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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

Trial Status: Active

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. 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.

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 fluorescence in situ hybridization (FISH); 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 seven (7) days of receipt of fresh peripheral blood specimen to the submitting institution and to the ECOG-ACRIN Operations Office
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patients must have met eligibility criteria for the screening step 0
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): The proliferation rate, using Ki-67 or MIB-1 immunohistochemistry (=< 30% versus > 30% versus “indeterminate” Ki-67 index), must be documented for a baseline tumor biopsy specimen
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): 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
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patients must have completed induction therapy within 150 days prior to registration to step 1, 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 therapy (conventional chemotherapy, antibody therapy, or an oral regimen) 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
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patients must have achieved a radiologic complete or partial remission as defined by the Lugano criteria
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): In the opinion of the enrolling physician, patients must be felt to be a candidate for autologous stem cell transplantation
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): 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 that has minimal overlapping toxicity and pharmacokinetic interactions with protocol therapy * No history of HIV-related opportunistic disease or acquired immune deficiency syndrome (AIDS)-defining conditions within past 12 months other than historic CD4+ T-cell counts below 200 cells/mm^3 * Expected long-term survival if lymphoma were not present
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): 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, melanoma in situ post wide local excision or Mohs surgery, low grade prostate carcinoma (Gleason grade =< 6) managed with observation that has been stable for at least 6 months
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): Women must not be pregnant or breast-feeding due to the potential for congenital abnormalities and of harm to nursing infants due to the treatment regimens used * 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)
  • INCLUSION CRITERIA FOR TREATMENT ASSIGNMENT (STEP 1): 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 and for 12 months post rituximab treatment

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 205-934-0220

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
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Phone: 907-212-6871
Alaska Oncology and Hematology LLC
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Alaska Women's Cancer Care
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Anchorage Associates in Radiation Medicine
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Anchorage Oncology Centre
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Anchorage Radiation Therapy Center
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Katmai Oncology Group
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Providence Alaska Medical Center
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Fairbanks Memorial Hospital
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Arizona

Kingman
Kingman Regional Medical Center
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Tucson
Banner University Medical Center - Tucson
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University of Arizona Cancer Center-North Campus
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University of Arizona Cancer Center-Orange Grove Campus
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Phone: 520-694-8900

California

Arroyo Grande
PCR Oncology
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Phone: 702-384-0013
Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
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Contact: Site Public Contact
Phone: 818-847-4793
Duarte
City of Hope Comprehensive Cancer Center
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Phone: 800-826-4673
La Jolla
UC San Diego Moores Cancer Center
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Phone: 858-822-5354
San Francisco
UCSF Medical Center-Parnassus
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Colorado

Aurora
Rocky Mountain Cancer Centers-Aurora
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Phone: 303-777-2663
The Medical Center of Aurora
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Boulder
Boulder Community Hospital
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Rocky Mountain Cancer Centers-Boulder
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Phone: 303-777-2663
Denver
Cancer Center of Colorado at Sloan's Lake
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Phone: 303-777-2663
Colorado Blood Cancer Institute
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Denver Health Medical Center
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Phone: 303-777-2663
National Jewish Health-Main Campus
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Phone: 877-225-5654
Presbyterian - Saint Lukes Medical Center - Health One
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Phone: 303-777-2663
Rocky Mountain Cancer Centers-Midtown
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Rocky Mountain Cancer Centers-Rose
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Phone: 303-777-2663
Rose Medical Center
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Phone: 303-777-2663
SCL Health Saint Joseph Hospital
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Phone: 303-777-2663
The Women's Imaging Center
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Phone: 303-777-2663
Englewood
Mountain Blue Cancer Care Center - Swedish
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Phone: 303-777-2663
Swedish Medical Center
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Phone: 303-777-2663
Golden
National Jewish Health-Western Hematology Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
Grand Junction
Grand Valley Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 970-644-4460
Saint Mary's Hospital and Regional Medical Center
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Phone: 303-777-2663
Greeley
North Colorado Medical Center
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Phone: 303-777-2663
Greenwood Village
Rocky Mountain Cancer Centers-Greenwood Village
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 303-777-2663
Lafayette
Good Samaritan Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-673-1622
Littleton
Rocky Mountain Cancer Centers-Littleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Sky Ridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Loveland
McKee Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Thornton
National Jewish Health-Northern Hematology Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Wheat Ridge
SCL Health Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663

Connecticut

Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702
New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702
Yale University
Status: ACTIVE
Contact: Site Public Contact
Phone: 203-785-5702

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: ACTIVE
Contact: Site Public Contact
Phone: 352-273-8010
Jacksonville
Baptist MD Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 904-202-7468
Mayo Clinic in Florida
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 305-243-2647
Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-679-0775

Georgia

Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Augusta
Augusta University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 706-721-2388

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Coeur D'Alene
Kootenai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Emmett
Walter Knox Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Meridian
Idaho Urologic Institute-Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Luke's Mountain States Tumor Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Post Falls
Kootenai Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Sandpoint
Kootenai Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059

Illinois

Burr Ridge
Loyola Center for Health at Burr Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-216-9000
Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-695-1301
Rush University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-942-5498
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-315-1918
Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-315-1918
Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: ACTIVE
Contact: Site Public Contact
Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-226-4357
Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-450-4554
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Orland Park
Loyola Center for Cancer Care and Research
Status: ACTIVE
Contact: Site Public Contact
Phone: 708-216-9000
University of Chicago Medicine-Orland Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 773-702-8222
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Phone: 630-315-1918

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632
Sidney and Lois Eskenazi Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 317-278-5632

Kansas

Chanute
Cancer Center of Kansas - Chanute
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Dodge City
Cancer Center of Kansas - Dodge City
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
El Dorado
Cancer Center of Kansas - El Dorado
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Fort Scott
Cancer Center of Kansas - Fort Scott
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Independence
Cancer Center of Kansas-Independence
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Kingman
Cancer Center of Kansas-Kingman
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Lawrence
Lawrence Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Liberal
Cancer Center of Kansas-Liberal
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Manhattan
Cancer Center of Kansas-Manhattan
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5784
McPherson
Cancer Center of Kansas - McPherson
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Newton
Cancer Center of Kansas - Newton
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Parsons
Cancer Center of Kansas - Parsons
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Pratt
Cancer Center of Kansas - Pratt
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Salina
Cancer Center of Kansas - Salina
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Wellington
Cancer Center of Kansas - Wellington
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 913-945-7552
Wichita
Ascension Via Christi Hospitals Wichita
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-362-0070
Associates In Womens Health
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas - Wichita
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374
Winfield
Cancer Center of Kansas - Winfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 316-268-5374

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 859-257-3379
Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: ACTIVE
Contact: Site Public Contact
Phone: 502-562-3429

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 410-955-8804

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 617-667-9925
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-726-5130

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-865-1125
Port Huron
Huron Medical Center PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013
Lake Huron Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 702-384-0013

Minnesota

Rochester
Mayo Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 855-776-0015

Missouri

Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Louis
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606

Montana

Anaconda
Community Hospital of Anaconda
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Saint Vincent Frontier Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-648-6274
Saint Vincent Healthcare
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Butte
Saint James Community Hospital and Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-723-2621
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Helena
Saint Peter's Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 406-969-6060
Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060
Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-327-3118

Nebraska

Bellevue
Nebraska Medicine-Bellevue
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941
Omaha
Nebraska Medicine-Village Pointe
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-5600
University of Nebraska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 402-559-6941

Nevada

Carson City
Carson Tahoe Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Henderson
21st Century Oncology-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Henderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Urology - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Pebble
Status: ACTIVE
Contact: Site Public Contact
OptumCare Cancer Care at Seven Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Urology Specialists of Nevada - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Las Vegas
21st Century Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
21st Century Oncology-Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
21st Century Oncology-Vegas Tenaya
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Ann M Wierman MD LTD
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Shadow
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Cancer and Blood Specialists-Tenaya
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Central Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada - Town Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Comprehensive Cancer Centers of Nevada-Summerlin
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Desert West Surgery
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Centennial Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Maryland Parkway
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-San Martin
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
HealthCare Partners Medical Group Oncology / Hematology-Tenaya
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Hope Cancer Care of Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Cancer Center-Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Las Vegas Prostate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Cathedral Rock
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Pecos
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Smoke Ranch
Status: ACTIVE
Contact: Site Public Contact
Las Vegas Urology - Sunset
Status: ACTIVE
Contact: Site Public Contact
OptumCare Cancer Care at Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at MountainView
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
OptumCare Cancer Care at Oakey
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Central
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Radiation Oncology Centers of Nevada Southeast
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Summerlin Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Sunrise Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
University Medical Center of Southern Nevada
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Urology Specialists of Nevada - Central
Status: ACTIVE
Contact: Site Public Contact
Urology Specialists of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Urology Specialists of Nevada - Southwest
Status: ACTIVE
Contact: Site Public Contact
Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Reno
Radiation Oncology Associates
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013
Saint Mary's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 702-384-0013

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-639-6918

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact
Phone: 732-235-8675

New York

Buffalo
Roswell Park Cancer Institute
Status: APPROVED
Contact: Site Public Contact
Phone: 800-767-9355
Glens Falls
Glens Falls Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 518-926-6700
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 212-639-7592
Rochester
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-668-0683
Charlotte
Atrium Health Pineville / LCI-Pineville
Status: ACTIVE
Contact: Site Public Contact
Phone: 980-442-2000
Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-9376
Clemmons
Wake Forest University at Clemmons
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-716-9259
Durham
Duke University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-275-3853
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

Ohio

Cleveland
Case Western Reserve University
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-641-2422
Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Phone: 866-223-8100
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Bend
Saint Charles Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909
Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Cancer Institute Clackamas Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Coos Bay
Bay Area Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-269-8392
Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Ontario
Saint Alphonsus Medical Center-Ontario
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Portland
Oregon Health and Science University
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-494-1080
Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-215-2614
Redmond
Saint Charles Health System-Redmond
Status: ACTIVE
Contact: Site Public Contact
Phone: 541-706-2909

Pennsylvania

Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-474-9892
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-8073

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-792-9321
Clinton
Prisma Health Cancer Institute - Laurens
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Easley
Prisma Health Cancer Institute - Easley
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Greenville
Prisma Health Cancer Institute - Butternut
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Greenville Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Saint Francis Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Greer
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-811-8480

Texas

Houston
Houston Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 713-790-2700
Methodist Willowbrook Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Sugar Land
Houston Methodist Sugar Land Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 281-242-2873

Utah

American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-855-4100
Cedar City
Sandra L Maxwell Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 435-868-5680
Farmington
Farmington Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100
Logan
Logan Regional Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 435-716-6400
Murray
Intermountain Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-507-3950
Ogden
McKay-Dee Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-387-7426
Provo
Utah Valley Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-357-7965
Riverton
Riverton Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-507-3950
Saint George
Dixie Medical Center Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 435-688-4167
Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100
LDS Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-408-1347
Utah Cancer Specialists-Salt Lake City
Status: ACTIVE
Contact: Site Public Contact
Phone: 801-933-6070
South Jordan
South Jordan Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-424-2100

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu
University of Vermont and State Agricultural College
Status: ACTIVE
Contact: Site Public Contact
Phone: 802-656-8990
Email: rpo@uvm.edu

Virginia

Charlottesville
University of Virginia Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 434-243-6303

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Auburn
MultiCare Auburn Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-887-9333
Bellevue
Overlake Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-688-5407
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-715-4133
Centralia
Providence Regional Cancer System-Centralia
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Edmonds
Swedish Cancer Institute-Edmonds
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Everett
Providence Regional Cancer Partnership
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-261-3529
Gig Harbor
MultiCare Gig Harbor Medical Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-403-2394
Issaquah
Swedish Cancer Institute-Issaquah
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Kennewick
Kadlec Clinic Hematology and Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-783-4637
Lacey
Providence Regional Cancer System-Lacey
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Longview
PeaceHealth Saint John Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-2016
Port Townsend
Jefferson Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-344-3091
Puyallup
MultiCare Good Samaritan Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-351-7955
Renton
Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 425-228-3440
Seattle
Fred Hutchinson Cancer Research Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-8824
Kaiser Permanente Washington
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 206-215-3086
Pacific Gynecology Specialists
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Seattle Cancer Care Alliance
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-8824
Swedish Medical Center-Ballard Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-Cherry Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
Swedish Medical Center-First Hill
Status: ACTIVE
Contact: Site Public Contact
Phone: 206-215-3086
University of Washington Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-804-8824
Sedro-Woolley
PeaceHealth United General Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-788-8240
Shelton
Providence Regional Cancer System-Shelton
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-7249
MultiCare Deaconess Cancer and Blood Specialty Center - North
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-402-7249
Spokane Valley
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-403-7249
Tacoma
Mary Bridge Children's Hospital and Health Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 253-403-1461
MultiCare Tacoma General Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 253-403-3229
Vancouver
PeaceHealth Southwest Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-514-3940
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 509-897-5993
Yelm
Providence Regional Cancer System-Yelm
Status: ACTIVE
Contact: Site Public Contact
Phone: 360-412-8958

West Virginia

Bridgeport
United Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374
Martinsburg
WVUH-Berkely Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374
Morgantown
West Virginia University Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374
Parkersburg
Camden Clark Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-293-7374

Wisconsin

Chippewa Falls
Marshfield Clinic-Chippewa Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Mayo Clinic Health System-Eau Claire Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 855-776-0015
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
Ladysmith
Marshfield Clinic - Ladysmith Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Madison
University of Wisconsin Hospital and Clinics
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-622-8922
Marshfield
Marshfield Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-782-8581
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Milwaukee
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-805-3666
Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Mukwonago
ProHealth D N Greenwald Center
Status: ACTIVE
Contact: Site Public Contact
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7878
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Stevens Point
Marshfield Clinic Stevens Point Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Waukesha
ProHealth Waukesha Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-7632
UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Phone: 262-928-5539
Wausau
Marshfield Clinic-Wausau Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Weston
Marshfield Clinic - Weston Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581

Wyoming

Cheyenne
Cheyenne Regional Medical Center-West
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-777-2663
Cody
Billings Clinic-Cody
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-996-2663
Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

II. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive CR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

III. To define the overall survival and progression-free survival at 2 and 5 years of chemosensitive but MRD-positive partial response (PR) patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

IV. To define the overall survival and progression-free survival at 2 and 5 years of MRD-negative PR patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

V. To define the overall survival and progression-free survival at 2 and 5 years of MRD-indeterminate patients who undergo auto-HCT followed by 3 years of maintenance rituximab.

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

VII. To determine the prognostic impact of MRD status at day 100, in MCL patients who were MRD-positive (including MRD-positive CR and MRD-positive PR) prior to auto-HCT.

EXPLORATORY TOBACCO USE OBJECTIVES:

I. To determine the effects of tobacco, operationalized as combustible tobacco (1a), other forms of tobacco (1b), and environmental tobacco exposure (ETS) (1c) on provider-reported cancer-treatment toxicity (adverse events (both clinical and hematologic) and dose modifications).

II. To determine the effects of tobacco on patient-reported physical symptoms and psychological symptoms.

III. To examine quitting behaviors and behavioral counseling/support and cessation medication utilization.

IV. To explore the effect of tobacco use and exposure on treatment duration, relative dose intensity, and therapeutic benefit.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive standard of care preparative chemotherapy and undergo auto-HCT. Beginning 100-140 days after transplant, patients receive rituximab intravenously (IV) or rituximab and hyaluronidase human subcutaneously (SC) once every 8 weeks for up to 18 cycles in the absence of disease progression or unacceptable toxicity.

GROUP II: Patients receive standard of care induction chemotherapy. Beginning 40-140 days after completion of chemotherapy, patients receive rituximab or rituximab and hyaluronidase human as in Group I.

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

Trial Phase Phase III

Trial Type Treatment

Lead Organization
ECOG-ACRIN Cancer Research Group

Principal Investigator
Timothy Sean Fenske

  • Primary ID EA4151
  • Secondary IDs NCI-2016-01403
  • Clinicaltrials.gov ID NCT03267433