site 22Duluth, Minnesota  
Teva Investigational Site 4St. Louis Park, Minnesota  
Teva Investigational Site 162Columbia, Missouri  
Teva Investigational Site 157Kansas City, Missouri  
Teva Investigational Site 46Albuquerque, New Mexico  
Teva Investigational Site 10Syracuse, New York  
Teva Investigational Site 17Charlotte, North Carolina  
Teva Investigational Site 39Fargo, North Dakota  
Teva Investigational Site 28Cleveland, Ohio  
Teva Investigational Site 153Springfield, Oregon  
Teva Investigational Site 59Bethlehem, Pennsylvania  
Teva Investigational Site 44Danville, Pennsylvania  
Teva Investigational Site 13Pittsburgh, Pennsylvania  
Teva Investigational Site 7Pottstown, Pennsylvania  
Teva Investigational Site 25Charleston, South Carolina  
Teva Investigational Site 71Columbia, South Carolina  
Teva Investigational Site 56Chattanooga, Tennessee  
Teva Investigational Site 30Nashville, Tennessee  
Teva Investigational Site 158Arlington, Texas  
Teva Investigational Site 154Arlington, Texas  
Teva Investigational Site 161Fort Worth, Texas  
Teva Investigational Site 159San Antonio, Texas  
Teva Investigational Site 166Sugar Land, Texas  
Teva Investigational Site 2Salt Lake City, Utah  
Teva Investigational Site 18Abingdon, Virginia  
Teva Investigational Site 35Charlottesville, Virginia  
Teva Investigational Site 164Norfolk, Virginia  
Teva Investigational Site 54Richmond, Virginia  
Teva Investigational Site 42Seattle, Washington  
Teva Investigational Site 150Spokane, Washington  
Teva Investigational Site 163Vancouver, Washington  
Teva Investigational Site 66Morgantown, West Virginia  
Teva Investigational Site 41Madison, Wisconsin  
Teva Investigational Site 62Wausau, Wisconsin