Rituximab With or Without Stem Cell Transplant in Treating Patients With Minimal Residual Disease-Negative Mantle Cell Lymphoma in First Complete Remission
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
3 other identifiers
interventional
689
2 countries
375
Brief Summary
This 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. Immunotherapy with rituximab, may induce changes in body's immune system and may interfere with the ability of tumor 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2017
Longer than P75 for phase_3
375 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2017
CompletedFirst Posted
Study publicly available on registry
August 30, 2017
CompletedStudy Start
First participant enrolled
November 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2027
July 17, 2026
July 1, 2026
9.2 years
August 28, 2017
July 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS) in mantle cell lymphoma (MCL) patients in minimal residual disease (MRD)-negative complete remission (CR) who undergo auto-hematopoietic stem cell transplant (HCT) followed by rituximab versus (vs.) maintenance rituximab alone
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.
Time between randomization and death from any cause, assessed up to 10 years
Secondary Outcomes (6)
Progression-free survival (PFS) in MCL patients in MRD-negative CR 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
PFS in MRD-negative PR patients, MRD-positive CR patients, MRD-positive PR patients, and MRD-indeterminate patients 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
OS in MRD-negative PR patients, MRD-positive CR patients, MRD-positive PR patients, and MRD-indeterminate patients who undergo auto-HCT followed by rituximab
Time between randomization and death from any cause, assessed up to 10 years
Rate of complications in MCL patients undergoing maintenance rituximab
Up to 10 years
MRD status in MCL patients who were MRD-positive prior to auto-HCT
At 100 days after HCT
- +1 more secondary outcomes
Study Arms (2)
Group I (auto-HCT, rituximab)
EXPERIMENTALPatients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 100-140 days after transplant, patients receive rituximab IV or rituximab and hyaluronidase human SC or any approved rituximab biosimilar at the approved dose once every 8 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo PET, CT or PET/CT throughout the study. Patients may undergo blood sample collection during screening and on study. Patients also may undergo bone marrow biopsy and aspirate during screening.
Group II (rituximab)
EXPERIMENTALPatients receive standard of care induction chemotherapy. Beginning 40-180 days after completion of chemotherapy, patients receive rituximab or rituximab and hyaluronidase human or any approved rituximab biosimilar at the approved dose, as in Group I. Patients undergo PET, CT or PET/CT throughout the study. Patients may undergo blood sample collection during screening and on study. Patients also may undergo bone marrow biopsy and aspirate during screening.
Interventions
Undergo bone marrow biopsy and aspirate
Undergo bone marrow biopsy and aspirate
Undergo CT or PET/CT
Given IV
Given SC
Undergo blood sample collection
Undergo PET or PET/CT
Undergo HCT
Eligibility Criteria
You may qualify if:
- Age \>= 18 and =\< 70 years
- Patients must have histologically confirmed mantle cell lymphoma, with cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (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
- In the opinion of the enrolling physician, patients must be felt to be a candidate for autologous stem cell transplantation
- Patient may be about to begin, be receiving or have completed induction therapy within 120 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 and have been restaged, restaging evaluation must show status of partial (PR) or complete response (CR); post-induction patients with evidence of clinical disease progression are not eligible for preregistration
- Up to two regimens of therapy (conventional chemotherapy, antibody therapy, or an oral regimen) are allowed as long as a continuous response was ongoing throughout therapy; overall, a partial response needs to have been achieved (using studies at the time of diagnosis as the baseline)
- 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: If adequate tumor tissue is not available, peripheral blood collected prior to start of treatment with high disease burden (\> 5%) is acceptable for molecular marker identification (ID) testing
- Adaptive Biotechnologies will forward results within fourteen (14) days of receipt of any stored (e.g. frozen or FFPE) tumor tissue specimen to the submitting institution and to the ECOG-American College of Radiology Imaging Network (ACRIN) Operations Office
- 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
- Adaptive Biotechnologies will forward results within ten to fourteen (10-14) days of receipt of fresh peripheral blood specimen to the submitting institution and to the ECOG-ACRIN Operations Office
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ECOG-ACRIN Cancer Research Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (375)
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233, United States
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska, 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska, 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska, 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska, 99508, United States
Katmai Oncology Group
Anchorage, Alaska, 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska, 99508, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
Kingman Regional Medical Center
Kingman, Arizona, 86401, United States
University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704, United States
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
City of Hope Comprehensive Cancer Center
Duarte, California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
UC San Diego Medical Center - Hillcrest
San Diego, California, 92103, United States
UCSF Medical Center-Parnassus
San Francisco, California, 94143, United States
BASS Medical Group - Lennon
Walnut Creek, California, 94598, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Boulder Community Foothills Hospital
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado, 80112, United States
Cancer Center of Colorado at Sloan's Lake
Denver, Colorado, 80204, United States
Denver Health Medical Center
Denver, Colorado, 80204, United States
National Jewish Health-Main Campus
Denver, Colorado, 80206, United States
The Women's Imaging Center
Denver, Colorado, 80209, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado, 80113, United States
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, 80113, United States
National Jewish Health-Western Hematology Oncology
Golden, Colorado, 80401, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501, United States
Grand Valley Oncology
Grand Junction, Colorado, 81505, United States
Banner North Colorado Medical Center
Greeley, Colorado, 80631, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, 80111, United States
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette, Colorado, 80026, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501, United States
Banner McKee Medical Center
Loveland, Colorado, 80539, United States
National Jewish Health-Northern Hematology Oncology
Thornton, Colorado, 80260, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260, United States
Intermountain Health Lutheran Hospital
Wheat Ridge, Colorado, 80401, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790, United States
University of Florida Health Science Center - Gainesville
Gainesville, Florida, 32610, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Memorial Hospital West
Pembroke Pines, Florida, 33028, United States
Moffitt Cancer Center-International Plaza
Tampa, Florida, 33607, United States
Moffitt Cancer Center - McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho, 83605, United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho, 83814, United States
Walter Knox Memorial Hospital
Emmett, Idaho, 83617, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Idaho Urologic Institute-Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83686, United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho, 83687, United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho, 83854, United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho, 83864, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, 60527, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois, 60134, United States
Loyola Medicine Homer Glen
Homer Glen, Illinois, 60491, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois, 60045, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois, 60160, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, 60462, United States
Memorial Hospital East
Shiloh, Illinois, 62269, United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois, 60555, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, 66502, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky, 40202, United States
UofL Health Medical Center Northeast
Louisville, Kentucky, 40245, United States
Mercy Health - Paducah Cancer Center
Paducah, Kentucky, 42003, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Huron Medical Center PC
Port Huron, Michigan, 48060, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Community Hospital of Anaconda
Anaconda, Montana, 59711, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Community Medical Center
Missoula, Montana, 59804, United States
Nebraska Medicine-Bellevue
Bellevue, Nebraska, 68123, United States
Nebraska Medicine-Village Pointe
Omaha, Nebraska, 68118, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, 89703, United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074, United States
GenesisCare USA - Henderson
Henderson, Nevada, 89074, United States
Las Vegas Urology - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pebble
Henderson, Nevada, 89074, United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074, United States
Las Vegas Urology - Pecos
Las Vegas, Nevada, 89074, United States
Desert West Surgery
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103, United States
Cancer and Blood Specialists-Shadow
Las Vegas, Nevada, 89106, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada, 89106, United States
GenesisCare USA - Las Vegas
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113, United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada, 89113, United States
Las Vegas Urology - Sunset
Las Vegas, Nevada, 89113, United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89113, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128, United States
Cancer and Blood Specialists-Tenaya
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada, 89128, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada, 89128, United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada, 89128, United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128, United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
GenesisCare USA - Fort Apache
Las Vegas, Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
University Cancer Center
Las Vegas, Nevada, 89169, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Radiation Oncology Associates
Reno, Nevada, 89509, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Glens Falls Hospital
Glens Falls, New York, 12801, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester
Rochester, New York, 14642, United States
Wilmot Cancer Institute at Webster
Webster, New York, 14580, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Atrium Health Pineville/LCI-Pineville
Charlotte, North Carolina, 28210, United States
Wake Forest University at Clemmons
Clemmons, North Carolina, 27012, United States
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Novant Health Cancer Institute - Huntersville
Huntersville, North Carolina, 28078, United States
Novant Health Presbyterian Medical Center Huntersville
Huntersville, North Carolina, 28078, United States
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, 27284, United States
Matthews Radiation Oncology Center
Matthews, North Carolina, 28105, United States
Novant Health Cancer Institute - Matthews
Matthews, North Carolina, 28105, United States
Novant Health Cancer Institute - Mooresville
Mooresville, North Carolina, 28117, United States
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, 27030, United States
Novant Health Cancer Institute - Wilkesboro
North Wilkesboro, North Carolina, 28659, United States
Rowan Regional Medical Center
Salisbury, North Carolina, 28144, United States
Novant Health Cancer Institute - Statesville
Stateville, North Carolina, 28625, United States
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, 27360, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Premier Blood and Cancer Center
Dayton, Ohio, 45409, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio, 45331, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Saint Alphonsus Cancer Care Center-Baker City
Baker City, Oregon, 97814, United States
Saint Charles Health System
Bend, Oregon, 97701, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015, United States
Bay Area Hospital
Coos Bay, Oregon, 97420, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon, 97914, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Saint Charles Health System-Redmond
Redmond, Oregon, 97756, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, 15601, United States
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232, United States
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, 15237, United States
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, 15243, United States
UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania, 15401, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Prisma Health Cancer Institute - Laurens
Clinton, South Carolina, 29325, United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Methodist Willowbrook Hospital
Houston, Texas, 77070, United States
Houston Methodist Sugar Land Hospital
Sugar Land, Texas, 77479, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Farmington Health Center
Farmington, Utah, 84025, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Riverton Hospital
Riverton, Utah, 84065, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
South Jordan Health Center
South Jordan, Utah, 84009, United States
Saint George Regional Medical Center
St. George, Utah, 84770, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington, 98520, United States
MultiCare Auburn Medical Center
Auburn, Washington, 98001, United States
Overlake Medical Center
Bellevue, Washington, 98004, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531, United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington, 98026, United States
Providence Regional Cancer Partnership
Everett, Washington, 98201, United States
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, 98335, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, 98503, United States
PeaceHealth Saint John Medical Center
Longview, Washington, 98632, United States
Skagit Regional Health Cancer Care Center
Mount Vernon, Washington, 98274, United States
Jefferson Healthcare
Port Townsend, Washington, 98368, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372, United States
Valley Medical Center
Renton, Washington, 98055, United States
Pacific Gynecology Specialists
Seattle, Washington, 98104, United States
Swedish Medical Center-Ballard Campus
Seattle, Washington, 98107, United States
FHCC South Lake Union
Seattle, Washington, 98109, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Kaiser Permanente Washington
Seattle, Washington, 98112, United States
Swedish Medical Center-Cherry Hill
Seattle, Washington, 98122-5711, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284, United States
Providence Regional Cancer System-Shelton
Shelton, Washington, 98584, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane, Washington, 99204, United States
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane, Washington, 99218, United States
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley, Washington, 99216, United States
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Providence Regional Cancer System-Yelm
Yelm, Washington, 98597, United States
United Hospital Center
Bridgeport, West Virginia, 26330, United States
WVUH-Berkely Medical Center
Martinsburg, West Virginia, 25401, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Camden Clark Medical Center
Parkersburg, West Virginia, 26101, United States
Wheeling Hospital/Schiffler Cancer Center
Wheeling, West Virginia, 26003, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Marshfield Medical Center - Ladysmith
Ladysmith, Wisconsin, 54848, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Froedtert and MCW Moorland Reserve Health Center
New Berlin, Wisconsin, 53151, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, 54482, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001, United States
Billings Clinic-Cody
Cody, Wyoming, 82414, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
King Faisal Specialist Hospital and Research Centre
Riyadh, 11211, Saudi Arabia
Related Publications (2)
Kumar A. What is the role of up-front autologous stem cell transplantation in mantle cell lymphoma? Hematology Am Soc Hematol Educ Program. 2022 Dec 9;2022(1):155-162. doi: 10.1182/hematology.2022000333.
PMID: 36485104DERIVEDThiruvengadam SK, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.
PMID: 33288485DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy S Fenske
ECOG-ACRIN Cancer Research Group
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2017
First Posted
August 30, 2017
Study Start
November 27, 2017
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
January 31, 2027
Last Updated
July 17, 2026
Record last verified: 2026-07