Blood Cancer

EA4151



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

STATUS: Active


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.
  • 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). 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

  • 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): Patient 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 patients of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy * A patient of childbearing potential is anyone, 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): Patient 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

  • Age >= 18 and =< 70 years

Saudi Arabia
Riyadh
King Faisal Specialist Hospital and Research Centre
Status: ACTIVE
Contact: Site Public Contact

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
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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
Fairbanks Memorial Hospital
Status: ACTIVE
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Email: Veronica.Stevenson@foundationhealth.org

AL
Birmingham
University of Alabama at Birmingham Cancer Center
Status: ACTIVE
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Email: tmyrick@uab.edu

AZ
Kingman
Kingman Regional Medical Center
Status: ACTIVE
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Email: research@sncrf.org

Tucson
Banner University Medical Center - Tucson
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Email: UACC-NCTN@uacc.arizona.edu

University of Arizona Cancer Center-North Campus
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University of Arizona Cancer Center-Orange Grove Campus
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CA
Arroyo Grande
PCR Oncology
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Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
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Email: Najee.Boucher@providence.org

Duarte
City of Hope Comprehensive Cancer Center
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La Jolla
UC San Diego Moores Cancer Center
Status: ACTIVE
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Email: cancercto@ucsd.edu

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
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Email: ucstudy@uci.edu

San Diego
UC San Diego Medical Center - Hillcrest
Status: ACTIVE
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Email: rhabbaba@health.ucsd.edu

San Francisco
UCSF Medical Center-Parnassus
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CO
Aurora
Rocky Mountain Cancer Centers-Aurora
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Email: info@westernstatesncorp.org

The Medical Center of Aurora
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Boulder
Boulder Community Foothills Hospital
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Boulder Community Hospital
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Email: jbloomfield@co-cancerresearch.org

Rocky Mountain Cancer Centers-Boulder
Status: ACTIVE
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Centennial
Rocky Mountain Cancer Centers - Centennial
Status: ACTIVE
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Denver
Cancer Center of Colorado at Sloan's Lake
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Colorado Blood Cancer Institute
Status: ACTIVE
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Email: info@westernstatesncorp.org

Denver Health Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Email: ccrp@co-cancerresearch.org

National Jewish Health-Main Campus
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
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Email: glicht@co-cancerresearch.org

Presbyterian - Saint Lukes Medical Center - Health One
Status: ACTIVE
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Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Midtown
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Rocky Mountain Cancer Centers-Rose
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Rose Medical Center
Status: ACTIVE
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Email: ccrp@co-cancerresearch.org

SCL Health Saint Joseph Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: alan.franklin@sclhealth.org

The Women's Imaging Center
Status: ACTIVE
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Email: info@westernstatesncorp.org

Englewood
Mountain Blue Cancer Care Center - Swedish
Status: ACTIVE
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Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers - Swedish
Status: ACTIVE
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Email: info@westernstatesncorp.org

Swedish Medical Center
Status: ACTIVE
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Email: info@westernstatesncorp.org

The Melanoma and Skin Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: ryan.weight@theskincancerinstitute.com

Golden
National Jewish Health-Western Hematology Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: glicht@co-cancerresearch.org

Grand Junction
Grand Valley Oncology
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: gvoclinicaltrials@gjhosp.org

Saint Mary's Hospital and Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

Greeley
North Colorado Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Greenwood Village
Rocky Mountain Cancer Centers-Greenwood Village
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Lafayette
Good Samaritan Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Lakewood
Rocky Mountain Cancer Centers-Lakewood
Status: ACTIVE
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Email: info@westernstatesncorp.org

Littleton
Rocky Mountain Cancer Centers-Littleton
Status: ACTIVE
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Email: info@westernstatesncorp.org

Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Sky Ridge Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Loveland
McKee Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Thornton
National Jewish Health-Northern Hematology Oncology
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: glicht@co-cancerresearch.org

Rocky Mountain Cancer Centers-Thornton
Status: ACTIVE
Contact: Site Public Contact
Email: info@westernstatesncorp.org

Wheat Ridge
SCL Health Lutheran Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

CT
Hartford
Smilow Cancer Hospital Care Center at Saint Francis
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswers@yale.edu

New Haven
Smilow Cancer Center / Yale-New Haven Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswers@yale.edu

Yale University
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswers@yale.edu

Torrington
Smilow Cancer Hospital-Torrington Care Center
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswers@yale.edu

FL
Gainesville
University of Florida Health Science Center - Gainesville
Status: ACTIVE
Contact: Site Public Contact
Email: cancer-center@ufl.edu

Hollywood
Memorial Regional Hospital / Joe DiMaggio Children's Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: OHR@mhs.net

Jacksonville
Baptist MD Anderson Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Mayo Clinic in Florida
Status: ACTIVE
Contact: Site Public Contact

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Pembroke Pines
Memorial Hospital West
Status: ACTIVE
Contact: Site Public Contact

Tampa
Moffitt Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org

Moffitt Cancer Center - McKinley Campus
Status: ACTIVE
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org

Moffitt Cancer Center-International Plaza
Status: ACTIVE
Contact: Site Public Contact
Email: ClinicalTrials@moffitt.org

GA
Atlanta
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact

Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
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Augusta
Augusta University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ga_cares@augusta.edu

ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Emmett
Walter Knox Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Idaho Urologic Institute-Meridian
Status: ACTIVE
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Nampa
Saint Alphonsus Medical Center-Nampa
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Email: eslinget@slhs.org

IL
Burr Ridge
Loyola Center for Health at Burr Ridge
Status: ACTIVE
Contact: Site Public Contact

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancer@northwestern.edu

Rush University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: clinical_trials@rush.edu

University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Geneva
Northwestern Medicine Cancer Center Delnor
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

Homer Glen
Loyola Medicine Homer Glen
Status: ACTIVE
Contact: Site Public Contact

Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancertrials@northwestern.edu

Maywood
Loyola University Medical Center
Status: ACTIVE
Contact: Site Public Contact

Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Status: ACTIVE
Contact: Site Public Contact

New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

Orland Park
University of Chicago Medicine-Orland Park
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: ACTIVE
Contact: Site Public Contact
Email: Donald.Smith3@nm.org

IN
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: iutrials@iu.edu

Sidney and Lois Eskenazi Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: iutrials@iu.edu

KS
Chanute
Cancer Center of Kansas - Chanute
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Dodge City
Cancer Center of Kansas - Dodge City
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

El Dorado
Cancer Center of Kansas - El Dorado
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Fort Scott
Cancer Center of Kansas - Fort Scott
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Independence
Cancer Center of Kansas-Independence
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Kingman
Cancer Center of Kansas-Kingman
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Lawrence
Lawrence Memorial Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Stephanie.Norris@LMH.ORG

Liberal
Cancer Center of Kansas-Liberal
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Manhattan
Cancer Center of Kansas-Manhattan
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

McPherson
Cancer Center of Kansas - McPherson
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Newton
Cancer Center of Kansas - Newton
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Parsons
Cancer Center of Kansas - Parsons
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Pratt
Cancer Center of Kansas - Pratt
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Salina
Cancer Center of Kansas - Salina
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Wellington
Cancer Center of Kansas - Wellington
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Wichita
Ascension Via Christi Hospitals Wichita
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Associates In Womens Health
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Cancer Center of Kansas - Wichita
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Cancer Center of Kansas-Wichita Medical Arts Tower
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

Winfield
Cancer Center of Kansas - Winfield
Status: ACTIVE
Contact: Site Public Contact
Email: Keisha.humphries@ascension.org

KY
Lexington
University of Kentucky / Markey Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Louisville
The James Graham Brown Cancer Center at University of Louisville
Status: ACTIVE
Contact: Site Public Contact

MA
Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Contact: Site Public Contact

Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Site Public Contact

Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact

MD
Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: jhcccro@jhmi.edu

MI
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Farmington Hills
Weisberg Cancer Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Port Huron
Huron Medical Center PC
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Lake Huron Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

MN
Rochester
Mayo Clinic in Rochester
Status: ACTIVE
Contact: Site Public Contact

MO
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Louis
SSM Health Saint Louis University Hospital
Status: ACTIVE
Contact: Site Public Contact

Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: info@siteman.wustl.edu

MT
Anaconda
Community Hospital of Anaconda
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@billingsclinic.org

Saint Vincent Frontier Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Saint Vincent Healthcare
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Butte
Saint James Community Hospital and Cancer Treatment Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Helena
Saint Peter's Community Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: amy.hanneman@providence.org

NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

Charlotte
Atrium Health Pineville / LCI-Pineville
Status: ACTIVE
Contact: Site Public Contact

Carolinas Medical Center / Levine Cancer Institute
Status: ACTIVE
Contact: Site Public Contact

Clemmons
Wake Forest University at Clemmons
Status: ACTIVE
Contact: Site Public Contact

Concord
Atrium Health Cabarrus / LCI-Concord
Status: ACTIVE
Contact: Site Public Contact

Durham
Duke University Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact

NE
Bellevue
Nebraska Medicine-Bellevue
Status: ACTIVE
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

Omaha
Nebraska Medicine-Village Pointe
Status: ACTIVE
Contact: Site Public Contact

University of Nebraska Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: unmcrsa@unmc.edu

NH
Lebanon
Dartmouth Hitchcock Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancer.research.nurse@dartmouth.edu

NJ
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Site Public Contact

NV
Carson City
Carson Tahoe Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Henderson
Cancer and Blood Specialists-Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Henderson
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pebble
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Seven Hills
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Green Valley
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas
Alliance for Childhood Diseases / Cure 4 the Kids Foundation
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Ann M Wierman MD LTD
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Cancer and Blood Specialists-Shadow
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Cancer and Blood Specialists-Tenaya
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Desert West Surgery
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Las Vegas
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Vegas Tenaya
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-Centennial Hills
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-Maryland Parkway
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-San Martin
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology / Hematology-Tenaya
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: research@sncrf.org

Hope Cancer Care of Nevada
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Prostate Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Cathedral Rock
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pecos
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Smoke Ranch
Status: ACTIVE
Contact: Site Public Contact
Email: research@smcrf.org

Las Vegas Urology - Sunset
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Charleston
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Fort Apache
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at MountainView
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Central
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Summerlin Hospital Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Sunrise Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

University Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

University Medical Center of Southern Nevada
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Central
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Northwest
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Southwest
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Pahrump
Hope Cancer Care of Nevada-Pahrump
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Reno
Radiation Oncology Associates
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Renown Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

Saint Mary's Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: research@sncrf.org

NY
Buffalo
Roswell Park Cancer Institute
Status: WITHDRAWN
Contact: Site Public Contact
Email: askroswell@roswellpark.org

Glens Falls
Glens Falls Hospital
Status: ACTIVE
Contact: Site Public Contact

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Rochester
University of Rochester
Status: ACTIVE
Contact: Site Public Contact

OH
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancer@uchealth.com

Cleveland
Case Western Reserve University
Status: ACTIVE
Contact: Site Public Contact
Email: CTUReferral@UHhospitals.org

Cleveland Clinic Foundation
Status: ACTIVE
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Jamesline@osumc.edu

West Chester
University of Cincinnati Cancer Center-West Chester
Status: ACTIVE
Contact: Site Public Contact
Email: cancer@uchealth.com

OK
Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Baker City
Saint Alphonsus Medical Center-Baker City
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bend
Saint Charles Health System
Status: ACTIVE
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Ontario
Saint Alphonsus Medical Center-Ontario
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Portland
Oregon Health and Science University
Status: ACTIVE
Contact: Site Public Contact
Email: trials@ohsu.edu

Providence Portland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Status: ACTIVE
Contact: Site Public Contact

PA
Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: HemonCCTrials@geisinger.edu

Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Status: ACTIVE
Contact: Site Public Contact

Monroeville
UPMC Hillman Cancer Center - Monroeville
Status: ACTIVE
Contact: Site Public Contact
Email: haneydl@upmc.edu

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Pittsburgh
UPMC-Passavant Hospital
Status: ACTIVE
Contact: Site Public Contact

UPMC-Saint Clair Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact

University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE
Contact: Site Public Contact

Uniontown
UPMC Cancer Center-Uniontown
Status: ACTIVE
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Status: ACTIVE
Contact: Site Public Contact

Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

Clinton
Prisma Health Cancer Institute - Laurens
Status: ACTIVE
Contact: Site Public Contact

Easley
Prisma Health Cancer Institute - Easley
Status: ACTIVE
Contact: Site Public Contact
Email: Kim.Williams3@prismahealth.org

Greenville
Prisma Health Cancer Institute - Butternut
Status: ACTIVE
Contact: Site Public Contact

Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact

Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact

Prisma Health Greenville Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact

Saint Francis Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Saint Francis Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: melissa_beckman@bshsi.org

Greer
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact

Seneca
Prisma Health Cancer Institute - Seneca
Status: ACTIVE
Contact: Site Public Contact

TN
Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE
Contact: Site Public Contact

TX
Houston
Houston Methodist Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Methodist Willowbrook Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: ctsucontact@westat.com

Sugar Land
Houston Methodist Sugar Land Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

UT
American Fork
American Fork Hospital / Huntsman Intermountain Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Cedar City
Sandra L Maxwell Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Farmington
Farmington Health Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

Logan
Logan Regional Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Murray
Intermountain Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Ogden
McKay-Dee Hospital Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Provo
Utah Valley Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Riverton
Riverton Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Saint George
Saint George Regional Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

LDS Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

Utah Cancer Specialists-Salt Lake City
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: officeofresearch@imail.org

South Jordan
South Jordan Health Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu

VA
Charlottesville
University of Virginia Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: uvacancertrials@hscmail.mcc.virginia.edu

VT
Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: ACTIVE
Contact: Site Public Contact

Burlington
University of Vermont Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: rpo@uvm.edu

University of Vermont and State Agricultural College
Status: ACTIVE
Contact: Site Public Contact
Email: rpo@uvm.edu

WI
Chippewa Falls
Marshfield Clinic-Chippewa Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Mayo Clinic Health System-Eau Claire Clinic
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org

Ladysmith
Marshfield Clinic - Ladysmith Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Madison
University of Wisconsin Carbone Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Marshfield
Marshfield Medical Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Milwaukee
Medical College of Wisconsin
Status: ACTIVE
Contact: Site Public Contact

Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Mukwonago
ProHealth D N Greenwald Center
Status: ACTIVE
Contact: Site Public Contact
Email: research.institute@phci.org

New Berlin
Froedtert and MCW Moorland Reserve Health Center
Status: ACTIVE
Contact: Site Public Contact

Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact

Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: ACTIVE
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org

Waukesha
ProHealth Waukesha Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact

UW Cancer Center at ProHealth Care
Status: ACTIVE
Contact: Site Public Contact
Email: Chanda.miller@phci.org

Wausau
Marshfield Clinic-Wausau Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Weston
Marshfield Medical Center - Weston
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

WV
Bridgeport
United Hospital Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

Martinsburg
WVUH-Berkely Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

Morgantown
West Virginia University Healthcare
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

Parkersburg
Camden Clark Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

WY
Cheyenne
Cheyenne Regional Medical Center-West
Status: ACTIVE
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

Cody
Billings Clinic-Cody
Status: ACTIVE
Contact: Site Public Contact
Email: research@billingsclinic.org

Sheridan
Welch Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

PRIMARY OBJECTIVE:
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) 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.

GROUP II: Patients 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.

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

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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