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Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission

Sponsor
ECOG-ACRIN Cancer Research Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT03267433
Collaborator
National Cancer Institute (NCI) (NIH)
689
Enrollment
319
Locations
2
Arms
173.1
Anticipated Duration (Months)
2.2
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Autologous Hematopoietic Stem Cell Transplantation
  • Other: Laboratory Biomarker Analysis
  • Biological: Rituximab
 Phase 3

Detailed Description

PRIMARY OBJECTIVES:
  1. To compare overall survival in mantle cell lymphoma (MCL) patients in minimal residual disease (MRD)-negative first remission who undergo autologous hematopoietic stem cell transplantation (auto-HCT) followed by maintenance rituximab versus (vs.) maintenance rituximab alone (without auto-HCT).
SECONDARY OBJECTIVES:

  1. To compare progression-free survival in MCL patients in MRD-negative first remission who undergo auto-HCT followed by maintenance rituximab vs. maintenance rituximab alone.

  2. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive (or MRD-indeterminate) patients who undergo auto-HCT followed by 2 years of maintenance rituximab.

  3. To describe the rate of complications (serious infection, hospitalization, need for intravenous immune globulin) in MCL patients undergoing maintenance rituximab following auto-HCT.

  4. To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive prior to auto-HCT.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 60-120 days after transplant, patients receive rituximab intravenously (IV) once every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive standard of care induction chemotherapy. Beginning 40-120 days after completion of chemotherapy, patients receive rituximab as in Group I.

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
689 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase III Trial of Consolidation With Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients With Mantle Cell Lymphoma in Minimal Residual Disease-Negative First Complete Remission
Actual Study Start Date :
Aug 29, 2017
Anticipated Primary Completion Date :
Jan 31, 2027
Anticipated Study Completion Date :
Jan 31, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group I (auto-HCT, rituximab)

Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 60-120 days after transplant, patients receive rituximab IV once every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Procedure: Autologous Hematopoietic Stem Cell Transplantation
Undergo HCT
Other Names:
  • Autologous Hematopoietic Cell Transplantation
  • autologous stem cell transplantation

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Biological: Rituximab
    Given IV
    Experimental: Group II (rituximab alone)

    Patients receive standard of care induction chemotherapy. Beginning 40-120 days after completion of chemotherapy, patients receive rituximab as in Group I.

    Other: Laboratory Biomarker Analysis
    Correlative studies

    Biological: Rituximab
    Given IV

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival (OS) in MCL patients in MRD-negative first remission who undergo auto-HCT followed by rituximab vs. maintenance rituximab alone [Time between randomization and death from any cause, assessed up to 10 years]

      The Kaplan-Meier method will be used to estimate OS, including medians and confidence intervals. Comparison of OS between treatment arms will be conducted using a one-sided log-rank test stratified with mantle cell lymphoma International Prognostic Index (MIPI)-c score and induction regimen.

    Secondary Outcome Measures

    1. Incidence of adverse events evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [Up to 10 years]

      The primary safety analysis will be based on the toxicity population, and the analysis will be performed by treatment received.

    2. MRD status in MCL patients who were MRD-positive prior to auto-HCT [At 100 days]

      Will be reported together with confidence intervals.

    3. OS in MRD-positive patients (or patients in PR) who undergo auto-HCT followed by rituximab [Time between randomization and death from any cause, assessed up to 10 years]

      Will be estimated by the method of Kaplan and Meier.

    4. PFS in MRD-positive patients (or patients in PR) who undergo auto-HCT followed by rituximab [From randomization to the earliest of documented disease progression or death without progression, assessed up to 10 years]

      Will be estimated by the method of Kaplan and Meier.

    5. Progression-free survival (PFS) in MCL patients in MRD-negative first remission who undergo auto-HCT followed by rituximab vs rituximab alone [From randomization to the earliest of documented disease progression or death without progression, assessed up to 10 years]

      The method of Kaplan and Meier will be used to estimate PFS, and stratified log-rank test will be used to compare PFS between two arms.

    6. Rate of complications in MCL patients undergoing maintenance rituximab [Up to 10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • INCLUSION CRITERIA FOR SCREENING (STEP 0 - PREREGISTRATION)

    • Patients must have histologically confirmed mantle cell lymphoma, with cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or FISH. If patient has cyclin D1 negative mantle cell lymphoma with classical morphology and an expression profile (including SOX11+) that is otherwise indistinguishable from mantle cell lymphoma, communication with investigator is required for consideration of enrollment. The proliferation rate, using Ki-67 or MIB-1, should also be determined, but is not required until Step 1 registration. Patients may register to Step 0 without a documented Ki-67 index.

    • Patients should be deemed to be potentially eligible and willing candidates for auto-HCT by the enrolling physician

    • Patient may be receiving or have completed induction therapy within 60 days prior to preregistration to step 0; no more than 300 days may have passed between the first day of induction therapy and preregistration to step 0

    • For patients who have completed induction therapy, restaging evaluation must show status of partial (PR) or complete response (CR); patients preregistered post-induction with evidence of clinical disease progression are not eligible for preregistration

    • Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy

    • NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to rituximab(R)-cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP) (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-dexamethasone, high-dose cytarabine, and cisplatin (DHAP) as a planned induction regimen would count as one regimen

    • Patient does not have any documented history of central nervous system (CNS) involvement by mantle cell lymphoma; this includes no evidence of parenchymal brain, spinal cord, or cerebrospinal fluid involvement; radiculopathy symptoms from nerve root compression by lymphoma do not constitute CNS involvement

    • Patient must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy available for submission to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence

    • NOTE: Patients for whom the molecular marker is identified will have peripheral blood collected after completion of induction (patient?s disease status is PR or CR) and submitted to Adaptive Biotechnologies for minimal residual disease (MRD) assessment

    • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1)

    • Patients must have met eligibility criteria for the screening step

    • Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria:

    • Patients are ?MRD Indeterminate?: ClonoSEQ ID molecular marker assessment did not identify any unique clonal immunoglobulin DNA sequence OR

    • ClonoSEQ ID molecular marker assessment identified unique clonal immunoglobulin DNA sequence and MRD assessment is completed

    • Patients must have completed induction therapy within 120 days prior to preregistration to step 0, AND no more than 300 days may have elapsed from the first dose of induction chemotherapy (cycle 1 [C1] day 1 [D1]) given, until the last day of induction chemotherapy administered; for those assigned to Arms A, C, or D, the date of transplant (?day 0?) must not be greater than 365 days after the first dose of induction chemotherapy (C1D1) given

    • Patient must have received at least four (4) cycles of induction therapy

    • Up to two regimens of chemotherapy are allowed as long as a continuous response was ongoing throughout therapy

    • NOTE: For example, a patient who started treatment with rituximab/bendamustine and was then switched to R-CHOP (due to insufficient response or excessive toxicity) would be counted as having received 2 regimens; however, R-CHOP alternating with R-DHAP as a planned induction regimen would count as one regimen

    • Patients must have achieved a radiologic complete or partial remission as defined by the Lugano criteria

    • Patients must meet institutional eligibility requirements for stem cell transplant, including cardiac, renal, liver, and pulmonary requirements

    • Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

    • Human immunodeficiency virus (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/mm^3

    • No history of acquired immune deficiency syndrome (AIDS)-defining conditions

    • Patient must be disease-free >= 3 years of prior malignancies with the exception of adequately treated non-melanoma skin cancer, adequately treated in situ carcinoma, low grade prostate carcinoma (Gleason grade =< 6) managed with observation that has been stable for at least 6 months

    • Women must not be pregnant or breast-feeding

    • All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy

    • 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)
    • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Cancer Center Birmingham Alabama United States 35233
    2 Anchorage Associates in Radiation Medicine Anchorage Alaska United States 98508
    3 Anchorage Radiation Therapy Center Anchorage Alaska United States 99504
    4 Alaska Breast Care and Surgery LLC Anchorage Alaska United States 99508
    5 Alaska Oncology and Hematology LLC Anchorage Alaska United States 99508
    6 Alaska Women's Cancer Care Anchorage Alaska United States 99508
    7 Anchorage Oncology Centre Anchorage Alaska United States 99508
    8 Katmai Oncology Group Anchorage Alaska United States 99508
    9 Providence Alaska Medical Center Anchorage Alaska United States 99508
    10 Fairbanks Memorial Hospital Fairbanks Alaska United States 99701
    11 Kingman Regional Medical Center Kingman Arizona United States 86401
    12 University of Arizona Cancer Center-Orange Grove Campus Tucson Arizona United States 85704
    13 Banner University Medical Center - Tucson Tucson Arizona United States 85719
    14 University of Arizona Cancer Center-North Campus Tucson Arizona United States 85719
    15 PCR Oncology Arroyo Grande California United States 93420
    16 Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California United States 91505
    17 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    18 UC San Diego Moores Cancer Center La Jolla California United States 92093
    19 UCSF Medical Center-Parnassus San Francisco California United States 94143
    20 Rocky Mountain Cancer Centers-Aurora Aurora Colorado United States 80012
    21 The Medical Center of Aurora Aurora Colorado United States 80012
    22 Boulder Community Hospital Boulder Colorado United States 80301
    23 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
    24 Cancer Center of Colorado at Sloan's Lake Denver Colorado United States 80204
    25 Denver Health Medical Center Denver Colorado United States 80204
    26 National Jewish Health-Main Campus Denver Colorado United States 80206
    27 The Women's Imaging Center Denver Colorado United States 80209
    28 Colorado Blood Cancer Institute Denver Colorado United States 80218
    29 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
    30 Rocky Mountain Cancer Centers-Midtown Denver Colorado United States 80218
    31 SCL Health Saint Joseph Hospital Denver Colorado United States 80218
    32 Rocky Mountain Cancer Centers-Rose Denver Colorado United States 80220
    33 Rose Medical Center Denver Colorado United States 80220
    34 Mountain Blue Cancer Care Center - Swedish Englewood Colorado United States 80113
    35 Swedish Medical Center Englewood Colorado United States 80113
    36 National Jewish Health-Western Hematology Oncology Golden Colorado United States 80401
    37 Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado United States 81501
    38 Grand Valley Oncology Grand Junction Colorado United States 81505
    39 North Colorado Medical Center Greeley Colorado United States 80631
    40 Rocky Mountain Cancer Centers-Greenwood Village Greenwood Village Colorado United States 80111
    41 Good Samaritan Medical Center Lafayette Colorado United States 80026
    42 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
    43 Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado United States 80124
    44 Sky Ridge Medical Center Lone Tree Colorado United States 80124
    45 McKee Medical Center Loveland Colorado United States 80539
    46 National Jewish Health-Northern Hematology Oncology Thornton Colorado United States 80260
    47 SCL Health Lutheran Medical Center Wheat Ridge Colorado United States 80033
    48 Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut United States 06105
    49 Smilow Cancer Center/Yale-New Haven Hospital New Haven Connecticut United States 06510
    50 Yale University New Haven Connecticut United States 06520
    51 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    52 Baptist MD Anderson Cancer Center Jacksonville Florida United States 32207
    53 Mayo Clinic in Florida Jacksonville Florida United States 32224-9980
    54 University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida United States 33136
    55 Moffitt Cancer Center-International Plaza Tampa Florida United States 33607
    56 Moffitt Cancer Center - McKinley Campus Tampa Florida United States 33612
    57 Moffitt Cancer Center Tampa Florida United States 33612
    58 Emory University Hospital/Winship Cancer Institute Atlanta Georgia United States 30322
    59 Emory Saint Joseph's Hospital Atlanta Georgia United States 30342
    60 Augusta University Medical Center Augusta Georgia United States 30912
    61 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
    62 Saint Luke's Mountain States Tumor Institute Boise Idaho United States 83712
    63 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
    64 Kootenai Medical Center Coeur d'Alene Idaho United States 83814
    65 Walter Knox Memorial Hospital Emmett Idaho United States 83617
    66 Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland Idaho United States 83619
    67 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
    68 Saint Luke's Mountain States Tumor Institute - Meridian Meridian Idaho United States 83642
    69 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
    70 Saint Luke's Mountain States Tumor Institute - Nampa Nampa Idaho United States 83686
    71 Kootenai Cancer Center Post Falls Idaho United States 83854
    72 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
    73 Saint Luke's Mountain States Tumor Institute-Twin Falls Twin Falls Idaho United States 83301
    74 Loyola Center for Health at Burr Ridge Burr Ridge Illinois United States 60527
    75 Northwestern University Chicago Illinois United States 60611
    76 Rush University Medical Center Chicago Illinois United States 60612
    77 University of Chicago Comprehensive Cancer Center Chicago Illinois United States 60637
    78 Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois United States 60115
    79 Northwestern Medicine Cancer Center Delnor Geneva Illinois United States 60134
    80 Northwestern Medicine Lake Forest Hospital Lake Forest Illinois United States 60045
    81 Loyola University Medical Center Maywood Illinois United States 60153
    82 Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park Illinois United States 60160
    83 UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois United States 60451
    84 Loyola Center for Cancer Care and Research Orland Park Illinois United States 60462
    85 University of Chicago Medicine-Orland Park Orland Park Illinois United States 60462
    86 Northwestern Medicine Cancer Center Warrenville Warrenville Illinois United States 60555
    87 Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana United States 46202
    88 Sidney and Lois Eskenazi Hospital Indianapolis Indiana United States 46202
    89 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
    90 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
    91 Cancer Center of Kansas - El Dorado El Dorado Kansas United States 67042
    92 Cancer Center of Kansas - Fort Scott Fort Scott Kansas United States 66701
    93 Cancer Center of Kansas-Independence Independence Kansas United States 67301
    94 Cancer Center of Kansas-Kingman Kingman Kansas United States 67068
    95 Lawrence Memorial Hospital Lawrence Kansas United States 66044
    96 Cancer Center of Kansas-Liberal Liberal Kansas United States 67905
    97 Cancer Center of Kansas-Manhattan Manhattan Kansas United States 66502
    98 Cancer Center of Kansas - McPherson McPherson Kansas United States 67460
    99 Cancer Center of Kansas - Newton Newton Kansas United States 67114
    100 Cancer Center of Kansas - Parsons Parsons Kansas United States 67357
    101 Cancer Center of Kansas - Pratt Pratt Kansas United States 67124
    102 Cancer Center of Kansas - Salina Salina Kansas United States 67401
    103 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
    104 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
    105 Associates In Womens Health Wichita Kansas United States 67208
    106 Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas United States 67208
    107 Ascension Via Christi Hospitals Wichita Wichita Kansas United States 67214
    108 Cancer Center of Kansas - Wichita Wichita Kansas United States 67214
    109 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
    110 University of Kentucky/Markey Cancer Center Lexington Kentucky United States 40536
    111 The James Graham Brown Cancer Center at University of Louisville Louisville Kentucky United States 40202
    112 Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland United States 21287
    113 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    114 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    115 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    116 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109
    117 Huron Medical Center PC Port Huron Michigan United States 48060
    118 Lake Huron Medical Center Port Huron Michigan United States 48060
    119 Mayo Clinic Rochester Minnesota United States 55905
    120 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
    121 Saint Louis University Hospital Saint Louis Missouri United States 63110
    122 Washington University School of Medicine Saint Louis Missouri United States 63110
    123 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
    124 Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri United States 63376
    125 Community Hospital of Anaconda Anaconda Montana United States 59711
    126 Billings Clinic Cancer Center Billings Montana United States 59101
    127 Saint Vincent Healthcare Billings Montana United States 59101
    128 Saint Vincent Frontier Cancer Center Billings Montana United States 59102
    129 Bozeman Deaconess Hospital Bozeman Montana United States 59715
    130 Saint James Community Hospital and Cancer Treatment Center Butte Montana United States 59701
    131 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
    132 Great Falls Clinic Great Falls Montana United States 59405
    133 Saint Peter's Community Hospital Helena Montana United States 59601
    134 Kalispell Regional Medical Center Kalispell Montana United States 59901
    135 Saint Patrick Hospital - Community Hospital Missoula Montana United States 59802
    136 Community Medical Hospital Missoula Montana United States 59804
    137 Nebraska Medicine-Bellevue Bellevue Nebraska United States 68123
    138 Nebraska Medicine-Village Pointe Omaha Nebraska United States 68118
    139 University of Nebraska Medical Center Omaha Nebraska United States 68198
    140 Carson Tahoe Regional Medical Center Carson City Nevada United States 89703
    141 Cancer and Blood Specialists-Henderson Henderson Nevada United States 89052
    142 Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada United States 89052
    143 Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada United States 89052
    144 Las Vegas Cancer Center-Henderson Henderson Nevada United States 89052
    145 OptumCare Cancer Care at Seven Hills Henderson Nevada United States 89052
    146 21st Century Oncology-Henderson Henderson Nevada United States 89074
    147 Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada United States 89074
    148 Las Vegas Urology - Green Valley Henderson Nevada United States 89074
    149 Las Vegas Urology - Pebble Henderson Nevada United States 89074
    150 Urology Specialists of Nevada - Green Valley Henderson Nevada United States 89074
    151 Las Vegas Urology - Pecos Las Vegas Nevada United States 89074
    152 Desert West Surgery Las Vegas Nevada United States 89102
    153 OptumCare Cancer Care at Oakey Las Vegas Nevada United States 89102
    154 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    155 Hope Cancer Care of Nevada Las Vegas Nevada United States 89103
    156 Cancer and Blood Specialists-Shadow Las Vegas Nevada United States 89106
    157 Radiation Oncology Centers of Nevada Central Las Vegas Nevada United States 89106
    158 Urology Specialists of Nevada - Central Las Vegas Nevada United States 89106
    159 21st Century Oncology Las Vegas Nevada United States 89109
    160 HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada United States 89109
    161 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109
    162 HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada United States 89113
    163 Las Vegas Prostate Cancer Center Las Vegas Nevada United States 89113
    164 Las Vegas Urology - Sunset Las Vegas Nevada United States 89113
    165 Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada United States 89119
    166 21st Century Oncology-Vegas Tenaya Las Vegas Nevada United States 89128
    167 Ann M Wierman MD LTD Las Vegas Nevada United States 89128
    168 Cancer and Blood Specialists-Tenaya Las Vegas Nevada United States 89128
    169 Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada United States 89128
    170 HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada United States 89128
    171 Las Vegas Urology - Cathedral Rock Las Vegas Nevada United States 89128
    172 Las Vegas Urology - Smoke Ranch Las Vegas Nevada United States 89128
    173 OptumCare Cancer Care at MountainView Las Vegas Nevada United States 89128
    174 Urology Specialists of Nevada - Northwest Las Vegas Nevada United States 89128
    175 Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada United States 89135
    176 Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada United States 89144
    177 Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada United States 89144
    178 Summerlin Hospital Medical Center Las Vegas Nevada United States 89144
    179 Las Vegas Cancer Center-Medical Center Las Vegas Nevada United States 89148-2405
    180 21st Century Oncology-Fort Apache Las Vegas Nevada United States 89148
    181 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89148
    182 OptumCare Cancer Care at Fort Apache Las Vegas Nevada United States 89148
    183 Urology Specialists of Nevada - Southwest Las Vegas Nevada United States 89148
    184 HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada United States 89149
    185 Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada United States 89169
    186 University Cancer Center Las Vegas Nevada United States 89169
    187 Hope Cancer Care of Nevada-Pahrump Pahrump Nevada United States 89048
    188 Renown Regional Medical Center Reno Nevada United States 89502
    189 Saint Mary's Regional Medical Center Reno Nevada United States 89503
    190 Radiation Oncology Associates Reno Nevada United States 89509
    191 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    192 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903
    193 Roswell Park Cancer Institute Buffalo New York United States 14263
    194 Glens Falls Hospital Glens Falls New York United States 12801
    195 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    196 University of Rochester Rochester New York United States 14642
    197 UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina United States 27599
    198 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    199 Atrium Health Pineville/LCI-Pineville Charlotte North Carolina United States 28210
    200 Wake Forest University at Clemmons Clemmons North Carolina United States 27012
    201 Atrium Health Cabarrus/LCI-Concord Concord North Carolina United States 28025
    202 Duke University Medical Center Durham North Carolina United States 27710
    203 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
    204 University of Cincinnati/Barrett Cancer Center Cincinnati Ohio United States 45219
    205 Case Western Reserve University Cleveland Ohio United States 44106
    206 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    207 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
    208 University Pointe West Chester Ohio United States 45069
    209 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    210 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
    211 Saint Charles Health System Bend Oregon United States 97701
    212 Clackamas Radiation Oncology Center Clackamas Oregon United States 97015
    213 Providence Cancer Institute Clackamas Clinic Clackamas Oregon United States 97015
    214 Bay Area Hospital Coos Bay Oregon United States 97420
    215 Providence Newberg Medical Center Newberg Oregon United States 97132
    216 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
    217 Providence Portland Medical Center Portland Oregon United States 97213
    218 Providence Saint Vincent Medical Center Portland Oregon United States 97225
    219 Oregon Health and Science University Portland Oregon United States 97239
    220 Saint Charles Health System-Redmond Redmond Oregon United States 97756
    221 Geisinger Medical Center Danville Pennsylvania United States 17822
    222 University of Pennsylvania/Abramson Cancer Center Philadelphia Pennsylvania United States 19104
    223 University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania United States 15232
    224 Medical University of South Carolina Charleston South Carolina United States 29425
    225 Prisma Health Cancer Institute - Laurens Clinton South Carolina United States 29325
    226 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
    227 Saint Francis Hospital Greenville South Carolina United States 29601
    228 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
    229 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
    230 Prisma Health Greenville Memorial Hospital Greenville South Carolina United States 29605
    231 Saint Francis Cancer Center Greenville South Carolina United States 29607
    232 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
    233 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
    234 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
    235 Prisma Health Cancer Institute - Spartanburg Spartanburg South Carolina United States 29307
    236 Vanderbilt University/Ingram Cancer Center Nashville Tennessee United States 37232
    237 Houston Methodist Hospital Houston Texas United States 77030
    238 Methodist Willowbrook Hospital Houston Texas United States 77070
    239 Houston Methodist Sugar Land Hospital Sugar Land Texas United States 77479
    240 American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah United States 84003
    241 Sandra L Maxwell Cancer Center Cedar City Utah United States 84720
    242 Farmington Health Center Farmington Utah United States 84025
    243 Logan Regional Hospital Logan Utah United States 84321
    244 Intermountain Medical Center Murray Utah United States 84107
    245 McKay-Dee Hospital Center Ogden Utah United States 84403
    246 Utah Valley Regional Medical Center Provo Utah United States 84604
    247 Riverton Hospital Riverton Utah United States 84065
    248 Dixie Medical Center Regional Cancer Center Saint George Utah United States 84770
    249 Utah Cancer Specialists-Salt Lake City Salt Lake City Utah United States 84106
    250 Huntsman Cancer Institute/University of Utah Salt Lake City Utah United States 84112
    251 LDS Hospital Salt Lake City Utah United States 84143
    252 South Jordan Health Center South Jordan Utah United States 84009
    253 Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont United States 05602
    254 University of Vermont Medical Center Burlington Vermont United States 05401
    255 University of Vermont and State Agricultural College Burlington Vermont United States 05405
    256 University of Virginia Cancer Center Charlottesville Virginia United States 22908
    257 Providence Regional Cancer System-Aberdeen Aberdeen Washington United States 98520
    258 MultiCare Auburn Medical Center Auburn Washington United States 98001
    259 Overlake Hospital Medical Center Bellevue Washington United States 98004
    260 PeaceHealth Saint Joseph Medical Center Bellingham Washington United States 98225
    261 Providence Regional Cancer System-Centralia Centralia Washington United States 98531
    262 Swedish Cancer Institute-Edmonds Edmonds Washington United States 98026
    263 Providence Regional Cancer Partnership Everett Washington United States 98201
    264 MultiCare Gig Harbor Medical Park Gig Harbor Washington United States 98335
    265 Swedish Cancer Institute-Issaquah Issaquah Washington United States 98029
    266 Kadlec Clinic Hematology and Oncology Kennewick Washington United States 99336
    267 Providence Regional Cancer System-Lacey Lacey Washington United States 98503
    268 PeaceHealth Saint John Medical Center Longview Washington United States 98632
    269 Jefferson Healthcare Port Townsend Washington United States 98368
    270 MultiCare Good Samaritan Hospital Puyallup Washington United States 98372
    271 Valley Medical Center Renton Washington United States 98055
    272 Pacific Gynecology Specialists Seattle Washington United States 98104
    273 Swedish Medical Center-Ballard Campus Seattle Washington United States 98107
    274 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    275 Seattle Cancer Care Alliance Seattle Washington United States 98109
    276 Kaiser Permanente Washington Seattle Washington United States 98112
    277 Swedish Medical Center-First Hill Seattle Washington United States 98122-4307
    278 Swedish Medical Center-Cherry Hill Seattle Washington United States 98122-5711
    279 University of Washington Medical Center Seattle Washington United States 98195
    280 PeaceHealth United General Medical Center Sedro-Woolley Washington United States 98284
    281 Providence Regional Cancer System-Shelton Shelton Washington United States 98584
    282 MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley Washington United States 99216
    283 MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington United States 99204
    284 MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington United States 99218
    285 Mary Bridge Children's Hospital and Health Center Tacoma Washington United States 98405
    286 MultiCare Tacoma General Hospital Tacoma Washington United States 98405
    287 PeaceHealth Southwest Medical Center Vancouver Washington United States 98664
    288 Providence Saint Mary Regional Cancer Center Walla Walla Washington United States 99362
    289 Providence Regional Cancer System-Yelm Yelm Washington United States 98597
    290 United Hospital Center Bridgeport West Virginia United States 26330
    291 WVUH-Berkely Medical Center Martinsburg West Virginia United States 25401
    292 West Virginia University Healthcare Morgantown West Virginia United States 26506
    293 Camden Clark Medical Center Parkersburg West Virginia United States 26101
    294 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin United States 54729
    295 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
    296 Mayo Clinic Health System-Eau Claire Clinic Eau Claire Wisconsin United States 54701
    297 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    298 Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin United States 54303
    299 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    300 Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin United States 54848
    301 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    302 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    303 Marshfield Medical Center Marshfield Wisconsin United States 54449
    304 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    305 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
    306 ProHealth D N Greenwald Center Mukwonago Wisconsin United States 53149
    307 ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin United States 53066
    308 Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin United States 54154
    309 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
    310 Marshfield Clinic Stevens Point Center Stevens Point Wisconsin United States 54482
    311 Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin United States 54235-1495
    312 ProHealth Waukesha Memorial Hospital Waukesha Wisconsin United States 53188
    313 UW Cancer Center at ProHealth Care Waukesha Wisconsin United States 53188
    314 Marshfield Clinic-Wausau Center Wausau Wisconsin United States 54401
    315 Marshfield Clinic - Weston Center Weston Wisconsin United States 54476
    316 Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin United States 54494
    317 Cheyenne Regional Medical Center-West Cheyenne Wyoming United States 82001
    318 Billings Clinic-Cody Cody Wyoming United States 82414
    319 Welch Cancer Center Sheridan Wyoming United States 82801

    Sponsors and Collaborators

    • ECOG-ACRIN Cancer Research Group
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Timothy Fenske, ECOG-ACRIN Cancer Research Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ECOG-ACRIN Cancer Research Group
    ClinicalTrials.gov Identifier:
    NCT03267433
    Other Study ID Numbers:
    • EA4151
    • NCI-2016-01403
    • EA4151
    • EA4151
    • EA4151
    • U10CA180820
    First Posted:
    Aug 30, 2017
    Last Update Posted:
    Dec 23, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Mantle-Cell
    Neoplasm, Residual
    Rituximab

    Study Results

    No Results Posted as of Dec 23, 2021