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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Eastern Cooperative Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT01216683
First received: October 6, 2010
Last updated: June 16, 2014
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
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
California Cancer Care, Incorporated - Greenbrae Recruiting
Greenbrae, California, United States, 94904
Contact: Peter D. Eisenberg, MD    415-925-5000      
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305-5824
Contact: Clinical Trials Office - Stanford Cancer Center    650-498-7061    cctoffice@stanford.edu   
United States, Colorado
Aurora Presbyterian Hospital Recruiting
Aurora, Colorado, United States, 80012
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Boulder Community Hospital Recruiting
Boulder, Colorado, United States, 80301-9019
Contact: Clinical Trials Office - Boulder Community Hospital    303-938-5253      
Penrose Cancer Center at Penrose Hospital Recruiting
Colorado Springs, Colorado, United States, 80933
Contact: Clinical Trials Office - Penrose Cancer Center    719-776-5275      
CCOP - Colorado Cancer Research Program Recruiting
Denver, Colorado, United States, 80222
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Presbyterian - St. Luke's Medical Center Recruiting
Denver, Colorado, United States, 80218
Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen    303-839-6000      
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Rose Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
St. Anthony Central Hospital Recruiting
Denver, Colorado, United States, 80204
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
St. Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80110
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Poudre Valley Hospital Recruiting
Fort Collins, Colorado, United States, 80524
Contact: Clinical Trials Office - Poudre Valley Hospital    970-495-8226      
North Colorado Medical Center Recruiting
Greeley, Colorado, United States, 80631
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Littleton Adventist Hospital Recruiting
Littleton, Colorado, United States, 80122
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Sky Ridge Medical Center Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Hope Cancer Care Center at Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Parker Adventist Hospital Recruiting
Parker, Colorado, United States, 80138
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
St. Mary - Corwin Regional Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
North Suburban Medical Center Recruiting
Thornton, Colorado, United States, 80229
Contact: Eduardo R. Pajon, MD    303-399-8020ext2261      
Exempla Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Clinical Trials Office - Exempla Lutheran Medical Center    303-403-3605      
United States, Delaware
CCOP - Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
Contact: Clinical Trial Office - CCOP - Christiana Care Health Services    302-623-4450      
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center    208-367-7954      
United States, Illinois
Rush-Copley Cancer Care Center Recruiting
Aurora, Illinois, United States, 60504
Contact: David L. Graham    630-499-2400      
St. Joseph Medical Center Recruiting
Bloomington, Illinois, United States, 61701
Contact: Nguyet A. Le-Lindqwister    309-662-3311      
Graham Hospital Recruiting
Canton, Illinois, United States, 61520
Contact: Nguyet A. Le-Lindqwister    309-647-5240      
Memorial Hospital Recruiting
Carthage, Illinois, United States, 62321
Contact: Nguyet A. Le-Lindqwister    217-357-3131      
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Clinical Trials Office - Rush University Medical Center    312-942-5498    clinical_trials@rush.edu   
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Recruiting
Chicago, Illinois, United States, 60611-3013
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer    312-695-1301    cancer@northwestern.edu   
Decatur Memorial Hospital Cancer Care Institute Recruiting
Decatur, Illinois, United States, 62526
Contact: Clinical Trials Office - Decatur Memorial Hospital Cancer Care    217-876-4750      
Eureka Community Hospital Recruiting
Eureka, Illinois, United States, 61530
Contact: Nguyet A. Le-Lindqwister    309-467-2371      
Galesburg Clinic, PC Recruiting
Galesburg, Illinois, United States, 61401
Contact: Nguyet A. Le-Lindqwister    309-344-1000      
Hinsdale Hematology Oncology Associates Recruiting
Hinsdale, Illinois, United States, 60521
Contact: Elyse C. Schneiderman, MD    630-654-1790      
McDonough District Hospital Recruiting
Macomb, Illinois, United States, 61455
Contact: Nguyet A. Le-Lindqwister    309-833-4101      
Cancer Care and Hematology Specialists of Chicagoland - Niles Recruiting
Niles, Illinois, United States, 60714
Contact: Jane N. Winter, MD    312-695-4538      
BroMenn Regional Medical Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-454-1400      
Community Cancer Center Recruiting
Normal, Illinois, United States, 61761
Contact: Nguyet A. Le-Lindqwister    309-451-8500      
Community Hospital of Ottawa Recruiting
Ottawa, Illinois, United States, 61350
Contact: Nguyet A. Le-Lindqwister    815-433-3100      
Cancer Treatment Center at Pekin Hospital Recruiting
Pekin, Illinois, United States, 61554
Contact: Nguyet A. Le-Lindqwister    309-353-0512      
Oncology Hematology Associates of Central Illinois, PC - Peoria Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3000      
OSF St. Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
Contact: Nguyet A. Le-Lindqwister    309-655-2000      
Proctor Hospital Recruiting
Peoria, Illinois, United States, 61614
Contact: Nguyet A. Le-Lindqwister    309-691-1000      
CCOP - Illinois Oncology Research Association Recruiting
Peoria, Illinois, United States, 61615
Contact: Nguyet A. Le-Lindqwister    309-243-3605      
Methodist Medical Center of Illinois Recruiting
Peoria, Illinois, United States, 61636
Contact: Clinical Trials Office - Methodist Medical Center of Illinois    309-243-3000      
Illinois Valley Community Hospital Recruiting
Peru, Illinois, United States, 61354
Contact: Nguyet A. Le-Lindqwister    815-223-3000      
Swedish-American Regional Cancer Center Recruiting
Rockford, Illinois, United States, 61104-2315
Contact: Clinical Trials Office - Swedish-American Regional Cancer Cent    815-489-4413      
Regional Cancer Center at Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781-0001
Contact: Clinical Trials Office - Regional Cancer Center at Memorial Me    217-788-4233      
CCOP - Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Clinical Trials Office - CCOP - Carle Cancer Center    800-446-5532      
United States, Indiana
Clarian Arnett Cancer Care Recruiting
Lafayette, Indiana, United States, 47904
Contact: Thomas I. Jones, MD    765-448-7500      
Horizon Oncology Center Recruiting
Lafayette, Indiana, United States, 47905
Contact: Wael A. Harb    765-446-5111      
Saint Anthony Memorial Health Centers Recruiting
Michigan City, Indiana, United States, 46360
Contact: David L. Graham    219-879-8511      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
McCreery Cancer Center at Ottumwa Regional Recruiting
Ottumwa, Iowa, United States, 52501
Contact: Robert J. Behrens    641-684-2946      
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51102
Contact: Donald B. Wender, MD, PhD    712-252-0088      
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD    712-252-0088      
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Kansas
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Wesley Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
United States, Maryland
Greater Baltimore Medical Center Cancer Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Clinical Trials Office - Greater Baltimore Medical Center Canc    443-849-3706      
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Andrew M. Evens    508-856-0011      
United States, Michigan
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Christopher M. Reynolds    734-712-5658      
Bronson Methodist Hospital Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Raymond S. Lord, MD    269-373-7458      
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007-3731
Contact: Clinical Trials Office - West Michigan Cancer Center    269-373-7458      
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD    269-373-7458      
United States, Minnesota
MeritCare Bemidji Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Preston D. Steen, MD    701-234-2397      
St. Joseph's Medical Center Recruiting
Brainerd, Minnesota, United States, 56401
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
Fairview Ridges Hospital Recruiting
Burnsville, Minnesota, United States, 55337
Contact: Joseph W. Leach    952-892-2000      
Mercy and Unity Cancer Center at Mercy Hospital Recruiting
Coon Rapids, Minnesota, United States, 55433
Contact: Joseph W. Leach    763-236-6000      
Duluth Clinic Cancer Center - Duluth Recruiting
Duluth, Minnesota, United States, 55805-1983
Contact: Clinical Trials Office - Duluth Clinic Cancer Center - Duluth    218-786-3308      
CCOP - Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
Miller - Dwan Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Clinical Trials Office - Fairview Southdale Hospital    612-625-3650      
Mercy and Unity Cancer Center at Unity Hospital Recruiting
Fridley, Minnesota, United States, 55432
Contact: Joseph W. Leach    763-236-5000      
Hutchinson Area Health Care Recruiting
Hutchinson, Minnesota, United States, 55350
Contact: Joseph W. Leach    320-234-5000      
Minnesota Oncology - Maplewood Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Joseph W. Leach    651-779-7978      
HealthEast Cancer Care at St. John's Hospital Recruiting
Maplewood, Minnesota, United States, 55109
Contact: Joseph W. Leach    651-232-7970      
Hennepin County Medical Center - Minneapolis Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Clinical Trials Office - Hennepin County Medical Center - Minn    612-873-5911      
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Clinical Trials Office - Virginia Piper Cancer Institute    612-863-5654      
Humphrey Cancer Center at North Memorial Outpatient Center Recruiting
Robbinsdale, Minnesota, United States, 55422-2900
Contact: Clinical Trials Office - Humphrey Cancer Center at North Memor    763-520-1893      
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Joseph W. Leach    952-993-3248      
CCOP - Metro-Minnesota Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Joseph W. Leach    952-993-1517      
United Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Joseph W. Leach    651-241-8000      
St. Francis Cancer Center at St. Francis Medical Center Recruiting
Shakopee, Minnesota, United States, 55379
Contact: Joseph W. Leach    952-403-2031      
Regions Hospital Cancer Care Center Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Clinical Trials Office - Regions Hospital Cancer Care Center    651-254-1517      
Lakeview Hospital Recruiting
Stillwater, Minnesota, United States, 55082
Contact: Joseph W. Leach    651-439-5330      
Ridgeview Medical Center Recruiting
Waconia, Minnesota, United States, 55387
Contact: Joseph W. Leach    952-442-2191      
Willmar Cancer Center at Rice Memorial Hospital Recruiting
Willmar, Minnesota, United States, 56201
Contact: Joseph W. Leach    320-231-4650      
Minnesota Oncology - Woodbury Recruiting
Woodbury, Minnesota, United States, 55125
Contact: Joseph W. Leach    651-735-7414      
United States, New Jersey
Veterans Affairs Medical Center - East Orange Recruiting
East Orange, New Jersey, United States, 07018-1095
Contact: Basil S. Kasimis, MD, DSc    973-395-7809      
Hunterdon Regional Cancer Center at Hunterdon Medical Center Recruiting
Flemington, New Jersey, United States, 08822
Contact: Kenneth B. Blankstein, MD    908-788-6100      
Cancer Institute of New Jersey at Hamilton Recruiting
Hamilton, New Jersey, United States, 08690
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Ham    609-631-6946      
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton Recruiting
Marlton, New Jersey, United States, 08053
Contact: Clinical Trials Office - Fox Chase Virtua Health Cancer Progra    888-847-8823      
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey    732-235-8675      
UMDNJ University Hospital Recruiting
Newark, New Jersey, United States, 07103
Contact: Lillian F. Pliner, MD, FACP    973-972-6257      
United States, New York
NYU Cancer Institute at New York University Medical Center Recruiting
New York, New York, United States, 10016
Contact: Bruce G. Raphael, MD    212-731-5185      
United States, North Dakota
CCOP - MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD    701-234-2397      
Dakota Cancer Institute at Dakota Clinic - South University Recruiting
Fargo, North Dakota, United States, 58103
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
Roger Maris Cancer Center at MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD    701-234-2397      
United States, Ohio
Summa Center for Cancer Care at Akron City Hospital Recruiting
Akron, Ohio, United States, 44309-2090
Contact: Clinical Trials Office - Akron City Hospital    330-375-6101      
Wood County Oncology Center Recruiting
Bowling Green, Ohio, United States, 43402
Contact: Rex B. Mowat    419-352-9498      
Aultman Cancer Center at Aultman Hospital Recruiting
Canton, Ohio, United States, 44710-1799
Contact: Clinical Trials Office - Aultman Cancer Center at Aultman Hosp    330-363-6891      
Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center    800-641-2422      
MetroHealth Cancer Care Center at MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Bruce J. Averbook, MD, FACS    216-778-4795      
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Toledo Clinic - Oregon Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex B. Mowat    419-691-4235      
Toledo Clinic, Incorporated - Main Clinic Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex B. Mowat    419-479-5605      
CCOP - Toledo Community Hospital Recruiting
Toledo, Ohio, United States, 43617
Contact: Rex B. Mowat    419-843-6147      
United States, Pennsylvania
Bryn Mawr Hospital Recruiting
Bryn Mawr, Pennsylvania, United States, 19010
Contact: Clinical Trials Office - Bryn Mawr Hospital    610-645-2680      
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute    570-271-5251      
Geisinger Hazleton Cancer Center Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Edward J. Gorak, II    570-459-2901      
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact: Clinical Trials Office - Penn State Hershey Cancer Institute a    717-531-3779    CTO@hmc.psu.edu   
Lewistown Hospital Recruiting
Lewistown, Pennsylvania, United States, 17044
Contact: Elliot M. Epner, MD, PhD    503-494-1551      
Cancer Center of Paoli Memorial Hospital Recruiting
Paoli, Pennsylvania, United States, 19301-1792
Contact: Clinical Trials Office - Cancer Center of Paoli Memorial Hospi    610-648-1637      
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer    215-955-6084      
Joan Karnell Cancer Center at Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Lee Hartner    215-829-3000      
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center Recruiting
Reading, Pennsylvania, United States, 19612-6052
Contact: Clinical Trials Office - McGlinn Family Regional Cancer Center    610-988-9323      
Hematology and Oncology Associates of Northeastern Pennsylvania Recruiting
Scranton, Pennsylvania, United States, 18508
Contact: Elena Gitelson    570-342-3675      
Mount Nittany Medical Center Recruiting
State College, Pennsylvania, United States, 16803
Contact: Elliot M. Epner, MD, PhD    503-494-1551      
Geisinger Medical Group - Scenery Park Recruiting
State College, Pennsylvania, United States, 16801
Contact: Edward J. Gorak, II    814-231-4560      
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce    570-271-5251      
Lankenau Cancer Center at Lankenau Hospital Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Paul B. Gilman, MD    610-645-2000      
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57117-5039
Contact: Clinical Trials Office - Sanford Cancer Center    605-328-1367      
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
United States, West Virginia
West Virginia University Health Sciences Center - Charleston Recruiting
Charleston, West Virginia, United States, 25304
Contact: Steven J. Jubelirer, MD    304-388-8380      
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Mehdi Hamadani    304-293-4500      
United States, Wisconsin
Langlade Memorial Hospital Recruiting
Antigo, Wisconsin, United States, 54409
Contact: Hamied R. Rezazadeh, MD    715-847-2121      
Fox Valley Hematology and Oncology - East Grant Street Recruiting
Appleton, Wisconsin, United States, 54911-3496
Contact: Avi Bar-Lev    920-749-1171      
Marshfield Clinic - Chippewa Center Recruiting
Chippewa Falls, Wisconsin, United States, 54729
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic Cancer Care at Regional Cancer Center Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Ali W. Bseiso, MD    715-387-5416      
Bellin Memorial Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Patrick J. Mansky    920-433-3500      
St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54307-3508
Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer    920-433-8889      
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic - Green    414-649-5717      
UW Cancer Center Johnson Creek Recruiting
Johnson Creek, Wisconsin, United States, 53038
Contact: Brad S. Kahl, MD    608-263-1836      
Gundersen Lutheran Center for Cancer and Blood Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Clinical Trials Office - Gundersen Lutheran Cancer Center    608-775-2385    cancerctr@gundluth.org   
Dean Medical Center - Madison Recruiting
Madison, Wisconsin, United States, 53717
Contact: Amit Sanyal    608-252-8000      
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Recruiting
Madison, Wisconsin, United States, 53792-6164
Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo    608-262-5223      
Vince Lombardi Cancer Clinic - Marinette Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Dhimant R. Patel, MD    920-288-4180      
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center    800-782-1581 ext. 94457      
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C    414-805-4380      
Marshfield Clinic - Lakeland Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Ali W. Bseiso, MD    715-387-5416      
Regional Cancer Center at Oconomowoc Memorial Hospital Recruiting
Oconomowoc, Wisconsin, United States, 53066
Contact: Clinical Trials Office - Regional Cancer Center at Oconomowoc    262-928-7878      
Vince Lombardi Cancer Clinic - Oshkosh Recruiting
Oshkosh, Wisconsin, United States, 54904
Contact: Dhimant R. Patel, MD    920-288-4180      
Ministry Medical Group at Saint Mary's Hospital Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic - Indianhead Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Ali W. Bseiso, MD    715-387-5416      
Vince Lombardi Cancer Clinic - Sheboygan Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic - Sheboy    414-649-7200      
Marshfield Clinic at Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Ali W. Bseiso, MD    715-387-5416      
Aurora Medical Center Recruiting
Summit, Wisconsin, United States, 53066
Contact: Dhimant R. Patel, MD    920-288-4180      
Vince Lombardi Cancer Clinic - Two Rivers Recruiting
Two Rivers, Wisconsin, United States, 54241
Contact: Dhimant R. Patel, MD    920-288-4180      
Waukesha Memorial Hospital Regional Cancer Center Recruiting
Waukesha, Wisconsin, United States, 53188
Contact: Clinical Trials Office - Waukesha Memorial Hospital Regional C    262-928-7632      
University of Wisconcin Cancer Center at Aspirus Wausau Hospital Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Clinical Trials Office - University of Wisconsin Cancer Center    608-262-5223      
Oncology Alliance, SC - Milwaukee - West Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Rubina Qamar    414-476-8450      
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Ali W. Bseiso, MD    715-387-5416      
Marshfield Clinic - Wisconsin Rapids Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Ali W. Bseiso, MD    715-387-5416      
Riverview UW Cancer Center at Riverview Hospital Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Ron J. Kirschling, MD, FACP    715-421-7442      
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Andrew M. Evens, DO, MS Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01216683     History of Changes
Other Study ID Numbers: CDR0000683312, E2408, NCI-2011-02644
Study First Received: October 6, 2010
Last Updated: June 16, 2014
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
Bendamustine
Rituximab
Bortezomib
Lenalidomide
Nitrogen Mustard Compounds
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Protease Inhibitors
Enzyme Inhibitors
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 23, 2014