Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma

May 8, 2026 updated by: Eastern Cooperative Oncology Group

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

To determine whether the addition of bortezomib (RBV) to an induction regimen of rituximab-bendamustine (RB) improves progression-free survival (PFS) compared to RB alone in patients with previously untreated mantle cell lymphoma.
To determine whether the addition of lenalidomide to a consolidation regimen of rituximab following an induction regimen of RB or RBV improves PFS compared to consolidation rituximab alone in this patient population.

Secondary

To determine whether the addition of bortezomib to induction therapy improves the positron emission tomography (PET)-documented complete response (CR) rate compared to RB alone.
To determine the objective response rate (ORR) for RB and RBV.
Among patients who do not have PET-documented CR at the end of induction, to determine whether the addition of lenalidomide to consolidation therapy improves CR and ORR compared with rituximab alone.
To determine overall survival (OS) in the treatment arms.
To determine safety, with attention to the addition of bortezomib in the induction regimen and lenalidomide-rituximab (LR) as consolidation therapy.

Laboratory

To collect paraffin-embedded tissue for creation of tissue microarray.
To collect and bank serum and blood mononuclear cells for future studies.
To collect formalin-fixed paraffin-embedded (FFPE) tissue to analyze potential prognostic factors (Ki-67 proliferation index by immunohistochemistry and correlation with proposed 5-gene set of proliferation markers analyzed by RNA PCR; SOX 11 expression by immunohistochemistry; and Micro-RNA levels by microarray).

Quality of Life

Using patient-reported outcomes data, to determine the extent and severity of neuropathy associated with the addition of bortezomib to induction treatment.
Using patient-reported outcomes data, to determine the extent and severity of fatigue associated with the addition of lenalidomide to consolidation treatment.
To evaluate the effects of the addition of bortezomib and lenalidomide on patient-reported health-related quality of life.
To evaluate the effects of bortezomib-related neuropathy on patient-reported health-related quality of life.
To evaluate the response of lymphoma-specific symptoms to treatment.
Using longitudinal patient-reported outcomes data, to describe the trajectory of lymphoma symptoms, neuropathy, fatigue, and overall health-related quality of life prior to, during, and following treatment among older adults with MCL.

Imaging

To assess the proportion of patients up and down staging when fludeoxyglucose F 18- (FDG) PET/CT is added to standard Ann Arbor staging.
To assess the ability of pre-treatment FDG-PET/CT (SUVmax) to predict response rate and PFS.
Among patients with interim (post-cycle 3) FDG-PET/CT imaging, to assess the correlation of interim FDG-PET/CT imaging with response rate and PFS both during induction and consolidation therapy.
To assess standard FDG-PET/CT metrics including SUVmax, tumor metabolic burden, total tumor burden, and association with pathology features (blastoid variant vs other, and Ki67) in the setting of MCL.
To assess differences in overall and CR rates when using Deauville vs International Harmonization Project FDG-PET/CT interpretation criteria.
To determine whether there is a correlation between FDG-PET/CT response and residual disease assessment by molecular and/or flow cytometric techniques.

Residual Disease Assessment by Molecular and Flow Cytometric Techniques

To determine whether the number of malignant cells in circulation predict the number of cells in marrow.
To determine whether the number of malignant cells in circulation/in marrow at the end of induction correlate with CR and 2-year PFS.
To determine whether there is a higher rate of minimal residual disease (MRD) negativity among patients randomized to RBV as compared with RB, and among patients treated with LR maintenance compared with rituximab.
To compare the two methods of MRD detection - molecular techniques and flow cytometry - as prognostic markers for outcome.

OUTLINE: This is a multicenter study. Patients are stratified according to mantle cell lymphoma International Prognostic Index risk score (low vs intermediate vs high). Patients are randomized to 1 of 4 treatment arms.

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.
- 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.
Arm B: Patients receive induction therapy comprising bortezomib IV or 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.
- 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.
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.
- 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.
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.
- 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.

Patients may undergo blood and bone marrow sample collection at baseline and during treatment for correlative studies.

Patients complete the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym), the FACT/GOG-Neurotoxicity scale (FACT/GOG-Ntx), FACT-Fatigue, and FACT-General questionnaires at baseline and periodically during study and follow up.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 10 years.

Study Type

Interventional

Enrollment (Actual)

373

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 6Z8
    - The Moncton Hospital
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre
United States
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
- California
  - Antioch, California, United States, 94531
    - Kaiser Permanente-Deer Valley Medical Center
  - Fremont, California, United States, 94538
    - Kaiser Permanente, Fremont
  - Fresno, California, United States, 93720
    - Kaiser Permanente
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - Los Angeles County-USC Medical Center
  - Modesto, California, United States, 95356
    - Kaiser Permanente-Modesto
  - Oakland, California, United States, 94611
    - Kaiser Permanente-Oakland
  - Redwood City, California, United States, 94063
    - Kaiser Permanente-Redwood City
  - Richmond, California, United States, 94801
    - Kaiser Permanente-Richmond
  - Roseville, California, United States, 95661
    - Kaiser Permanente-Roseville
  - Sacramento, California, United States, 95823
    - Kaiser Permanente-South Sacramento
  - Sacramento, California, United States, 95825
    - Kaiser Permanente - Sacramento
  - San Francisco, California, United States, 94115
    - Kaiser Permanente-San Francisco
  - San Jose, California, United States, 95119
    - Kaiser Permanente-Santa Teresa-San Jose
  - San Leandro, California, United States, 94577
    - Kaiser Permanente San Leandro
  - San Rafael, California, United States, 94903
    - Kaiser Permanente-San Rafael
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center - Santa Clara
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente-Santa Rosa
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente-South San Francisco
  - Stanford, California, United States, 94305
    - Stanford University Hospitals and Clinics
  - Stockton, California, United States, 95210
    - Kaiser Permanente-Stockton
  - Vacaville, California, United States, 95688
    - Kaiser Permanente Medical Center-Vacaville
  - Vallejo, California, United States, 94589
    - Kaiser Permanente-Vallejo
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente-Walnut Creek
- Colorado
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers-Aurora
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Boulder, Colorado, United States, 80304
    - Rocky Mountain Cancer Centers-Boulder
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80205
    - Kaiser Permanente-Franklin
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Exempla Saint Joseph Hospital
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers-Midtown
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers-Rose
  - Denver, Colorado, United States, 80907
    - Colorado Blood Cancer Institute
  - Denver, Colorado, United States, 80224-2522
    - Colorado Cancer Research Program CCOP
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Durango, Colorado, United States, 81301
    - Southwest Oncology PC
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Englewood, Colorado, United States, 80113
    - Comprehensive Cancer Care and Research Institute of Colorado LLC
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Golden, Colorado, United States, 80401
    - Mountain Blue Cancer Care Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Greenwood Village, Colorado, United States, 80111
    - Rocky Mountain Cancer Centers-Greenwood Village
  - Lafayette, Colorado, United States, 80026
    - Kaiser Permanente-Rock Creek
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers-Littleton
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Kaiser Permanente-Lone Tree
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centers-Sky Ridge
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Parker, Colorado, United States, 80138
    - Rocky Mountain Cancer Centers-Parker
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers - Pueblo
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers-Thornton
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis Hospital and Medical Center
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19713
    - Medical Oncology Hematology Consultants PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
  - Newark, Delaware, United States, 19713
    - Christiana Gynecologic Oncology LLC
  - Newark, Delaware, United States, 19713
    - Regional Hematology and Oncology PA
  - Rehoboth Beach, Delaware, United States, 19971
    - Beebe Health Campus
  - Seaford, Delaware, United States, 19973
    - Nanticoke Memorial Hospital
  - Wilmington, Delaware, United States, 19801
    - Christiana Care Health System-Wilmington Hospital
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20057
    - Lombardi Comprehensive Cancer Center at Georgetown University
- Florida
  - Jacksonville, Florida, United States, 32207
    - Baptist Cancer Institute
  - Orlando, Florida, United States, 32806
    - UF Cancer Center at Orlando Health
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente Moanalua Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Oncare Hawaii Inc-POB II
  - Honolulu, Hawaii, United States, 96817-3169
    - OnCare Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96817
    - Oncare Hawaii Inc-Kuakini
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
  - ‘Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - ‘Aiea, Hawaii, United States, 96701
    - Oncare Hawaii Inc-Pali Momi
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Meridian, Idaho, United States, 83642
    - Idaho Urologic Institute-Meridian
  - Post Falls, Idaho, United States, 83854
    - Kootenai Cancer Center
  - Sandpoint, Idaho, United States, 83864
    - Kootenai Cancer
- Illinois
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60608
    - Mount Sinai Hospital Medical Center
  - Chicago, Illinois, United States, 60611
    - Hematology and Oncology Associates
  - Chicago, Illinois, United States, 60612-3785
    - John H Stroger Jr Hospital of Cook County
  - Danville, Illinois, United States, 61832
    - Carle on Vermilion
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Center of Decatur
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Highland Park, Illinois, United States, 60035
    - Hematology Oncology Associates of Illinois-Highland Park
  - Kankakee, Illinois, United States, 60901
    - Presence Saint Mary's Hospital
  - Libertyville, Illinois, United States, 60048
    - North Shore Hematology Oncology
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Niles, Illinois, United States, 60714
    - Illinois Cancer Specialists-Niles
  - Rockford, Illinois, United States, 61107
    - SwedishAmerican Regional Cancer Center/ACT
  - Skokie, Illinois, United States, 60076
    - Hematology Oncology Associates of Illinois - Skokie
  - Springfield, Illinois, United States, 62781-0001
    - Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
- Indiana
  - Lafayette, Indiana, United States, 47904
    - IU Health Arnett Cancer Care
  - Michigan City, Indiana, United States, 46360
    - Franciscan Saint Anthony Health-Michigan City
  - Michigan City, Indiana, United States, 46360
    - Woodland Cancer Care Center
  - Richmond, Indiana, United States, 47374
    - Reid Hospital and Health Care Services
- Iowa
  - Ames, Iowa, United States, 50010
    - Mary Greeley Medical Center
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC-William R Bliss Cancer Center
  - Bettendorf, Iowa, United States, 52722
    - Hematology Oncology Associates-Quad Cities
  - Boone, Iowa, United States, 50036
    - McFarland Clinic PC-Boone
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Association
  - Fort Dodge, Iowa, United States, 50501
    - McFarland Clinic PC-Trinity Cancer Center
  - Jefferson, Iowa, United States, 50129
    - McFarland Clinic PC-Jefferson
  - Marshalltown, Iowa, United States, 50158
    - McFarland Clinic PC-Marshalltown
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology Oncology Associates
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center-Sioux City
- Kansas
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's South Hospital
  - Prairie Village, Kansas, United States, 66208
    - Kansas City CCOP
  - Wichita, Kansas, United States, 67214
    - Wesley Medical Center
- Kentucky
  - Crestview Hills, Kentucky, United States, 41017
    - Oncology Hematology Care Inc-Crestview
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center-Summa
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Medical Center Jefferson
  - New Orleans, Louisiana, United States, 70115
    - Ochsner Baptist Medical Center
- Maine
  - Augusta, Maine, United States, 04330
    - Harold Alfond Center for Cancer Care
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
  - Rockport, Maine, United States, 04856
    - Penobscot Bay Medical Center
- Maryland
  - Baltimore, Maryland, United States, 21237
    - Franklin Square Hospital Center
  - Elkton, Maryland, United States, 21921
    - Union Hospital of Cecil County
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
  - Fitchburg, Massachusetts, United States, 01420
    - Simonds-Sinon Regional Cancer Center
  - Springfield, Massachusetts, United States, 01199
    - Baystate Medical Center
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Medical School
- Michigan
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium Community Clinical Oncology Program
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Big Rapids, Michigan, United States, 49307
    - Spectrum Health Big Rapids Hospital
  - Dearborn, Michigan, United States, 48124
    - Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48236
    - Saint John Hospital and Medical Center
  - Detroit, Michigan, United States, 48201
    - Wayne State University/Karmanos Cancer Institute
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology - Escanaba
  - Farmington Hills, Michigan, United States, 48334
    - Weisberg Cancer Treatment Center
  - Flint, Michigan, United States, 48502
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Blanc, Michigan, United States, 48439
    - Genesys Regional Medical Center
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Grand Rapids, Michigan, United States, 49503
    - Grand Rapids Clinical Oncology Program
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology - Iron Mountain
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Muskegon, Michigan, United States, 49444
    - Mercy Health Mercy Campus
  - Niles, Michigan, United States, 49120
    - Lakeland Community Hospital
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Saint Joseph Mercy Port Huron
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Saginaw, Michigan, United States, 48601
    - Saint Mary's of Michigan
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Hospital
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
- Minnesota
  - Bemidji, Minnesota, United States, 56601
    - Sanford Clinic North-Bemidgi
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro-Minnesota CCOP
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology and Hematology PA-Woodbury
- Missouri
  - Bonne Terre, Missouri, United States, 63628
    - Parkland Health Center-Bonne Terre
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Columbia, Missouri, United States, 65212
    - University of Missouri - Ellis Fischel
  - Independence, Missouri, United States, 64057
    - Centerpoint Medical Center LLC
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Medical Center-Goldschmidt Cancer Center
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital of Kansas City
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology and Oncology Associates Incorporated
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Liberty Radiation Oncology Center
  - Rolla, Missouri, United States, 65401
    - Phelps County Regional Medical Center
  - Rolla, Missouri, United States, 65401
    - Saint John's Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Springfield, Missouri, United States, 65804
    - Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - St Louis, Missouri, United States, 63141
    - Comprehensive Cancer Care PC
  - St Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - St Louis, Missouri, United States, 63141
    - Saint John's Mercy Medical Center
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - Missouri Baptist Outpatient Center-Sunset Hills
- Montana
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59101
    - Montana Cancer Consortium CCOP
  - Billings, Montana, United States, 59102
    - Frontier Cancer Center and Blood Institute-Billings
  - Billings, Montana, United States, 59107
    - Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare- Sletten Cancer Institute
  - Havre, Montana, United States, 59501
    - Northern Montana Hospital
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59801
    - Community Medical Hospital
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center
  - Nashua, New Hampshire, United States, 03063
    - Norris Cotton Cancer Center Nashua
- New Jersey
  - Camden, New Jersey, United States, 08103
    - Cooper Hospital University Medical Center
  - East Orange, New Jersey, United States, 07018-1095
    - Veterans Adminstration New Jersey Health Care System
- New York
  - Auburn, New York, United States, 13021
    - Hematology Oncology Associates of Central New York-Auburn
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York-East Syracuse
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
  - Liverpool, New York, United States, 13088
    - Hematology Oncology Associates of Central New York-Liverpool
  - Middletown, New York, United States, 10940
    - Orange Regional Medical Center
  - New York, New York, United States, 10065
    - Weill Medical College of Cornell University
  - New York, New York, United States, 10029
    - Mount Sinai Medical Center
  - Rochester, New York, United States, 14642
    - University of Rochester
  - Rome, New York, United States, 13440
    - Hematology Oncology Associates of Central New York-Rome
  - Syracuse, New York, United States, 13215
    - Hematology Oncology Associates of Central New York-Onondaga Hill
  - The Bronx, New York, United States, 10461
    - Albert Einstein College of Medicine
  - The Bronx, New York, United States, 10467-2490
    - Montefiore Medical Center - Moses Campus
- North Carolina
  - Clinton, North Carolina, United States, 28328
    - Southeastern Medical Oncology Center-Clinton
  - Goldsboro, North Carolina, United States, 27534
    - Southeastern Medical Oncology Center-Goldsboro
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Hendersonville, North Carolina, United States, 28739
    - Hendersonville Hematology and Oncology at Pardee
  - Hendersonville, North Carolina, United States, 28792
    - Park Ridge Hospital Breast Health Center
  - Jacksonville, North Carolina, United States, 28546
    - Southeastern Medical Oncology Center-Jacksonville
  - Kinston, North Carolina, United States, 28501
    - Kinston Medical Specialists PA
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
  - Wilson, North Carolina, United States, 27893
    - Southeastern Medical Oncology Center-Wilson
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- North Dakota
  - 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
    - Roger Maris Cancer Center
- Ohio
  - Akron, Ohio, United States, 44304
    - Summa Akron City Hospital/Cooper Cancer Center
  - Barberton, Ohio, United States, 44203
    - Summa Barberton Hospital
  - Beachwood, Ohio, United States, 44122
    - Cleveland Clinic Cancer Center Beachwood
  - Cincinnati, Ohio, United States, 45267
    - University of Cincinnati
  - Cincinnati, Ohio, United States, 45242
    - Oncology Hematology Care Inc-Blue Ash
  - Cincinnati, Ohio, United States, 45211
    - Oncology Hematology Care Inc-Mercy West
  - Cincinnati, Ohio, United States, 45230
    - Oncology Hematology Care Inc - Anderson
  - Cincinnati, Ohio, United States, 45219
    - Oncology and Hematology Care Inc-Taft
  - Cincinnati, Ohio, United States, 45236
    - Oncology Hematology Care Inc - Kenwood
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve University
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44111
    - Cleveland Clinic Cancer Center/Fairview Hospital
  - Columbus, Ohio, United States, 43210
    - Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Health Center
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45420
    - Dayton CCOP
  - Elyria, Ohio, United States, 44035
    - Mercy Cancer Center-Elyria
  - Fairfield, Ohio, United States, 45014
    - Oncology Hematology Care Inc-Healthplex
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Independence, Ohio, United States, 44131
    - Cleveland Clinic Cancer Center Independence
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Mansfield, Ohio, United States, 44906
    - Cleveland Clinic Cancer Center Mansfield
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
  - Mentor, Ohio, United States, 44060
    - Lake University Ireland Cancer Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Strongsville, Ohio, United States, 44136
    - Cleveland Clinic Cancer Center Strongsville
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Warrensville Heights, Ohio, United States, 44122
    - South Pointe Hospital
  - West Chester, Ohio, United States, 45069
    - University Pointe
  - Westlake, Ohio, United States, 44145
    - UH-Seidman Cancer Center at Saint John Medical Center
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic Wooster Specialty Center
  - Xenia, Ohio, United States, 45385
    - Greene Memorial Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Tulsa, Oklahoma, United States, 74146
    - Tulsa Cancer Institute
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Portland, Oregon, United States, 97213
    - Western Oncology Research Consortium
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - Lewisburg, Pennsylvania, United States, 17837
    - Geisinger Medical Oncology at Evangelical Community Hospital
  - Lewistown, Pennsylvania, United States, 17044
    - Lewistown Hospital
  - Philadelphia, Pennsylvania, United States, 19111
    - Fox Chase Cancer Center
  - Pottstown, Pennsylvania, United States, 19464
    - Pottstown Memorial Medical Center
  - Pottsville, Pennsylvania, United States, 17901
    - Geisinger Medical Oncology-Pottsville
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group
  - State College, Pennsylvania, United States, 16803
    - Mount Nittany Medical Center
  - West Reading, Pennsylvania, United States, 19611
    - Reading Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Health Cancer Center
  - Greenville, South Carolina, United States, 29601
    - Saint Francis Hospital
  - Greer, South Carolina, United States, 29651
    - Gibbs Cancer Center-Pelham
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Regional Medical Center
  - Spartanburg, South Carolina, United States, 29303
    - Upstate Carolina CCOP
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Wellmont Medical Associates Oncology and Hematology-Bristol
  - Bristol, Tennessee, United States, 37620
    - Wellmont Bristol Regional Medical Center
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Holston Valley Hospital and Medical Center
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Medical Associates Oncology and Hematology-Kingsport
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt-Ingram Cancer Center
- Texas
  - Dallas, Texas, United States, 75390
    - University of Texas Southwestern Medical Center
  - Dallas, Texas, United States, 75235
    - Parkland Memorial Hospital
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
  - Martinsville, Virginia, United States, 24115
    - Memorial Hospital Of Martinsville
  - Norton, Virginia, United States, 24273
    - Southwest VA Regional Cancer Center
  - Richmond, Virginia, United States, 23298-0037
    - Massey Cancer Center at Virginia Commonwealth University
- Washington
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Kirkland, Washington, United States, 98034
    - Seattle Cancer Care Alliance at EvergreenHealth
  - Kirkland, Washington, United States, 98033
    - EvergreenHealth Medical Center
  - Longview, Washington, United States, 98632
    - Saint John Medical Center
  - Mount Vernon, Washington, United States, 98273
    - Skagit Valley Hospital Regional Cancer Care Center
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital
  - Port Angeles, Washington, United States, 98362
    - Olympic Medical Center
  - Seattle, Washington, United States, 98109
    - Seattle Cancer Care Alliance
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  - Sequim, Washington, United States, 98384
    - Olympic Medical Cancer Care Center
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, United States, 99216
    - Cancer Care Northwest-Valley
  - Spokane, Washington, United States, 99218
    - Cancer Care Northwest-North Spokane
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Vancouver, Washington, United States, 98684
    - Compass Oncology Vancouver
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospital and Clinics
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - West Virginia University Healthcare
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Langlade Hospital and Cancer Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Center at Sacred Heart
  - Eau Claire, Wisconsin, United States, 54701
    - Sacred Heart Hospital
  - Fond du Lac, Wisconsin, United States, 54935
    - Agnesian Cancer Center
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - Johnson Creek, Wisconsin, United States, 53038
    - UW Cancer Center Johnson Creek
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Hospital and Clinics
  - Manitowoc, Wisconsin, United States, 54221
    - Holy Family Memorial Hospital
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic
  - Marshfield, Wisconsin, United States, 54449
    - Saint Joseph's Hospital
  - Milwaukee, Wisconsin, United States, 53226
    - Froedtert and the Medical College of Wisconsin
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - Mukwonago, Wisconsin, United States, 53149
    - D N Greenwald Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Oconomowoc, Wisconsin, United States, 53066-3896
    - Oconomowoc Memorial Hospital-ProHealth Care Inc
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology - Oconto Falls
  - Rhinelander, Wisconsin, United States, 54501
    - Saint Mary's Hospital
  - Rhinelander, Wisconsin, United States, 54501
    - Marshfield Clinic at James Beck Cancer Center
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic-Rice Lake Center
  - Sheboygan, Wisconsin, United States, 53081
    - Saint Nicholas Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Saint Michael's Hospital
  - Stevens Point, Wisconsin, United States, 54481
    - Marshfield Clinic Cancer Care at Saint Michael's Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology - Sturgeon Bay
  - Waukesha, Wisconsin, United States, 53188
    - Waukesha Memorial Hospital - ProHealth Care
  - Wausau, Wisconsin, United States, 54401
    - Aspirus Regional Cancer Center
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic-Wausau Center
  - Weston, Wisconsin, United States, 54476
    - Diagnostic and Treatment Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Weston, Wisconsin, United States, 54476
    - Saint Clare's Hospital
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Cody, Wyoming, United States, 82414
    - Big Horn Basin Cancer Center
  - Cody, Wyoming, United States, 82414
    - Billings Clinic-Cody
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Step 1 (Induction) Inclusion Criteria:

Mantle Cell Lymphoma International Prognostic Index (MIPI) score must be calculated and entered in OPEN
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
Negative pregnancy test
Women of childbearing potential and sexually active males use an accepted and effective method of contraception
ECOG performance status 0-2
Absolute neutrophil count (ANC) ≥ 1,500/mcL (1.5 x 10^9/L)
Platelets ≥ 100,000/mcL (100 x 10^9/L)
Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2 times upper limit of normal (ULN)
Bilirubin ≤ 2 times ULN
Calculated creatinine clearance by Cockroft-Gault formula ≥ 30 mL/min
Patient agrees that if randomized to Arms C or D, and proceeding 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, DVT prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis. Patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have full anticoagulation, therapeutic doses of low molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0, or any other accepted full anticoagulation regimen (e.g. direct thrombin inhibitors or Factor Xa inhibitors) with appropriate monitoring for that agent. 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 or another accepted full anticoagulation regimen. Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing prothrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g. uninterrupted long car or plane trips).
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
- CD4 count at screening >= 300 cells/mm³
- 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

Step 1 (Induction) Exclusion Criteria:

Women (sexually mature female) must not be pregnant or breast-feeding
Evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, low grade prostate carcinoma (Gleason grade ≤ 6) managed with observation that has been stable for at least 6 months, or any malignancy treated with curative intent continuously disease free for >=3 years so as not to interfere with interpretation of radiographic response
Prior therapy for MCL, except: < 2 weeks of steroid therapy for symptom control or local radiation therapy for symptom control if there is measurable disease outside the radiation portal. Patients may be on chronic steroids for non-malignant disease if on a stable dose equivalent to ≤ 20 mg prednisone per day.
CNS involvement
History of AIDS-defining conditions
Grade 2 or greater peripheral neuropathy.
NYHA Class III or IV heart failure, uncontrolled angina severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
Hypersensitivity to bortezomib, boron or mannitol
A serious medical or psychiatric illness likely to interfere with study participation
Participating in any other therapeutic clinical trial or taking any other experimental medications within 14 days prior to registration.

Step 2 (Maintenance) Inclusion Criteria:

ECOG performance status between 0-2
Complete response, partial response or stable disease after Step 1
ANC >= 1000 cells/mm3 (1.0 x 10^9/L)
Platelets >= 75,000 cells/mm3 (75 x 10^9/L)
AST/ALT <= 2 x upper limit of normal (ULN)
Total bilirubin <= 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin <= 2 x upper limit of normal (ULN)
Calculated creatinine clearance by Cockroft-Gault formula >= 30 ml/min
Patient agrees that if randomized to Arms C or D, and proceeding onto Arms G or H, they must register into the mandatory REMS program, and be willing and able to comply with the requirements of REMS.
- Pregnancy tests must occur within 10 - 14 days and again within 24 hours prior to initiation of Cycle 1 of lenalidomide.
- Females of childbearing potential (FCBP)* with regular or no menstruation must have a pregnancy test weekly for the first 28 days and then every 28 days while on lenalidomide therapy (including breaks in therapy); at discontinuation of lenalidomide and at Day 28 post the last dose of lenalidomide. Females with irregular menstruation must have a pregnancy test weekly for the first 28 days and then every 14 days while on lenalidomide therapy (including breaks in therapy), at discontinuation of lenalidomide and at Day 14 and Day 28 post the last dose of lenalidomide (see Appendix VI: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods).
- Females of childbearing potential (FCBP)* must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP 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.
- A female of childbearing potential is any sexually mature female, regardless of sexual orientation of whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study/lenaliomide: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study including interruptions in therapy; and 3) for at least 28 days after discontinuation/stopping lenalidomide. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
- 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. All males, regardless of whether they have undergone a successful vasectomy, must agree to use a latex condom during sexual contact with a female of childbearing potential, or to practice complete abstinence from heterosexual intercourse with any female of childbearing potential during all cycles of study treatment and for at least 28 days following discontinuation of protocol treatment
- Patients must have no medical contra-indications to, and be willing to take, DVT prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis. Patients randomized to Arms G or H who have full anticoagulation, 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, or any other accepted full anticoagulation regimen (e.g. direct thrombin inhibitors or Factor Xa inhibitors) with appropriate monitoring for that agent. 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 or another accepted full anticoagulation regimen. Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing pro-thrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g. uninterrupted long car or plane trips).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Induction: (A) Bendamustine + Rituximab then Maintenance: (E) Rituximab 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 maintenance treatment. Patients receive maintenance 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 Other Names: Rituxan IDEC-C2B8 Chimeric anti-CD20 monoclonal antibody Drug: Bendamustine Given IV Other Names: CEP-18083 bendamustine hydrochloride TREANDA BENDEKA
Experimental: Induction: (B) Bendamustine + Rituximab + Bortezomib then Maintenance: (F) Rituximab Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance 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 Other Names: Rituxan IDEC-C2B8 Chimeric anti-CD20 monoclonal antibody Drug: Bendamustine Given IV Other Names: CEP-18083 bendamustine hydrochloride TREANDA BENDEKA Drug: bortezomib Given IV or SC Other Names: MLN341 LDP-341 Velcade®
Experimental: Induction: (C) Bendamustine + Rituximab then Maintenance: (G) Lenalidomide + Rituximab 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 maintenance treatment. Patients then proceed to maintenance treatment. Patients receive maintenance 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.	Drug: lenalidomide Given PO Other Names: Revlimid® IMiDTM compound CC-5013 Biological: rituximab Given IV Other Names: Rituxan IDEC-C2B8 Chimeric anti-CD20 monoclonal antibody Drug: Bendamustine Given IV Other Names: CEP-18083 bendamustine hydrochloride TREANDA BENDEKA
Experimental: Induction: (D) Bendamustine + Rituximab + Bortezomib then Maintenance: (H) Lenalidomide + Rituximab Patients receive induction therapy comprising rituximab IV on day 1, bendamustine hydrochloride IV over 60 minutes on days 1-2 and bortezomib IV subcutaneously (SC) on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then proceed to maintenance treatment. Patients receive maintenance 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.	Drug: lenalidomide Given PO Other Names: Revlimid® IMiDTM compound CC-5013 Biological: rituximab Given IV Other Names: Rituxan IDEC-C2B8 Chimeric anti-CD20 monoclonal antibody Drug: Bendamustine Given IV Other Names: CEP-18083 bendamustine hydrochloride TREANDA BENDEKA Drug: bortezomib Given IV or SC Other Names: MLN341 LDP-341 Velcade®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) for Induction Phase Time Frame: Assessed at baseline, every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months	PFS is defined as time from randomization to lymphoma progression or death. Progression is defined as: Appearance of any new lesion >1.5 cm in any axis during or at the end of therapy >=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. >=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems	Assessed at baseline, every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months
Progression-free Survival (PFS) for Maintenance Phase (Step 2) Time Frame: Assessed at registration to step 2, cycles 6, 12, 18, treatment completion, then every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months	PFS is defined as time from Step 2 registration to lymphoma progression or death. Progression is defined as: Appearance of any new lesion >1.5 cm in any axis during or at the end of therapy >=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions. >=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis. Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems	Assessed at registration to step 2, cycles 6, 12, 18, treatment completion, then every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response for Induction Phase (Step 1) Time Frame: Assessed at baseline and 24 weeks (end of cycle 6)	Objective response is defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. PR is defined as: ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses No increase in the size of other nodes, liver or spleen. Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified, e.g. large-cell lymphoma or small cleaved cell lymphoma. No new sites of disease. Patients who achieve a CR but have persistent morphologic bone marrow involvement will be considered partial responders. When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients are considered partial responders.	Assessed at baseline and 24 weeks (end of cycle 6)
PET-documented Complete Response for Induction Phase (Step 1) Time Frame: Assessed at baseline and 24 weeks (end of cycle 6)	Complete response is defined as disappearance of all detectable clinical evidence of disease.	Assessed at baseline and 24 weeks (end of cycle 6)
Overall Survival (OS) Rate at 5 Years Since Maintenance (Step 2) Time Frame: Assessed every 3 months for 2.5 years, every 6 months for years 2.5-5	OS is defined as the time from registration of Step 2 (maintenance) until death from any cause or last know alive. The Kaplan-Meier estimate of 5-year OS rate is reported.	Assessed every 3 months for 2.5 years, every 6 months for years 2.5-5
Objective Response for Maintenance (Step 2) Among Patients Without PET-documented CR at the End of Induction Time Frame: Assessed at baseline and every 4 months for 2 years	Objective response is defined as either complete response (CR) or partial response (PR). CR is defined as disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy. PR is defined as: ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses No increase in the size of other nodes, liver or spleen. Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified, e.g. large-cell lymphoma or small cleaved cell lymphoma. No new sites of disease. Patients who achieve a CR but have persistent morphologic bone marrow involvement will be considered partial responders. When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients are considered partial responders.	Assessed at baseline and every 4 months for 2 years

Other Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Mitchell R. Smith, MD, PhD, Fox Chase Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Smith MR, Jegede OA, Martin P, Till BG, Parekh SS, Yang DT, Hsi ED, Witzig T, Dave S, Scott D, Hanson C, Kostakoglu Shields L, Abdel-Samad N, Casulo C, Bartlett NL, Caimi PF, Al Baghdadi T, Blum KA, Romer MD, Inwards DJ, Lerner RE, Wagner LI, Little RF, Friedberg JW, Leonard JP, Kahl BS. Randomized study of induction with bendamustine-rituximab +/- bortezomib and maintenance with rituximab +/- lenalidomide for MCL. Blood. 2024 Sep 5;144(10):1083-1092. doi: 10.1182/blood.2024023962.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2012

Primary Completion (Actual)

February 25, 2023

Study Completion (Estimated)

September 1, 2031

Study Registration Dates

First Submitted

August 11, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (Estimated)

August 12, 2011

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

E1411
NCI-2011-02980 (Other Identifier: NCI)
CDR0000707057 (Other Identifier: NCI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Outcome Measure	Measure Description	Time Frame
To Collect Paraffin Embedded Tissue for Creation of Tissue Microarray Time Frame: Assessed at baseline	Collection of paraffin embedded tissue for creation of tissue microarray	Assessed at baseline
To Collect and Bank Serum and Blood Mononuclear Cells for Future Studies Time Frame: Assessed at baseline, end of cycle 3, end of cycle 6, every 4 months during first year of maintenance, every 6 months during 2nd year of maintenance, and 12 months after completion of maintenance	Collecting and banking serum and blood mononuclear cells for future studies	Assessed at baseline, end of cycle 3, end of cycle 6, every 4 months during first year of maintenance, every 6 months during 2nd year of maintenance, and 12 months after completion of maintenance
To Collect Formalin Fixed Paraffin Embedded (FFPE) Tissue to Analyze Potential Prognostic Factors Time Frame: Assessed at baseline	Collection of formalin fixed paraffin embedded (FFPE) tissue for future analysis of potential prognostic factors	Assessed at baseline
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity (FACT/GOG-Ntx Subscale) Score Time Frame: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months	FACT/GOG-Ntx subscale has 11 items and the score ranges from 0 to 44. The higher the score, the better the quality of life.	Assessed at baseline, 6, 12, 30, 36, 48 and 60 months
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Scale Score Time Frame: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months	FACIT-Fatigue scale has 14 items and the score ranges from 0 to 56. The higher the score, the better the quality of life.	Assessed at baseline, 6, 12, 30, 36, 48 and 60 months
Functional Assessment of Cancer Therapy - General (FACT-G) Score Time Frame: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months	FACT-G subscale has 27 items and the score ranges from 0 to 108. The higher the score, the better the quality of life.	Assessed at baseline, 6, 12, 30, 36, 48 and 60 months
To Evaluate the Effects of Bortezomib-related Neuropathy (FACT/GOG-Ntx Subscale Score) on Patient Reported Health-related Quality of Life (FACT-G Score). Time Frame: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months	FACT/GOG-Ntx subscale has 11 items and the score ranges from 0 to 44. FACT-G has 27 items and the score ranges from 0 to 108. The higher the score, the better the quality of life for both scales.	Assessed at baseline, 6, 12, 30, 36, 48 and 60 months
Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lymphoma) Subscale Score Time Frame: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months	FACT-Lymphoma has 15 items and the score ranges from 0 to 60. The higher the score, the better the quality of life.	Assessed at baseline, 6, 12, 30, 36, 48 and 60 months
To Evaluate the Response of Lymphoma-specific Symptoms to Treatment. Time Frame: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months	FACT-Lymphoma has 15 items and the score ranges from 0 to 60. The higher the score, the better the quality of life.	Assessed at baseline, 6, 12, 30, 36, 48 and 60 months
The Trajectory of Overall Health-related Quality of Life Time Frame: Assessed at baseline, 6, 12, 30, 36, 48 and 60 months	The overall health-related quality of life is evaluated using FACT-G. FACT-G subscale has 27 items and the score ranges from 0 to 108. The higher the score, the better the quality of life.	Assessed at baseline, 6, 12, 30, 36, 48 and 60 months
To Assess the Proportion of Patients up and Down Staging When FDGPET/CT is Added to Standard Ann Arbor Staging. Time Frame: Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years	Assessment of the proportion of patients up and down staging when FDGPET/CT is added to standard Ann Arbor staging will be performed.	Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years
To Assess the Ability of Pre-treatment FDG-PET/CT Semi Quantitative Parameters Including SUVmax and Metabolic Measurements to Predict Response Rate and PFS. Time Frame: Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years	To assess the ability of pre-treatment FDG-PET/CT semi quantitative parameters including SUVmax and metabolic measurements to predict response rate and PFS.	Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years
Assessment of the Correlation of Interim FDG-PET/CT Imaging With Response Rate and PFS Both During Induction and Consolidation Therapy Time Frame: Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years	Among patients with interim FDG-PET/CT imaging, to assess the correlation of interim FDG-PET/CT imaging with response rate and PFS both during induction and consolidation therapy.	Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years
To Assess Standard FDG-PET/CT Metrics and Association With Pathology Features Time Frame: Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years	To assess standard FDG-PET/CT metrics including SUVmax, tumor metabolic burden, total tumor burden, and association with pathology features (blastoid variant vs. other, and Ki67) in the setting of MCL.	Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years
Difference in Overall Response Rates Between Deauville and International Harmonization Project FDG-PET/CT Interpretation Criteria Time Frame: Assessed at baseline and every 4 months for 2 years	To assess differences in overall and complete response rates when using Deauville vs. International Harmonization Project FDG-PET/CT interpretation criteria.	Assessed at baseline and every 4 months for 2 years
Correlation Between FDG-PET/CT Response and Residual Disease Time Frame: Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years	To determine whether there is a correlation between FDG-PET/CT response and residual disease assessment by molecular and/or flow cytometric techniques	Assessed at baseline and every 4 months for 2 years and every 6 months for years 3-10 and then annually up to 15 years
To Determine Whether the Number of Malignant Cells in Circulation Predict the Number of Cells in Marrow Time Frame: Assessed at baseline and end of cycle 6	To determine whether the number of malignant cells in circulation predict the number of cells in marrow	Assessed at baseline and end of cycle 6
The Association Between the Number of Malignant Cells in Circulation or Marrow at the End of Induction and Clinical Outcomes Time Frame: Assessed at baseline and every 4 months for 2 years	To determine whether the number of malignant cells in circulation/in marrow at the end of induction correlate with CR and 2 year PFS	Assessed at baseline and every 4 months for 2 years
Proportion of Patients With Minimal Residual Disease (MRD) Time Frame: Assessed at baseline, end of cycles 3 and 6, every 4 months during 1st year of maintenance, every 6 months during 2nd year of maintenance and 12 months after completion of maintenance	Minimal residual disease (MRD) will be evaluated using blood samples and bone marrow samples collected on this study.	Assessed at baseline, end of cycles 3 and 6, every 4 months during 1st year of maintenance, every 6 months during 2nd year of maintenance and 12 months after completion of maintenance
Difference in MRD Levels by Molecular Techniques and Flow Cytometry Time Frame: Assessed at baseline, end of cycles 3 and 6, every 4 months during 1st year of maintenance, every 6 months during 2nd year of maintenance and 12 months after completion of maintenance	MRD levels will be evaluated using two different methods, molecular techniques and flow cytometry. The difference in MRD levels between the two methods will be assessed.	Assessed at baseline, end of cycles 3 and 6, every 4 months during 1st year of maintenance, every 6 months during 2nd year of maintenance and 12 months after completion of maintenance

Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Lymphoma

Clinical Trials on lenalidomide

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