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Rituximab og kombinasjonskjemoterapi med eller uten lenalidomid ved behandling av pasienter med nylig diagnostisert stadium II-IV diffust storcellet B-celle lymfom

24. oktober 2026 oppdatert av: National Cancer Institute (NCI)

Randomisert fase II åpen undersøkelse av lenalidomid R-CHOP (R2CHOP) vs. RCHOP (rituximab, cyklofosfamid, doksorubicin, vinkristin og prednison) hos pasienter med nylig diagnostisert diffust storcellet B-celle lymfom

This randomized phase II trial studies how well rituximab and combination chemotherapy with or without lenalidomide work in treating patients with newly diagnosed stage II-IV diffuse large B cell lymphoma. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether rituximab and combination chemotherapy are more effective when given with or without lenalidomide in treating patients with diffuse large B cell lymphoma.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

PRIMARY OBJECTIVES:

I. Progression-free survival (PFS).

SECONDARY OBJECTIVES:

I. Response rate (RR). II. Complete remission (CR) rate as defined by positron emission tomography (PET)-computed tomography (CT) criteria.

III. Overall survival (OS).

TERTIARY OBJECTIVES:

I. Impact of diffuse large B cell lymphoma (DLBCL) molecular subtype on outcome.

II. Interim PET scan results in relation to treatment outcome.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive rituximab intravenously (IV), cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone orally (PO) on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then annually for up to 7 years.

Studietype

Intervensjonell

Registrering (Faktiske)

349

Fase

  • Fase 2

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    • Minnesota
      • Bemidji, Minnesota, Forente stater, 56601
        • Sanford Joe Lueken Cancer Center
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        • Fairview Ridges Hospital
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        • Mercy Hospital
      • Duluth, Minnesota, Forente stater, 55805
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      • Duluth, Minnesota, Forente stater, 55805
        • Essentia Health Cancer Center
      • Edina, Minnesota, Forente stater, 55435
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, Forente stater, 56537
        • Lake Region Healthcare Corporation-Cancer Care
      • Fridley, Minnesota, Forente stater, 55432
        • Unity Hospital
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      • Maplewood, Minnesota, Forente stater, 55109
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        • Hennepin County Medical Center
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        • North Memorial Medical Health Center
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        • Park Nicollet Clinic - Saint Louis Park
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        • Regions Hospital
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      • Jackson, Mississippi, Forente stater, 39216
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      • Bolivar, Missouri, Forente stater, 65613
        • Central Care Cancer Center - Bolivar
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Forente stater, 63703
        • Mercy Cancer Center - Cape Girardeau
      • Chesterfield, Missouri, Forente stater, 63017
        • Saint Luke's Hospital
      • Jefferson City, Missouri, Forente stater, 65109
        • MU Health Care Goldschmidt Cancer Center
      • Kansas City, Missouri, Forente stater, 64111
        • Saint Luke's Hospital of Kansas City
      • Rolla, Missouri, Forente stater, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Forente stater, 65401
        • Phelps Health Delbert Day Cancer Institute
      • Springfield, Missouri, Forente stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forente stater, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, Forente stater, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, Forente stater, 63109
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Forente stater, 63141
        • Mercy Hospital Saint Louis
    • Montana
      • Billings, Montana, Forente stater, 59101
        • Billings Clinic Cancer Center
      • Bozeman, Montana, Forente stater, 59715
        • Bozeman Health Deaconess Hospital
      • Butte, Montana, Forente stater, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Forente stater, 59405
        • Benefis Sletten Cancer Institute
      • Kalispell, Montana, Forente stater, 59901
        • Logan Health Medical Center
      • Missoula, Montana, Forente stater, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Forente stater, 59804
        • Community Medical Center
    • Nebraska
      • Grand Island, Nebraska, Forente stater, 68803
        • Nebraska Cancer Specialists/Oncology Hematology West PC
      • Kearney, Nebraska, Forente stater, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, Forente stater, 68506
        • Nebraska Hematology and Oncology
      • Lincoln, Nebraska, Forente stater, 68510
        • Nebraska Cancer Research Center
      • Lincoln, Nebraska, Forente stater, 68516
        • Cancer Partners of Nebraska
      • Omaha, Nebraska, Forente stater, 68198
        • University of Nebraska Medical Center
    • Nevada
      • Henderson, Nevada, Forente stater, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Forente stater, 89052
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Forente stater, 89052
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Forente stater, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Forente stater, 89074
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, Forente stater, 89106
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Forente stater, 89119
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Forente stater, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Forente stater, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Forente stater, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forente stater, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Forente stater, 89102
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • Cancer and Blood Specialists-Shadow
      • Las Vegas, Nevada, Forente stater, 89109
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Forente stater, 89113
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Forente stater, 89121
        • Cancer Therapy and Integrative Medicine
      • Las Vegas, Nevada, Forente stater, 89128
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Forente stater, 89148-2405
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Forente stater, 89149
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Forente stater, 89120
        • Nevada Cancer Research Foundation NCORP
      • Las Vegas, Nevada, Forente stater, 89128
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, Forente stater, 89183
        • OptumCare Cancer Care at Fort Apache
    • New Hampshire
      • Concord, New Hampshire, Forente stater, 03301
        • New Hampshire Oncology Hematology PA-Concord
      • Dover, New Hampshire, Forente stater, 03820
        • Wentworth-Douglass Hospital
      • Laconia, New Hampshire, Forente stater, 03246
        • LRGHealthcare-Lakes Region General Hospital
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
      • Manchester, New Hampshire, Forente stater, 03103
        • Solinsky Center for Cancer Care
    • New Jersey
      • Camden, New Jersey, Forente stater, 08103
        • Cooper Hospital University Medical Center
      • Englewood, New Jersey, Forente stater, 07631
        • Englewood Hospital and Medical Center
      • Livingston, New Jersey, Forente stater, 07039
        • Cooperman Barnabas Medical Center
      • Mount Holly, New Jersey, Forente stater, 08060
        • Virtua Memorial
      • Mullica Hill, New Jersey, Forente stater, 08062
        • Inspira Medical Center Mullica Hill
      • Paramus, New Jersey, Forente stater, 07652
        • The Valley Hospital - Luckow Pavilion
      • Ridgewood, New Jersey, Forente stater, 07450
        • Valley Health System Ridgewood Campus
      • Vineland, New Jersey, Forente stater, 08360
        • Inspira Medical Center Vineland
      • Westwood, New Jersey, Forente stater, 07675
        • Valley Health System-Hematology/Oncology
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87106
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, Forente stater, 87110
        • Presbyterian Kaseman Hospital
      • Las Cruces, New Mexico, Forente stater, 88011
        • Memorial Medical Center-Las Cruces
      • Santa Fe, New Mexico, Forente stater, 87505
        • Christus Saint Vincent Regional Cancer Center
    • New York
      • Brooklyn, New York, Forente stater, 11203
        • Kings County Hospital
      • Brooklyn, New York, Forente stater, 11203
        • State University of New York Downstate Medical Center
      • Buffalo, New York, Forente stater, 14263
        • Roswell Park Cancer Institute
      • East Syracuse, New York, Forente stater, 13057
        • Hematology Oncology Associates of Central New York-East Syracuse
      • New York, New York, Forente stater, 10032
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
      • New York, New York, Forente stater, 10016
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
      • Plattsburgh, New York, Forente stater, 12901
        • Champlain Valley Physicians Hospital Medical Center
      • Rochester, New York, Forente stater, 14642
        • University of Rochester
      • Syracuse, New York, Forente stater, 13210
        • State University of New York Upstate Medical University
      • The Bronx, New York, Forente stater, 10461
        • Montefiore Medical Center-Einstein Campus
      • The Bronx, New York, Forente stater, 10467
        • Montefiore Medical Center - Moses Campus
      • The Bronx, New York, Forente stater, 10461
        • Montefiore Medical Center-Weiler Hospital
    • North Carolina
      • Asheboro, North Carolina, Forente stater, 27203
        • Randolph Hospital
      • Chapel Hill, North Carolina, Forente stater, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Clinton, North Carolina, Forente stater, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Goldsboro, North Carolina, Forente stater, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Goldsboro, North Carolina, Forente stater, 27534
        • Wayne Memorial Hospital
      • Greensboro, North Carolina, Forente stater, 27403
        • Cone Health Cancer Center
      • Hendersonville, North Carolina, Forente stater, 28791
        • Margaret R Pardee Memorial Hospital
      • Jacksonville, North Carolina, Forente stater, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • Kinston, North Carolina, Forente stater, 28501
        • ECU Health Oncology Kinston
      • Reidsville, North Carolina, Forente stater, 27320
        • Annie Penn Memorial Hospital
      • Statesville, North Carolina, Forente stater, 28677
        • Iredell Memorial Hospital
      • Washington, North Carolina, Forente stater, 27889
        • Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
      • Winston-Salem, North Carolina, Forente stater, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, Forente stater, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Forente stater, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, Forente stater, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, Forente stater, 44307
        • Cleveland Clinic Akron General
      • Akron, Ohio, Forente stater, 44304
        • Summa Health System - Akron Campus
      • Barberton, Ohio, Forente stater, 44203
        • Summa Health System - Barberton Campus
      • Canton, Ohio, Forente stater, 44708
        • Cleveland Clinic Mercy Hospital
      • Chardon, Ohio, Forente stater, 44024
        • Geauga Hospital
      • Cincinnati, Ohio, Forente stater, 45219
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cincinnati, Ohio, Forente stater, 45220
        • Good Samaritan Hospital - Cincinnati
      • Cincinnati, Ohio, Forente stater, 45247
        • TriHealth Cancer Institute-Westside
      • Cincinnati, Ohio, Forente stater, 45255
        • TriHealth Cancer Institute-Anderson
      • Cleveland, Ohio, Forente stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forente stater, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, Forente stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, Forente stater, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Forente stater, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, Forente stater, 43222
        • Mount Carmel Health Center West
      • Columbus, Ohio, Forente stater, 43215
        • Columbus NCI Community Oncology Research Program
      • Dayton, Ohio, Forente stater, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, Forente stater, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, Forente stater, 45415
        • Miami Valley Hospital North
      • Elyria, Ohio, Forente stater, 44035
        • Mercy Cancer Center-Elyria
      • Findlay, Ohio, Forente stater, 45840
        • Blanchard Valley Hospital
      • Lima, Ohio, Forente stater, 45801
        • Saint Rita's Medical Center
      • Marietta, Ohio, Forente stater, 45750
        • Marietta Memorial Hospital
      • Maumee, Ohio, Forente stater, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Mayfield Heights, Ohio, Forente stater, 44124
        • UH Seidman Cancer Center at Landerbrook Health Center
      • Mentor, Ohio, Forente stater, 44060
        • UH Seidman Cancer Center at Lake Health Mentor Campus
      • Newark, Ohio, Forente stater, 43055
        • Licking Memorial Hospital
      • Sandusky, Ohio, Forente stater, 44870
        • UH Seidman Cancer Center at Firelands Regional Medical Center
      • Springfield, Ohio, Forente stater, 45504
        • Springfield Regional Cancer Center
      • Springfield, Ohio, Forente stater, 45504
        • Springfield Regional Medical Center
      • Sylvania, Ohio, Forente stater, 43560
        • ProMedica Flower Hospital
      • Toledo, Ohio, Forente stater, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, Forente stater, 43614
        • University of Toledo
      • Westerville, Ohio, Forente stater, 43081
        • Saint Ann's Hospital
      • Westlake, Ohio, Forente stater, 44145
        • UH Seidman Cancer Center at Saint John Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Forente stater, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Clackamas, Oregon, Forente stater, 97015
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Forente stater, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Forente stater, 97420
        • Bay Area Hospital
      • Newberg, Oregon, Forente stater, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, Forente stater, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, Forente stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forente stater, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Forente stater, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Bryn Mawr, Pennsylvania, Forente stater, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, Forente stater, 17822
        • Geisinger Medical Center
      • Doylestown, Pennsylvania, Forente stater, 18901
        • Doylestown Hospital
      • Drexel Hill, Pennsylvania, Forente stater, 19026
        • Delaware County Memorial Hospital
      • Ephrata, Pennsylvania, Forente stater, 17522
        • Ephrata Cancer Center
      • Ephrata, Pennsylvania, Forente stater, 17522
        • Ephrata Community Hospital
      • Gettysburg, Pennsylvania, Forente stater, 17325
        • Adams Cancer Center
      • Hanover, Pennsylvania, Forente stater, 17331
        • WellSpan Medical Oncology and Hematology
      • Hazleton, Pennsylvania, Forente stater, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Hershey, Pennsylvania, Forente stater, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Lewisburg, Pennsylvania, Forente stater, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Paoli, Pennsylvania, Forente stater, 19301
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, Forente stater, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Forente stater, 19140
        • Temple University Hospital
      • Pottstown, Pennsylvania, Forente stater, 19464
        • Pottstown Hospital
      • Pottsville, Pennsylvania, Forente stater, 17901
        • Geisinger Cancer Services-Pottsville
      • Scranton, Pennsylvania, Forente stater, 18508
        • Hematology and Oncology Associates of North East Pennsylvania
      • Selinsgrove, Pennsylvania, Forente stater, 17870
        • Geisinger Medical Oncology-Selinsgrove
      • Sellersville, Pennsylvania, Forente stater, 18960
        • Grand View Hospital
      • State College, Pennsylvania, Forente stater, 16803
        • Mount Nittany Medical Center
      • West Chester, Pennsylvania, Forente stater, 19380
        • Chester County Hospital
      • West Reading, Pennsylvania, Forente stater, 19611
        • Reading Hospital
      • Wilkes-Barre, Pennsylvania, Forente stater, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • Wynnewood, Pennsylvania, Forente stater, 19096
        • Lankenau Medical Center
      • York, Pennsylvania, Forente stater, 17403
        • WellSpan Health-York Hospital
    • South Carolina
      • Boiling Springs, South Carolina, Forente stater, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Easley, South Carolina, Forente stater, 29640
        • Prisma Health Cancer Institute - Easley
      • Greenville, South Carolina, Forente stater, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Forente stater, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, Forente stater, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, Forente stater, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greenville, South Carolina, Forente stater, 29601
        • Greenville Health System Cancer Institute-Andrews
      • Greer, South Carolina, Forente stater, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, Forente stater, 29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Rapid City, South Dakota, Forente stater, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Forente stater, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Forente stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Forente stater, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37232
        • Vanderbilt University/Ingram Cancer Center
    • Texas
      • Austin, Texas, Forente stater, 78701
        • Dell Seton Medical Center at The University of Texas
      • Dallas, Texas, Forente stater, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, Forente stater, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Fort Sam Houston, Texas, Forente stater, 78234
        • Brooke Army Medical Center
      • Lubbock, Texas, Forente stater, 79410
        • Covenant Medical Center-Lakeside
      • Lubbock, Texas, Forente stater, 79430
        • Texas Tech University Health Sciences Center-Lubbock
      • San Antonio, Texas, Forente stater, 78229
        • University of Texas Health Science Center at San Antonio
    • Utah
      • Salt Lake City, Utah, Forente stater, 84112
        • Huntsman Cancer Institute/University of Utah
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • University of Virginia Cancer Center
      • Fishersville, Virginia, Forente stater, 22939
        • Augusta Health Center for Cancer and Blood Disorders
      • Martinsville, Virginia, Forente stater, 24112
        • Sovah Health Martinsville
    • Washington
      • Edmonds, Washington, Forente stater, 98026
        • Swedish Cancer Institute-Edmonds
      • Longview, Washington, Forente stater, 98632
        • PeaceHealth Saint John Medical Center
      • Seattle, Washington, Forente stater, 98107
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Forente stater, 98122
        • Swedish Medical Center-First Hill
      • Vancouver, Washington, Forente stater, 98664
        • PeaceHealth Southwest Medical Center
    • West Virginia
      • Charleston, West Virginia, Forente stater, 25304
        • Vandalia Health/CAMC Institute for Academic Medicine
    • Wisconsin
      • Antigo, Wisconsin, Forente stater, 54409
        • Aspirus Cancer Care-Antigo-Volm Cancer Center
      • Appleton, Wisconsin, Forente stater, 54911
        • ThedaCare Regional Cancer Center
      • Burlington, Wisconsin, Forente stater, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Eau Claire, Wisconsin, Forente stater, 54701
        • HSHS Sacred Heart Hospital
      • Eau Claire, Wisconsin, Forente stater, 54701
        • Marshfield Clinic Cancer Center at Sacred Heart
      • Germantown, Wisconsin, Forente stater, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, Forente stater, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, Forente stater, 54311
        • Aurora BayCare Medical Center
      • Green Bay, Wisconsin, Forente stater, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, Forente stater, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • Green Bay, Wisconsin, Forente stater, 54301
        • Bellin Memorial Hospital
      • Green Bay, Wisconsin, Forente stater, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Johnson Creek, Wisconsin, Forente stater, 53038
        • University of Wisconsin Carbone Cancer Center - Johnson Creek
      • Kenosha, Wisconsin, Forente stater, 53142
        • Aurora Cancer Care-Kenosha South
      • La Crosse, Wisconsin, Forente stater, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Forente stater, 53792
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, Forente stater, 53715
        • SSM Health Dean Medical Group - South Madison Campus
      • Manitowoc, Wisconsin, Forente stater, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, Forente stater, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marinette, Wisconsin, Forente stater, 54143
        • Bay Area Medical Center
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Medical Center-Marshfield
      • Marshfield, Wisconsin, Forente stater, 54449
        • Marshfield Medical Center
      • Milwaukee, Wisconsin, Forente stater, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, Forente stater, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, Forente stater, 53233
        • Aurora Sinai Medical Center
      • Minocqua, Wisconsin, Forente stater, 54548
        • Marshfield Medical Center - Minocqua
      • New Richmond, Wisconsin, Forente stater, 54017
        • Cancer Center of Western Wisconsin
      • Oconomowoc, Wisconsin, Forente stater, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, Forente stater, 54154
        • Saint Vincent Hospital Cancer Center at Oconto Falls
      • Oshkosh, Wisconsin, Forente stater, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, Forente stater, 53406
        • Aurora Cancer Care-Racine
      • Rhinelander, Wisconsin, Forente stater, 54501
        • Saint Mary's Hospital
      • Rhinelander, Wisconsin, Forente stater, 54501
        • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
      • Rice Lake, Wisconsin, Forente stater, 54868
        • Marshfield Medical Center-Rice Lake
      • Rice Lake, Wisconsin, Forente stater, 54868
        • Lakeview Medical Center-Marshfield Clinic
      • Sheboygan, Wisconsin, Forente stater, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Stevens Point, Wisconsin, Forente stater, 54481
        • Aspirus Cancer Care - Stevens Point
      • Summit, Wisconsin, Forente stater, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, Forente stater, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha, Wisconsin, Forente stater, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, Forente stater, 53188
        • ProHealth Waukesha Memorial Hospital
      • Waukesha, Wisconsin, Forente stater, 53188
        • Aurora Cancer Care-Waukesha
      • Wausau, Wisconsin, Forente stater, 54401
        • Marshfield Clinic-Wausau Center
      • Wausau, Wisconsin, Forente stater, 54401
        • Aspirus Cancer Care-Wausau
      • Wauwatosa, Wisconsin, Forente stater, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, Forente stater, 53227
        • Aurora West Allis Medical Center
      • Weston, Wisconsin, Forente stater, 54476
        • Marshfield Medical Center - Weston
      • Wisconsin Rapids, Wisconsin, Forente stater, 54494
        • Aspirus Cancer Care - Wisconsin Rapids
      • Wisconsin Rapids, Wisconsin, Forente stater, 54494
        • Marshfield Clinic - Wisconsin Rapids Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • PRE-REGISTRATION (STEP 0)
  • Histologically confirmed DLBCL expressing CD20 antigen; patients with transformed lymphoma are excluded; in this regard, patients with composite lymphoma in the diagnostic tissue (concomitant DLBCL and follicular or other low-grade lymphoma component) are excluded; however, patients with DLBCL in primary diagnostic tissue but a bone marrow that shows low grade or indeterminate lymphoma are eligible; patients with known primary mediastinal large B-cell lymphoma (PMLBCL) are excluded; similarly, patients with known c-myc translocation (by fluorescence in situ hybridization) positive DLBCL are encouraged to participate in trials specifically designed for these patients; however patients with known c-myc DLBC positive are NOT excluded from this study; c-myc testing prior to study enrollment is NOT required
  • Stages II bulky disease (defined as mass size of more than 10 cm), stage III, or IV (Ann Arbor staging); patients with stage I and stage II non-bulky disease are excluded from this study
  • A paraffin-embedded tumor tissue specimen from the initial diagnostic biopsy has been located and ready to ship to the Mayo Clinic Lymphoma Laboratory following pre-registration; Note: excisional tumor biopsy is preferred; core needle biopsies will be considered adequate if there is enough tissue for the mandatory central pathology review immunohistochemistry and Genomics Education Partnership (GEP); submission of a tumor block is preferred, but if unavailable submit alternative materials
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Previously untreated and not receiving any other agent that would be considered as a treatment for the lymphoma; for subjects with severe systemic symptoms, compressive disease, or rapidly progressing symptomatic adenopathy, are allowed for lymphoma associated symptom treatment with up to 1 mg/kg/day prednisone, or equivalent, for a maximum of 7 days is permitted prior to beginning the treatment, at the discretion of the investigator; a washout period does not apply
  • No known central nervous system (CNS) lymphoma or cerebrospinal fluid involvement with malignant lymphoma cells; these patients are usually treated with CNS directed therapy; screening for cerebrospinal fluid (CSF)/CNS involvement is NOT required but can be performed per treating medical doctor (MD) discretion; intrathecal (IT) methotrexate or IT cytarabine prophylaxis in patients with negative CSF who are felt to be at high risk of CNS relapse is allowed per local MD discretion; this should be noted on the treatment form
  • Absence of history of myocardial infarction =< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Absence of history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia; patients with a history of deep vein thrombosis(DVT)/pulmonary embolism (PE) or thrombophilia may participate if they are willing to be on full anticoagulation during the treatment if randomized to rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R2CHOP) arm A; full anticoagulation is defined as warfarin, factor X inhibitors, or low molecular weight heparin at therapeutic doses
  • Patient must be able and willing to receive anticoagulation therapy with aspirin 70-325 mg daily prophylaxis, low molecular weight heparin, factor X inhibitors or warfarin; patients unable or unwilling to take any prophylaxis are NOT eligible
  • Absence of history of acquired immune deficiency syndrome (AIDS)-related conditions (other than the presenting DLBCL) or post-transplant lymphoproliferative disorder (PTLD) in immunocompromised patients; patients with human immunodeficiency virus (HIV) on antiretroviral therapy other than zidovudine (AZT) and/or stavudine and without prior AIDS defining conditions and adequate CD4 count (> 400) are eligible
  • No other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy; exceptions to this are as follows: localized non-melanotic skin cancer and any cancer that in the judgment of the investigator has been treated with curative intent and will not interfere with the study treatment plan and response assessment
  • No history of radiation therapy to >= 25% of the bone marrow for other diseases or history of anthracycline therapy
  • Patients must not be receiving erythroid stimulating agents (EPO: Procrit, Aranesp)
  • RANDOMIZATION (STEP 1)
  • Patient meets the eligibility criteria outlined above
  • Site has received notification from Mayo Clinic - Rochester Division of Hematopathology of the central confirmation of diagnosis and tissue adequacy for mandatory research studies
  • Patients must have measurable disease (at least 1 lesion of >= 1.5 cm in one diameter) as detected by computed tomography (CT) or the CT images of the positron emission tomography (PET)/CT
  • International Prognostic Index (IPI) of 2 or greater
  • Ejection fraction of >= 45% by either multi-gated acquisition (MUGA) scan or echocardiogram (ECHO)
  • Absence of co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Absolute neutrophil count (ANC) >= 1500
  • Platelets (PLT) >= 100,000
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN, the direct bilirubin must be normal
  • Alkaline (Alk.) phosphatase =< 3 x ULN unless evidence of the direct liver involvement by lymphoma - then =< 5 x ULN
  • Aspartate aminotransferase (AST) =< 3 x ULN unless evidence of the direct liver involvement by lymphoma - then =< 5 x ULN
  • Creatinine =< 2 x ULN or creatinine clearance (CrCl) > 30 ml/min
  • Women must not be pregnant or breast-feeding
  • 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 prior to and again within 24 hours of starting 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; a female of childbearing potential is any woman, regardless of sexual orientation or 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 for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A (rituximab, combination chemotherapy, lenalidomide)

Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1; prednisone PO on days 1-5; and lenalidomide PO on days 1-10. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Annen: Laboratory Biomarker Analysis

Correlative studies

Legemiddel: Cyclophosphamide

Given IV

Andre navn:
  • Cytoksan
  • CTX
  • (-)-cyklofosfamid
  • 2H-1,3,2-oksazafosforin, 2-[bis(2-kloretyl)amino]tetrahydro-, 2-oksid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciklofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Sykloblastin
  • Cyclofosfam
  • Cyklofosfamid monohydrat
  • Cyclophosphamidum
  • Syklofosfan
  • Cyclophosphanum
  • Syklostin
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Legemiddel: Doxorubicin Hydrochloride

Given IV

Andre navn:
  • Adriamycin
  • 5,12-naftacendion, 10-[(3-amino-2,3,6-trideoksy-alfa-L-lyxo-heksopyranosyl)oksy]-7,8, 9,10-tetrahydro-6,8,11-trihydroksy -8-(hydroksyacetyl)-1-metoksy-, hydroklorid, (8S-cis)- (9Cl)
  • ADM
  • Adriacin
  • Adriamycin hydroklorid
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROKLORID
  • Adriblastina
  • Adriblastin
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroksydaunorubicin
  • Rubex
  • FI106
Legemiddel: Prednisone

Given PO

Andre navn:
  • Deltasone
  • Orasone
  • 61-kortison
  • 1,2-dehydrokortison
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-kortison
  • Delta-Dome
  • Deltacortene
  • Deltakortison
  • Deltadehydrokortison
  • Deltison
  • Delta
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metakortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednison
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednison Intensol
  • Prednisonum
  • Predniton
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednison
Legemiddel: Lenalidomide

Given PO

Andre navn:
  • CC-5013
  • Revlimid
  • CC5013
  • CDC 501
  • CC 5013
Biologisk: Rituximab

Given IV

Andre navn:
  • Rituxan
  • MabThera
  • ABP 798
  • BI 695500
  • C2B8 monoklonalt antistoff
  • Kimerisk anti-CD20 antistoff
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 monoklonalt antistoff
  • Monoklonalt antistoff IDEC-C2B8
  • PF-05280586
  • Riabni
  • Rituximab ABBS
  • Rituximab ARRX
  • Rituximab Biosimilar ABP 798
  • Rituximab Biosimilar BI 695500
  • Rituximab Biosimilar CT-P10
  • Rituximab Biosimilar GB241
  • Rituximab Biosimilar IBI301
  • Rituximab Biosimilar JHL1101
  • Rituximab Biosimilar PF-05280586
  • Rituximab Biosimilar RTXM83
  • Rituximab Biosimilar SAIT101
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • Rituximab PVVR
  • Rituximab-arrx
  • Rituximab-pvvr
  • RTXM83
  • Ruxience
  • Truxima
  • Rixathon
  • Ikgdar
  • Mabtas
  • Rituximab-abbs
  • BI-695500
  • BI695500
  • Blitzima
  • IDEC 102
  • IDEC102
  • PF 05280586
  • PF05280586
  • Ritemvia
  • Rituximab-blit
  • Rituximab-rite
  • Rituximab-rixa
  • Rituximab-rixi
  • Riximyo
  • RTXM 83
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • GP 2013
  • GP-2013
  • GP2013
  • Rituximab Biosimilar GP2013
Legemiddel: Vincristine Sulfate

Given IV

Andre navn:
  • Oncovin
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vinkristin, sulfat
Aktiv komparator: Arm B (rituximab, combination chemotherapy)

Patients receive rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone as in Arm A. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Annen: Laboratory Biomarker Analysis

Correlative studies

Legemiddel: Cyclophosphamide

Given IV

Andre navn:
  • Cytoksan
  • CTX
  • (-)-cyklofosfamid
  • 2H-1,3,2-oksazafosforin, 2-[bis(2-kloretyl)amino]tetrahydro-, 2-oksid, monohydrat
  • Carloxan
  • Ciclofosfamida
  • Ciklofosfamid
  • Cicloxal
  • Clafen
  • Claphene
  • CP monohydrat
  • CYCLO-celle
  • Sykloblastin
  • Cyclofosfam
  • Cyklofosfamid monohydrat
  • Cyclophosphamidum
  • Syklofosfan
  • Cyclophosphanum
  • Syklostin
  • Cytofosfan
  • Fosfaseron
  • Genoxal
  • Genuxal
  • Ledoxina
  • Mitoxan
  • Neosar
  • Revimmune
  • Syklofosfamid
  • WR- 138719
  • Asta B 518
  • B-518
  • WR-138719
  • B 518
  • B518
  • WR 138719
  • WR138719
  • Frindovyx
Legemiddel: Doxorubicin Hydrochloride

Given IV

Andre navn:
  • Adriamycin
  • 5,12-naftacendion, 10-[(3-amino-2,3,6-trideoksy-alfa-L-lyxo-heksopyranosyl)oksy]-7,8, 9,10-tetrahydro-6,8,11-trihydroksy -8-(hydroksyacetyl)-1-metoksy-, hydroklorid, (8S-cis)- (9Cl)
  • ADM
  • Adriacin
  • Adriamycin hydroklorid
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROKLORID
  • Adriblastina
  • Adriblastin
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin HCl
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroksydaunorubicin
  • Rubex
  • FI106
Legemiddel: Prednisone

Given PO

Andre navn:
  • Deltasone
  • Orasone
  • 61-kortison
  • 1,2-dehydrokortison
  • Adasone
  • Cortancyl
  • Dacortin
  • DeCortin
  • Decortisyl
  • Decorton
  • Delta 1-kortison
  • Delta-Dome
  • Deltacortene
  • Deltakortison
  • Deltadehydrokortison
  • Deltison
  • Delta
  • Econosone
  • Lisacort
  • Meprosona-F
  • Metakortandracin
  • Meticorten
  • Ofisolona
  • Panafcort
  • Panasol-S
  • Paracort
  • Perrigo Prednison
  • PRED
  • Predicor
  • Predicorten
  • Prednicen-M
  • Prednicort
  • Prednidib
  • Prednilonga
  • Predniment
  • Prednison Intensol
  • Prednisonum
  • Predniton
  • Promifen
  • Rayos
  • Servisone
  • SK-Prednison
Biologisk: Rituximab

Given IV

Andre navn:
  • Rituxan
  • MabThera
  • ABP 798
  • BI 695500
  • C2B8 monoklonalt antistoff
  • Kimerisk anti-CD20 antistoff
  • CT-P10
  • IDEC-102
  • IDEC-C2B8
  • IDEC-C2B8 monoklonalt antistoff
  • Monoklonalt antistoff IDEC-C2B8
  • PF-05280586
  • Riabni
  • Rituximab ABBS
  • Rituximab ARRX
  • Rituximab Biosimilar ABP 798
  • Rituximab Biosimilar BI 695500
  • Rituximab Biosimilar CT-P10
  • Rituximab Biosimilar GB241
  • Rituximab Biosimilar IBI301
  • Rituximab Biosimilar JHL1101
  • Rituximab Biosimilar PF-05280586
  • Rituximab Biosimilar RTXM83
  • Rituximab Biosimilar SAIT101
  • Rituximab Biosimilar SIBP-02
  • rituximab biosimilar TQB2303
  • Rituximab PVVR
  • Rituximab-arrx
  • Rituximab-pvvr
  • RTXM83
  • Ruxience
  • Truxima
  • Rixathon
  • Ikgdar
  • Mabtas
  • Rituximab-abbs
  • BI-695500
  • BI695500
  • Blitzima
  • IDEC 102
  • IDEC102
  • PF 05280586
  • PF05280586
  • Ritemvia
  • Rituximab-blit
  • Rituximab-rite
  • Rituximab-rixa
  • Rituximab-rixi
  • Riximyo
  • RTXM 83
  • RTXM-83
  • ABP-798
  • ABP798
  • CT P10
  • CTP10
  • GP 2013
  • GP-2013
  • GP2013
  • Rituximab Biosimilar GP2013
Legemiddel: Vincristine Sulfate

Given IV

Andre navn:
  • Oncovin
  • Kyocristine
  • Leurocristine Sulfate
  • Leurocristine, sulfat
  • Vincasar
  • Vincosid
  • Vincrex
  • Vinkristin, sulfat

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
3-year Progression-free Survival Rate
Tidsramme: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10, 3-year PFS rate reported

Progression-free survival is defined as the time from randomization to disease progression, new primary of the same type or death, whichever occurs first. Progressive disease is defined as:

  • Appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size.

  • >= 50% increase from nadir in the sum of the product of the diameters 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 > 1 cm in its short axis.

  • Lesions should be PET positive unless the lesion is too small to be detected with current PET systems.

  • Measurable extranodal disease should be assessed in a manner similar to that for nodal disease.

    3-year progression-free survival rate was calculated using Kaplan-Meier method.
Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10, 3-year PFS rate reported

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of Patients With Response
Tidsramme: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10

Response is defined as complete response (CR) or partial response (PR) CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms

PR:

  • >=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
  • No new sites of disease
  • The post-treatment PET should be positive at any previously involved sites
  • For variably FDG-avid lymphomas/FDG-avidity unknown, without a pretreatment PET scan, or if a pretreatment PET scan was negative, CT scan criteria should be used
  • Patients with a CR and persistent morphologic bone marrow involvement
  • Patients with bone marrow involved before therapy and a clinical CR but no bone marrow assessment after treatment
Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10
Proportion of Patients With Complete Response
Tidsramme: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10

Complete response is defined as complete disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.
Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10
Overall Survival Rate at 3 Years
Tidsramme: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10

Overall survival is defined as time from randomization to death or date last known alive. Overall survival rate at 3 years was calculated using the method of Kaplan Meier.
Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Innvirkning av DLBCL Molecular Subtype på utfallet.
Tidsramme: Vurdert ved baseline, hver 3. måned i 2 år, hver 6. måned i år 3, og deretter årlig i år 4-10
Vurdert ved baseline, hver 3. måned i 2 år, hver 6. måned i år 3, og deretter årlig i år 4-10
Interim PET Scan Results in Relation to Treatment Outcome
Tidsramme: Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10
  • To evaluate the association between the binary score of baseline SUV and PFS.
  • To evaluate the association between the binary score of % change in standard uptake value (SUVs) from PET3 to baseline and PFS.
Assessed every 3 months for 2 years, every 6 months for year 3, and then annually for years 4-10

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute (NCI)

Etterforskere

  • Hovedetterforsker: Grzegorz S Nowakowski, ECOG-ACRIN Cancer Research Group

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. august 2013

Primær fullføring (Faktiske)

26. mars 2020

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

14. mai 2013

Først innsendt som oppfylte QC-kriteriene

14. mai 2013

Først lagt ut (Antatt)

17. mai 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NCI-2013-00959
  • U10CA180820 (U.S. NIH-stipend/kontrakt)
  • U24CA196172 (U.S. NIH-stipend/kontrakt)
  • U10CA021115 (U.S. NIH-stipend/kontrakt)
  • NCI-2013-00959 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
  • ECOG-E1412
  • S13-01316
  • E1412 (Annen identifikator: CTEP)
  • E1412
  • E1412 (Annen identifikator: ECOG-ACRIN Cancer Research Group)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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