Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 1 of 1 for:    E2408
Previous Study | Return to List | Next Study

Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Eastern Cooperative Oncology Group.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01216683
First received: October 6, 2010
Last updated: March 13, 2015
Last verified: June 2014
  Purpose

RATIONALE: Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether giving bendamustine hydrochloride and rituximab together alone is more effective than giving bendamustine hydrochloride and rituximab together with bortezomib or lenalidomide in treating follicular lymphoma.

PURPOSE: This randomized phase II trial is studying giving bendamustine hydrochloride and rituximab together with or without bortezomib followed by rituximab with or without lenalidomide to see how well they work in treating patients with high-risk stage II, stage III, or stage IV follicular lymphoma.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: bendamustine hydrochloride
Drug: bortezomib
Drug: lenalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 3-Arm Randomized Phase II Trial of Bendamustine-Rituximab (BR) Followed by Rituximab vs Bortezomib-BR (BVR) Followed by Rituximab vs BR Followed by Lenalidomide/Rituximab in High Risk Follicular Lymphoma

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Complete remission (CR) rate after induction therapy [ Designated as safety issue: No ]
  • 1-year post-induction disease-free survival rate [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival at 3 years [ Designated as safety issue: No ]
  • Overall survival at 5 years [ Designated as safety issue: No ]
  • Effect of continuation therapy in converting partial response or stable disease from induction into CR [ Designated as safety issue: No ]
  • Association of the original FLIPI-1 score with the recently reported FLIPI-2 score [ Designated as safety issue: No ]
  • Relationship between FLIPI-2 score and outcome [ Designated as safety issue: No ]
  • Overall health-related quality of life and disease-related symptoms as assessed by the FACT-Lymphoma subscale (FACTLym) [ Designated as safety issue: No ]
  • Treatment-related symptoms as assessed by the 13-item FACT-Fatigue scale and the 11-item FACT/GOG-Neurotoxicity scale [ Designated as safety issue: No ]
  • Disease-related symptoms and distress as assessed by the patient self-report assessment [ Designated as safety issue: No ]
  • Number of co-morbidities as assessed by the Cumulative Illness Rating Scale (CIRS) at 2 years [ Designated as safety issue: No ]
  • Relationship between CIRS score and outcome [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: December 2010
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Given IV
Drug: bendamustine hydrochloride
Given IV
Experimental: Arm II
Patients receive rituximab IV on day 1, bortezomib IV on days 1, 4, 8, and 11, and bendamustine hydrochloride IV over 1 hour on days 1 and 4. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, patients receive rituximab as in arm I.
Biological: rituximab
Given IV
Drug: bendamustine hydrochloride
Given IV
Drug: bortezomib
Given IV
Experimental: Arm III
Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 1 hour on days 1 and 2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Immediately after completing induction therapy, patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for 13 courses in the absence of disease progression or unacceptable toxicity. Beginning 4 weeks after the completion of induction therapy, patients receive rituximab IV on day 1. Treatment repeats every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Given IV
Drug: bendamustine hydrochloride
Given IV
Drug: lenalidomide
Given orally

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed (biopsy-proven) diagnosis of follicular B-cell non-Hodgkin lymphoma with no evidence of transformation to large cell histology

    • Patients having both diffuse and follicular architectural elements are eligible if the histology is predominantly follicular (i.e., ≥ 50% of the cross-sectional area) and there is no evidence of transformation to a large cell histology
    • Diagnostic confirmation (i.e., core needle or excisional lymph node biopsy) required if the interval since tissue diagnosis of low-grade malignant lymphoma is > 24 months

      • Bone marrow biopsy alone not acceptable
  • Stage II, III, or IV AND grade 1, 2, or 3a disease
  • Must meet criteria for High Tumor Burden (higher risk) as defined by either the Groupe D'Etude des Lymphomes Follicularies (GELF) criteria OR the follicular lymphoma international prognostic index (FLIPI) as defined below:

    • Patient must meet ≥ 1 of the following GELF criteria:

      • Nodal or extranodal mass ≥ 7 cm
      • At least 3 nodal masses > 3.0 cm in diameter
      • Systemic symptoms due to lymphoma or B symptoms
      • Splenomegaly with spleen > 16 cm by CT scan
      • Evidence of compression syndrome (e.g., ureteral, orbital, gastrointestinal) or pleural or peritoneal serous effusion due to lymphoma (irrespective of cell content)
      • Leukemic presentation (≥ 5.0 x 10^9/L malignant circulating follicular cells)
      • Cytopenias (polymorphonuclear leukocytes < 1.0 X 10^9/L, hemoglobin < 10 g/dL, and/or platelets < 100 x 10^9/L)
    • Patient must have a FLIPI-1 score of 3, 4, or 5 (1 point per criterion below):

      • Age ≥ 60 years
      • Stage III-IV disease
      • Hemoglobin level < 12 g/dL
      • > 4 nodal areas
      • Serum LDH level above normal
  • At least 1 objective measurable disease parameter

    • Baseline measurements and evaluations (PET and CT) obtained within 6 weeks of randomization
    • Measurable disease in the liver is required if the liver is the only site of lymphoma

PATIENT CHARACTERISTICS:

  • See Disease Characteristics
  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm³ (includes neutrophils and bands)
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 2.0 mg/dL
  • AST and ALT ≤ 5 x upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 5 x ULN
  • Total bilirubin ≤ 1.5 x ULN (patients with known Gilbert disease should contact the study PI)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective methods (1 highly effective and 1 additional effective method) of contraception ≥ 28 days before, during, and for ≥ 28 days after completing study treatment
  • HIV-positive patients must meet all of the following criteria:

    • HIV is sensitive to antiretroviral therapy
    • Must be willing to take effective antiretroviral therapy if indicated
    • No history of CD4 < 300 cells/mm³ prior to or at the time of lymphoma diagnosis
    • No history of AIDS-defining conditions
    • If on antiretroviral therapy, must not be taking zidovudine or stavudine
    • Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP) during therapy and ≥ 2 months following completion of study therapy or until the CD4 cells recover to over 250 cells/mm³
  • No recent history of malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for ≥ 2 years
  • No active, uncontrolled infections (afebrile for > 48 hours off antibiotics)
  • No ≥ grade 2 neuropathy
  • No myocardial infarction within the past 6 months
  • No NYHA class III-IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • No serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • No known hypersensitivity to boron or mannitol
  • No chronic carriers of hepatitis B virus (HBV) with positive hepatitis surface antigen (HBsAg +)

    • Patients with a prior history of HBV infection, but immune, with only IgG hepatitis core antibody positive (HBcAb+), must receive antiviral prophylaxis (e.g., lamivudine 100 mg po daily) for ≥ 1 week prior to course 1 and throughout induction and continuation therapy and for ≥ 12 months after the last rituximab dose
  • Must register into the mandatory RevAssist® program and be willing and able to comply with the requirements of RevAssist® (for patients randomized to arm III)

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma

    • Prednisone or other corticosteroids used for non-lymphomatous conditions will not be considered as prior chemotherapy
    • A prior/recent short course (< 2 weeks) of steroids for symptom relief of lymphoma-related symptoms is allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01216683

  Hide Study Locations
Locations
United States, California
Marin Cancer Care Inc
Greenbrae, California, United States, 94904
Salinas Valley Memorial
Salinas, California, United States, 93901
Stanford University Hospitals and Clinics
Stanford, California, United States, 94305
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, United States, 80304
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, United States, 80220
Rose Medical Center
Denver, Colorado, United States, 80220
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80907
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, United States, 80113
Swedish Medical Center
Englewood, Colorado, United States, 80113
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Mountain Blue Cancer Care Center
Golden, Colorado, United States, 80401
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, United States, 80111
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, United States, 80228
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, United States, 80124
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Georgia Regents University Medical Center
Augusta, Georgia, United States, 30912
United States, Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States, 83706
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61701
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic
Centralia, Illinois, United States, 62801
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Carle on Vermilion
Danville, Illinois, United States, 61832
Cancer Care Center of Decatur
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Crossroads Cancer Center
Effingham, Illinois, United States, 62401
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States, 60521
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, United States, 61107
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Indiana
IU Health Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Ottumwa Regional Health Center
Ottumwa, Iowa, United States, 52501
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Ochsner Health Center-Summa
Baton Rouge, Louisiana, United States, 70809
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Dana-Farber Harvard Cancer Center
Boston, Massachusetts, United States, 02115
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, United States, 56601
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Missouri
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
United States, New Jersey
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, United States, 07018-1095
Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Cancer Institute of New Jersey At Hamilton
Hamilton, New Jersey, United States, 08690
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
United States, North Dakota
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota, United States, 58103
Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Sanford Clinic North-Fargo
Fargo, North Dakota, United States, 58122
Sanford Medical Center-Fargo
Fargo, North Dakota, United States, 58122
United States, Ohio
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Mercy Medical Center
Canton, Ohio, United States, 44708
Geaugra Hospital
Chardon, Ohio, United States, 44024
Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Ireland Cancer Center Landerbrook Health Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Southwest General Health Center Ireland Cancer Center
Middleburg Heights, Ohio, United States, 44130
UHHS-Chagrin Highlands Medical Center
Orange Village, Ohio, United States, 44122
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Flower Hospital
Sylvania, Ohio, United States, 43560
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
University Hospitals Sharon Health Center
Wadsworth, Ohio, United States, 44281
UH-Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio, United States, 44145
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States, 18201
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg, Pennsylvania, United States, 17837
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States, 17901
Hematology and Oncology Associates of North East Pennsylvania
Scranton, Pennsylvania, United States, 18508
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Dakota
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Vanderbilt-Ingram Cancer Center Cool Springs
Franklin, Tennessee, United States, 37067
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States, 54409
Fox Valley Hematology and Oncology
Appleton, Wisconsin, United States, 54911
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, United States, 54729
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Bellin Memorial Hospital
Green Bay, Wisconsin, United States, 54301
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311-6519
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States, 54143
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Oconomowoc Memorial Hospital-ProHealth Care Inc
Oconomowoc, Wisconsin, United States, 53066-3896
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States, 53081
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic
Two Rivers, Wisconsin, United States, 54241
Waukesha Memorial Hospital - ProHealth Care
Waukesha, Wisconsin, United States, 53188
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States, 54401
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Diagnostic and Treatment Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States, 54494
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Andrew M. Evens, DO, MS Robert H. Lurie Cancer Center
  More Information

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01216683     History of Changes
Other Study ID Numbers: E2408  E2408  NCI-2011-02644  CDR0000683312 
Study First Received: October 6, 2010
Last Updated: March 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:
contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lenalidomide
Rituximab
Thalidomide
Bortezomib
Bendamustine Hydrochloride
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 09, 2016