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Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell 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:
NCT01415752
First received: August 11, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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

PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.


Condition Intervention Phase
Lymphoma
Neurotoxicity
Therapy-related Toxicity
Biological: rituximab
Drug: bendamustine hydrochloride
Drug: bortezomib
Drug: lenalidomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intergroup Randomized Phase 2 Four Arm Study In Patients ≥ 60 With Previously Untreated Mantle Cell Lymphoma Of Therapy With: Arm A = Rituximab+ Bendamustine Followed By Rituximab Consolidation (RB → R); Arm B = Rituximab + Bendamustine + Bortezomib Followed By Rituximab Consolidation (RBV→ R), Arm C = Rituximab + Bendamustine Followed By Lenalidomide + Rituximab Consolidation (RB → LR) or Arm D = Rituximab + Bendamustine + Bortezomib Followed By Lenalidomide + Rituximab Consolidation (RBV → LR)

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • 2-year PFS rate of patients treated with RBV to an induction regimen of RB compared to RB alone [ Designated as safety issue: No ]
  • PFS improvement of patients treated with lenalidomide added to a consolidation regimen [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PET-documented CR rate [ Designated as safety issue: No ]
  • Response rate to RB and RBV [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Designated as safety issue: No ]

Estimated Enrollment: 332
Study Start Date: May 2012
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Patients receive induction therapy comprising rituximab IV on day 1 and bendamustine hydrochloride IV over 60 minutes on days 1-2. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm E.
Biological: rituximab
Given IV
Drug: bendamustine hydrochloride
Given IV
Experimental: Arm B
Patients receive induction therapy comprising bortezomib IV subcutaneously (SC) on days 1, 4, 8, and 11 and rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm F.
Biological: rituximab
Given IV
Drug: bendamustine hydrochloride
Given IV
Drug: bortezomib
Given IV or SC
Experimental: Arm C
Patients receive induction therapy comprising rituximab and bendamustine hydrochloride as patients in arm A. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm G.
Biological: rituximab
Given IV
Drug: bendamustine hydrochloride
Given IV
Drug: lenalidomide
Given PO
Experimental: Arm D
Patients receive bortezomib, rituximab, and bendamustine hydrochloride as patients in arm B. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to arm H.
Biological: rituximab
Given IV
Drug: bendamustine hydrochloride
Given IV
Drug: bortezomib
Given IV or SC
Drug: lenalidomide
Given PO
Experimental: Arm E
Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Given IV
Experimental: Arm F
Patients receive consolidation therapy comprising rituximab IV on day 1. Courses repeat every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Given IV
Experimental: Arm G
Patients receive consolidation therapy comprising lenalidomide orally (PO) daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Given IV
Drug: lenalidomide
Given PO
Experimental: Arm H
Patients receive consolidation therapy comprising lenalidomide PO daily on days 1-21 every 4 weeks and rituximab IV every 8 weeks for 2 years in the absence of disease progression or unacceptable toxicity.
Biological: rituximab
Given IV
Drug: lenalidomide
Given PO

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH)
  • Patients must have at least one objective measurable disease parameter

    • Abnormal PET scans will not constitute evaluable disease, unless verified by CT scan or other appropriate imaging
    • Measurable disease in the liver is required if the liver is the only site of lymphoma
  • Patient must have no CNS involvement

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • ANC ≥ 1,500/mcL (1.5 x 10^9/L)*
  • Platelets ≥ 100,000/mcL (100 x 10^9/L)* NOTE: *Unless due to marrow involvement.
  • AST/ALT ≤ 2 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN
  • Calculated creatinine clearance by Cockroft-Gault formula ≥ 30 mL/min
  • Women (sexually mature female) must not be pregnant or breast-feeding
  • Negative pregnancy test
  • Women of childbearing potential and sexually active males use an accepted and effective method of contraception

    • Men must agree to use a latex condom during sexual contact with a female of child-bearing potential, even if they have had a successful vasectomy
    • All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure
  • No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically or radiation-cured malignancy continuously disease free for ≥ 5 years so as not to interfere with interpretation of radiographic response
  • Patient agrees that if randomized to Arms C or D, and proceed onto Arms G or H, they must register into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®

    • Patients must have no medical contra-indications to, and be willing to take, deep vein thrombosis (DVT) prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have DVT prophylaxis

      • Patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have therapeutic doses of low-molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0
      • Patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis

        • Patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment
    • Women must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatment
    • Males must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatment
  • HIV-positive patients are not excluded but, to enroll, must meet all of the below criteria:

    • HIV is sensitive to antiretroviral therapy
    • Must be willing to take effective antiretroviral therapy, if indicated
    • No history of CD4 prior to or at the time of lymphoma diagnosis < 300 cells/mm³
    • 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 until at least 2 months following the completion of therapy or until the CD4 cells recover to over 250 cells/mm³, whichever occurs later
  • Patients must not have grade 2 or greater peripheral neuropathy
  • Patients must not have NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
  • Patients must not have hypersensitivity to bortezomib, boron, or mannitol
  • Patients must not have a serious medical or psychiatric illness likely to interfere with study participation

PRIOR CONCURRENT THERAPY:

  • No prior therapy for MCL, except < 1 week of steroid therapy for symptom control
  • HIV-positive patients are not excluded, but to enroll, must meet all of the below criteria:

    • Must be willing to take effective antiretroviral therapy if indicated
    • If on antiretroviral therapy, must not be taking zidovudine or stavudine
  • Patients must not be participating in any other clinical trial or taking any other experimental medications within 14 days prior to registration
  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: NCT01415752

  Hide Study Locations
Locations
United States, California
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    303-399-8020      
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    303-399-8020 ext 2261      
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
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      
St. Anthony Central Hospital Recruiting
Denver, Colorado, United States, 80204
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Rose Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
St. Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80110
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
North Colorado Medical Center Recruiting
Greeley, Colorado, United States, 80631
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Littleton Adventist Hospital Recruiting
Littleton, Colorado, United States, 80122
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Sky Ridge Medical Center Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Hope Cancer Care Center at Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Parker Adventist Hospital Recruiting
Parker, Colorado, United States, 80138
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
St. Mary - Corwin Regional Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Eduardo R. Pajon, MD    303-399-8020 ext 2261      
Exempla Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Clinical Trials Office - Exempla Lutheran Medical Center    303-403-3605      
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella, MD    734-712-1000      
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center Recruiting
Lewes, Delaware, United States, 19958
Contact: Clinical Trials Office - Tunnell Cancer Center    302-645-3171      
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, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center Recruiting
Washington, District of Columbia, United States, 20007
Contact: Clinical Trials Office - Lombardi Comprehensive Cancer Center    202-444-0381      
United States, Florida
Baptist Cancer Institute - Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
Contact: Clinical Trials Office - Baptist Cancer Institute - Jacksonvil    904-202-7051      
United States, Hawaii
Oncare Hawaii, Incorporated - Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Kapiolani Medical Center at Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Cancer Research Center of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Clinical Trials Office - Cancer Research Center of Hawaii    808-586-2979      
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
OnCare Hawaii, Incorporated - Kuakini Recruiting
Honolulu, Hawaii, United States, 96817-3169
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Straub Clinic and Hospital, Incorporated Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
OnCare Hawaii, Incorporated - Lusitana Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Queen's Cancer Institute at Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Castle Medical Center Recruiting
Kailua, Hawaii, United States, 96734
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Kauai Medical Clinic Recruiting
Lihue, Hawaii, United States, 96766
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
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      
Idaho Urologic Institute, PA Recruiting
Meridian, Idaho, United States, 83642
Contact: Philip J. Stella, MD    734-712-1000      
United States, Illinois
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   
Hematology and Oncology Associates Recruiting
Chicago, Illinois, United States, 60611
Contact: Clinical Trails Office - Hematology and Oncology Associates    312-695-1301      
Kellogg Cancer Care Center Recruiting
Highland Park, Illinois, United States, 60035
Contact: Jane N. Winter, MD    312-695-4538      
Provena St. Mary's Regional Cancer Center - Kankakee Recruiting
Kankakee, Illinois, United States, 60901
Contact: Jane N. Winter, MD    312-695-4538      
North Shore Oncology and Hematology Associates, Limited - Libertyville Recruiting
Libertyville, Illinois, United States, 60048
Contact: Jane N. Winter, MD    312-695-4538      
Good Samaritan Regional Health Center Recruiting
Mount Vernon, Illinois, United States, 62864
Contact: Bethany G. Sleckman, MD    314-251-7057      
Cancer Care and Hematology Specialists of Chicagoland - Niles Recruiting
Niles, Illinois, United States, 60714
Contact: Jane N. Winter, MD    312-695-4538      
Swedish-American Regional Cancer Center Recruiting
Rockford, Illinois, United States, 61104-2315
Contact: Clinical Trials Office - Swedish-American Regional Cancer Cent    815-489-4413      
Hematology Oncology Associates - Skokie Recruiting
Skokie, Illinois, United States, 60076
Contact: Jane N. Winter, MD    312-695-4538      
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Howard M. Gross, MD    937-832-1093      
Clarian Arnett Cancer Care Recruiting
Lafayette, Indiana, United States, 47904
Contact: Thomas I. Jones, MD    765-448-7500      
Reid Hospital & Health Care Services Recruiting
Richmond, Indiana, United States, 47374
Contact: Howard M. Gross, MD    937-832-1093      
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC    515-239-2621      
Cedar Rapids Oncology Associates Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Clinical Trials Office - Cedar Rapids Oncology Associates    319-363-2690      
Mercy Regional Cancer Center at Mercy Medical Center Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah W. Wilbur    319-398-6011      
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      
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51102
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Maine
Harold Alfond Center for Cancer Care Recruiting
Augusta, Maine, United States, 04330
Contact: Thomas H. Openshaw    207-621-6100      
CancerCare of Maine at Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Clinical Trials Office - CancerCare of Maine    207-973-4274      
United States, Maryland
Union Hospital of Cecil County Recruiting
Elkton MD, Maryland, United States, 21921
Contact: Gregory A. Masters, MD    302-366-1200      
United States, Michigan
CCOP - Michigan Cancer Research Consortium Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella, MD    734-712-1000      
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella, MD    734-712-1000      
Oakwood Cancer Center at Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48123-2500
Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp    313-593-8090      
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201-1379
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute    313-576-9363      
Green Bay Oncology, Limited - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Gerald K. Bayer, MD    920-432-6049      
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center    810-762-8057      
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Genesys Hurley Cancer Institute    810-762-8057      
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Philip J. Stella, MD    734-712-1000      
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo    313-343-3166      
Dickinson County Healthcare System Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Gerald K. Bayer, MD    920-432-6049      
Foote Memorial Hospital Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella, MD    734-712-1000      
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49001
Contact: Raymond S. Lord, MD    269-373-7458      
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      
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48912-1811
Contact: Clinical Trials Office - Sparrow Regional Cancer Center    517-364-2890      
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella, MD    734-712-1000      
St. Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella, MD    734-712-1000      
Mercy Regional Cancer Center at Mercy Hospital Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella, MD    734-712-1000      
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw    989-776-8411      
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella, MD    734-712-1000      
United States, Minnesota
MeritCare Bemidji Recruiting
Bemidji, Minnesota, United States, 56601
Contact: Preston D. Steen, MD    701-234-2397      
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      
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      
New Ulm Medical Center Recruiting
New Ulm, Minnesota, United States, 56073
Contact: Joseph W. Leach    507-217-5000      
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      
CCOP - Metro-Minnesota Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Joseph W. Leach    952-993-1517      
Park Nicollet Cancer Center Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Joseph W. Leach    952-993-3248      
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, Missouri
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Alan P. Lyss, MD    314-996-5514      
Saint Francis Medical Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Bethany G. Sleckman, MD    314-251-7057      
Ellis Fischel Cancer Center at University of Missouri - Columbia Recruiting
Columbia, Missouri, United States, 65203
Contact: Clinical Trial Office - Ellis Fischel Cancer Center    573-882-7440      
Goldschmidt Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Alan P. Lyss, MD    314-996-5514      
Phelps County Regional Medical Center Recruiting
Rolla, Missouri, United States, 65401
Contact: Robert L. Carolla    573-458-8899      
Mercy Clinic Cancer and Hematology - Rolla Recruiting
Rolla, Missouri, United States, 65401
Contact: Robert L. Carolla    573-458-6379      
CCOP - St. Louis-Cape Girardeau Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Bethany G. Sleckman, MD    314-251-7057      
Midwest Hematology Oncology Group, Incorporated Recruiting
Saint Louis, Missouri, United States, 63109
Contact: Bethany G. Sleckman, MD    314-251-7057      
David C. Pratt Cancer Center at St. John's Mercy Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Clinical Trials Office - David C. Pratt Cancer Center at St. J    314-251-6770      
Missouri Baptist Cancer Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Alan P. Lyss, MD    314-996-5514      
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Nancy L. Bartlett, MD    314-362-5654      
Hulston Cancer Center at Cox Medical Center South Recruiting
Springfield, Missouri, United States, 65807
Contact: Robert L. Carolla    417-269-5257      
CCOP - Cancer Research for the Ozarks Recruiting
Springfield, Missouri, United States, 65802
Contact: Robert L. Carolla    417-269-4520      
St. John's Regional Health Center Recruiting
Springfield, Missouri, United States, 65804
Contact: Robert L. Carolla    417-820-2000      
United States, Montana
St. Vincent Healthcare Cancer Care Services Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Hematology-Oncology Centers of the Northern Rockies - Billings Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin T. Marchello, MD    406-238-6290      
CCOP - Montana Cancer Consortium Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello, MD    406-238-6290      
Billings Clinic - Downtown Recruiting
Billings, Montana, United States, 59107-7000
Contact: Clinical Trials Office - Billings Clinic - Downtown    800-996-2663    research@billingsclinic.org   
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. James Healthcare Cancer Care Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello, MD    406-238-6290      
Great Falls Clinic - Main Facility Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
Sletten Cancer Institute at Benefis Healthcare Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello, MD    406-238-6290      
St. Peter's Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello, MD    406-238-6290      
Kalispell Medical Oncology at KRMC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Glacier Oncology, PLLC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Recruiting
Missoula, Montana, United States, 59807
Contact: Clinical Trials Office - Montana Cancer Center at St. Patrick    406-329-7029      
Montana Cancer Specialists at Montana Cancer Center Recruiting
Missoula, Montana, United States, 59807-7877
Contact: Clinical Trials Office - Montana Cancer Specialists at Montana    406-238-6962      
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Coo    856-325-6757      
United States, New York
CCOP - Hematology-Oncology Associates of Central New York Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey J. Kirshner, MD    315-472-7504      
Charles R. Wood Cancer Center at Glens Falls Hospital Recruiting
Glens Falls, New York, United States, 12801
Contact: Clinical Trials Office - Charles R. Wood Cancer Center at Glen    518-926-6700      
Tucker Center for Cancer Care at Orange Regional Medical Center Recruiting
Middletown, New York, United States, 10940-4199
Contact: Clinical Trials Office - Tucker Center for Cancer Care at Oran    845-342-7609      
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center    212-746-1848      
James P. Wilmot Cancer Center at University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Jonathan W. Friedberg    585-275-5345      
United States, North Carolina
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD    919-580-0000      
Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: James E. Radford, MD    828-692-8045      
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD    252-559-2200 ext 201      
Iredell Memorial Hospital Recruiting
Statesville, North Carolina, United States, 28677
Contact: Ruby A. Grimm, MD    704-873-2219      
United States, North Dakota
CCOP - MeritCare Hospital Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen, MD    701-234-2397      
MeritCare Broadway Recruiting
Fargo, North Dakota, United States, 58102
Contact: Preston D. Steen, MD    701-234-2397      
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      
Barberton Citizens Hospital Recruiting
Barberton, Ohio, United States, 44203
Contact: Jennifer E. Payne    330-745-1611      
Cleveland Clinic Beachwood Family Health and Surgery Center Recruiting
Beachwood, Ohio, United States, 44122
Contact: Anjali S. Advani    216-839-3200      
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 Cancer Center at Fairview Hospital Recruiting
Cleveland, Ohio, United States, 44111
Contact: Clinical Trials Office - Cleveland Clinic Cancer Center at Fai    216-476-9362      
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente    866-223-8100      
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210-1240
Contact: Ohio State University Cancer Clinical Trial Matching Service    866-627-7616    Jamesline@osumc.edu   
David L. Rike Cancer Center at Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami    937-208-2079      
CCOP - Dayton Recruiting
Dayton, Ohio, United States, 45420
Contact: Howard M. Gross, MD    937-832-1093      
Good Samaritan Hospital Recruiting
Dayton, Ohio, United States, 45406
Contact: Howard M. Gross, MD    937-832-1093      
Samaritan North Cancer Care Center Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard M. Gross, MD    937-832-1093      
Grandview Hospital Recruiting
Dayton, Ohio, United States, 45405
Contact: Howard M. Gross, MD    937-832-1093      
Blanchard Valley Medical Associates Recruiting
Findlay, Ohio, United States, 45840
Contact: Howard M. Gross, MD    937-832-1093      
Middletown Regional Hospital Recruiting
Franklin, Ohio, United States, 45005-1066
Contact: Howard M. Gross, MD    937-832-1093      
Wayne Hospital Recruiting
Greenville, Ohio, United States, 45331
Contact: Howard M. Gross, MD    937-832-1093      
Cleveland Clinic Cancer Center Recruiting
Independence, Ohio, United States, 44131
Contact: Anjali S. Advani    216-524-7979      
Charles F. Kettering Memorial Hospital Recruiting
Kettering, Ohio, United States, 45429
Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita    937-298-3399 ext 57556      
Hillcrest Cancer Center at Hillcrest Hospital Recruiting
Mayfield Heights, Ohio, United States, 44124
Contact: Anjali S. Advani    440-312-4500      
Parma Community General Hospital Recruiting
Parma, Ohio, United States, 44129
Contact: Clinical Trials Office - Parma Community General Hospital    440-743-4747      
North Coast Cancer Care, Incorporated Recruiting
Sandusky, Ohio, United States, 44870
Contact: Anjali S. Advani    419-626-9090      
Cleveland Clinic Foundation - Strongsville Recruiting
Strongsville, Ohio, United States, 44136
Contact: Anjali S. Advani    440-878-2500      
UVMC Cancer Care Center at Upper Valley Medical Center Recruiting
Troy, Ohio, United States, 45373-1300
Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall    937-440-4842      
Cleveland Clinic - Wooster Recruiting
Wooster, Ohio, United States, 44691
Contact: Clinical Trials Office - Cleveland Clinic - Wooster    800-862-7798      
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Recruiting
Xenia, Ohio, United States, 45385
Contact: Howard M. Gross, MD    937-832-1093      
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi    215-728-4790      
Pottstown Memorial Regional Cancer Center Recruiting
Pottstown, Pennsylvania, United States, 19464
Contact: Wei Song, MD, PhD    610-327-7555      
United States, Tennessee
Wellmont-Bristol Regional Medical Center Recruiting
Bristol, Tennessee, United States, 37620
Contact: Asheesh Shipstone    423-844-2360      
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center Recruiting
Kingsport, Tennessee, United States, 37662
Contact: Clinical Trials Office - Christine LaGuardia Phillips Cancer C    423-224-5593      
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Michael E. Williams, MD    434-924-9637      
Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County Recruiting
Martinsville, Virginia, United States, 24115
Contact: Sreedhar Katragadda    276-666-7200      
Southwest Virginia Regional Cancer Center at Wellmonth Health Recruiting
Norton, Virginia, United States, 24273
Contact: Asheesh Shipstone    540-679-5874      
United States, West Virginia
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      
St. Mary's Hospital Medical Center - Green Bay Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Gerald K. Bayer, MD    920-432-6049      
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      
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Gerald K. Bayer, MD    920-432-6049      
Green Bay Oncology, Limited at St. Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Gerald K. Bayer, MD    920-432-6049      
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   
Holy Family Memorial Medical Center Cancer Care Center Recruiting
Manitowoc, Wisconsin, United States, 54221-1450
Contact: Clinical Trials Office - Holy Family Memorial Medical Center C    920-320-2749      
Bay Area Cancer Care Center at Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Gerald K. Bayer, MD    920-432-6049      
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      
D.N. Greenwald Center Recruiting
Mukwonago, Wisconsin, United States, 53149
Contact: Michael A. Thompson    262-363-1916      
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      
Green Bay Oncology, Limited - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Gerald K. Bayer, MD    920-432-6049      
St. Nicholas Hospital Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Gerald K. Bayer, MD    920-432-6049      
Green Bay Oncology, Limited - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Gerald K. Bayer, MD    920-432-6049      
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      
United States, Wyoming
Rocky Mountain Oncology Recruiting
Casper, Wyoming, United States, 82609
Contact: Benjamin T. Marchello, MD    406-238-6290      
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Mitchell R. Smith, MD, PhD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT01415752     History of Changes
Other Study ID Numbers: CDR0000707057, ECOG-E1411
Study First Received: August 11, 2011
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eastern Cooperative Oncology Group:
neurotoxicity
therapy-related toxicity
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage I mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Neurotoxicity Syndromes
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nervous System Diseases
Poisoning
Chemically-Induced Disorders
Rituximab
Lenalidomide
Bortezomib
Bendamustine
Thalidomide
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 22, 2014