Recruiting
Phase 2

Drug Treatments

Sponsor:

SWOG Cancer Research Network

Code:

NCT05633615

Conditions

Diffuse Large B-Cell Lymphoma

Grade 3b Follicular Lymphoma

Primary Mediastinal (Thymic) Large B-Cell Lymphoma

Recurrent Diffuse Large B-Cell Lymphoma

Refractory Diffuse Large B-Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Axicabtagene Ciloleucel

Biospecimen Collection

Computed Tomography

Cyclophosphamide

Fludarabine

Study Details

Brief summary:

This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.

Conditions

Diffuse Large B-Cell Lymphoma

Grade 3b Follicular Lymphoma

Primary Mediastinal (Thymic) Large B-Cell Lymphoma

Recurrent Diffuse Large B-Cell Lymphoma

Refractory Diffuse Large B-Cell Lymphoma

Study ID

NCT05633615

Start date

Jun 12, 2023

Status verified date

Jan, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • STEP 1: REGISTRATION: Participants must have a histologically confirmed diagnosis of diffuse large B-cell lymphoma or follicular lymphoma grade 3b or primary mediastinal large B-cell lymphoma (PMBCL)
  • STEP 1: REGISTRATION: Participants with transformed DLBCL must have transformed DLBCL from follicular or marginal zone lymphoma
  • STEP 1: REGISTRATION: Participant must have bi-dimensionally measurable systemic disease (at least one lesion with longest diameter > 1.5 cm)
  • STEP 1: REGISTRATION: Participants with secondary central nervous system (CNS) lymphoma (parenchymal, spinal cord, meningeal, cerebrospinal fluid involvement) must be asymptomatic from their CNS disease
  • STEP 1: REGISTRATION: Participants must be registered for step 1 after they have signed institutional consent for CAR T-cell leukapheresis but prior to the start of lymphodepleting (LD) chemotherapy for commercial CAR T-cell product
  • STEP 1: REGISTRATION: In the opinion of the enrolling physician, participants must be felt to be a candidate for CAR T-cell therapy with plans to be treated with Food and Drug Administration (FDA) approved commercially available CD19 CAR T-cell construct.

  • Participants must qualify for commercially approved CD19 CAR T-cell therapy per FDA package insert.
  • If the CAR T-cell product does not meet parameters to be given as an FDA approved product (i.e. does not meet specification criteria mandated by FDA and is infused under an expanded access protocol \[EAP\] or single participant investigational new drug \[IND\]) the participant will be taken off of study and no longer be eligible for step 2 randomization
  • STEP 1: REGISTRATION: Participants are permitted to receive or have received 'bridging therapy' after CAR T-cell leukapheresis. However, participants must not receive polatuzumab vedotin, and/or mosunetuzumab as part of bridging therapy.

  • Bridging therapy is defined as lymphoma directed therapy administered between leukapheresis and the start of LD chemotherapy. This includes cytotoxic chemotherapy (e.g.: bendamustine and rituximab \[BR\], rituximab, gemcitabine and oxaliplatin \[R-gem/ox\]), radiation, corticosteroids, as well as novel therapies such as BTK inhibitors (e.g.: Ibrutinib), immunomodulators (e.g.: lenalidomide), monoclonal antibodies (e.g.: rituximab, obinutuzumab, tafasitamab) antibody drug conjugates (e.g: loncastuximab), checkpoint inhibitors (e.g.: pembrolizumab, nivolumab), clinical trial treatments, etc.
  • If a participant receives polatuzumab vedotin or mosunetuzumab as bridging they will ineligible to continue on step 1 registration portion of the study and be ineligible for step 2 randomization
  • STEP 1: REGISTRATION: PET-CT scan must be planned for completion within 60 days prior to the start of LD chemotherapy.

  • All pre-CAR T-cell therapy disease must be assessed and documented on the baseline/pre-registration tumor assessment form.
  • If receiving bridging therapy, participants must have a PET-CT scan upon completion of all planned bridging therapy. If the PET-CT scan after completion of bridging therapy is consistent with complete remission per Lugano criteria as determined by enrolling physician, that participant will be ineligible for step 2 randomization.
  • Participants are permitted to receive corticosteroids after leukapheresis without the need to repeat a PET-CT scan. If steroids are used, they must be planned to stop no later than 3 days before CAR -T cell infusion.
  • If response assessment by central review cannot be completed (I.e., poor quality of PET-CT scan, PET-CT performed out of window, etc.) this would be recorded as 'inadequate assessment' and patient would not be eligible for randomization
  • STEP 1: REGISTRATION: Participants that have previously been treated with polatuzumab vedotin or mosunetuzumab prior to CAR T-cell leukapheresis for either indolent or aggressive NHL are eligible as long as the participant did not have refractory disease or progression/relapse within 6 months of the last infusion with either agent
  • STEP 1: REGISTRATION: Participants must be planning to receive CAR T-cell infusion no earlier than 2 days and no later than 14 days after completion of the last day of lymphodepleting chemotherapy. Any participant receiving CAR T-cell infusion outside of this window will be ineligible for step 2 randomization
  • STEP 1: REGISTRATION: LD chemotherapy prior to CAR T-cell infusion must be planned to start within 60 days after step 1 registration
  • STEP 1: REGISTRATION: Participants must be >= 18 years of age at the time of registration
  • STEP 1: REGISTRATION: Participants must have Zubrod performance score (PS) of 0, 1, or 2
  • STEP 1: REGISTRATION: Total bilirubin =< 2 x institutional upper limit of normal (ULN) (within 14 days prior to registration)

  • Unless due to Gilbert's disease or lymphomatous involvement of liver
  • STEP 1: REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x institutional ULN (within 14 days prior to registration)
  • STEP 1: REGISTRATION: Creatinine clearance >= 40 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 14 days prior to registration. Estimated creatinine clearance is based on actual body weight
  • STEP 1: REGISTRATION: Participants must have an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 60 days prior to registration with a cardiac ejection fraction >= 40%.

  • Participants with current symptoms of cardiac disease must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better.
  • Participants must not have documented myocardial infarction and percutaneous coronary intervention (PCI) within 6 months prior to registration or myocardial infarction without PCI within 3 months of registration, or unstable angina
  • STEP 1: REGISTRATION: Participants with peripheral neuropathy must have < grade 2
  • STEP 1: REGISTRATION: Participants with hepatitis B virus infection must have undetectable viral load within 14 days prior to registration, be on suppressive therapy and have no evidence of hepatitis B virus (HBV) related hepatic damage
  • STEP 1: REGISTRATION: Participants with hepatitis C infection must have eradication therapy completed, have no evidence of hepatitis C infection (HCV) related damage and have undetectable viral load within 14 days prior to registration
  • STEP 1: REGISTRATION: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
  • STEP 1: REGISTRATION: Participants must be offered the opportunity to participate in banking for planned translational medicine and future research. With participant consent, any residuals from the mandatory tissue submission will also be banked for future research.

  • Note: Streck tubes must be ordered in advance. Please allow 5-7 days for shipment of the collection kits
  • STEP 1: REGISTRATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.

  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.

  • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
  • STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for step 1 registration
  • STEP 2: RANDOMIZATION: Participant's CAR T-cell product must have met specification parameters to be given as an FDA approved commercial product
  • STEP 2: RANDOMIZATION: Participants must have a PET-CT scan between days 25-40 after CAR T-cell infusion and determined to have a response consistent with stable disease or partial remission by central review compared to most recent pre-LD chemo/CAR T-cell PET-CT scan.

  • Note: Patients with delayed enrollment > 21 days after 'day +30' PET-CT scan will necessitate a repeat PET-CT scan if concerning signs or symptoms of lymphoma progression develop.
  • Note: If response assessment by central review cannot be completed (I.e., poor quality of PET-CT scan, PET-CT performed out of window, etc.) this would be recorded as 'inadequate assessment' and patient would not be eligible for randomization
  • STEP 2: RANDOMIZATION: Eligible participants must be randomized no later than 60 days after CAR -T infusion
  • STEP 2: RANDOMIZATION: Participants must have started LD chemotherapy within 60 days of signing consent for step 1 registration
  • STEP 2: RANDOMIZATION: Participants must have S2114 CAR T-cell therapy form submitted to Southwest Oncology Group (SWOG) prior to step 2 randomization
  • STEP 2: RANDOMIZATION: Participants must have had a PET-CT scan upon completion of all planned bridging therapy if received, with the exception of up to 7 days of corticosteroids. If the PET-CT scan after completion of bridging therapy was consistent with complete remission per Lugano criteria as determined by enrolling physician, that participant will be ineligible for step 2 randomization.

  • If response assessment by central review cannot be completed (I.e., poor quality of PET-CT scan, PET-CT performed out of window, etc.) this would be recorded as 'inadequate assessment' and patient would not be eligible for randomization
  • STEP 2: RANDOMIZATION: Participants must have Zubrod PS of 0, 1, or 2
  • STEP 2: RANDOMIZATION: Absolute neutrophil count (ANC) >= 1.0 x 10\^3/uL and participants must not have received myeloid growth factor within 72 hours prior to this lab being drawn (within 7 days prior to step 2 randomization)
  • STEP 2: RANDOMIZATION: Platelets >= 75 x 10\^3/uL and participants must not have received platelet transfusion within 72 hours prior to this lab being drawn (within 7 days prior to step 2 randomization)
  • STEP 2: RANDOMIZATION: Total bilirubin =< 2 x institutional ULN (within 7 days prior to step 2 randomization)

  • Unless due to Gilbert's disease or lymphomatous involvement of liver
  • STEP 2: RANDOMIZATION: AST and ALT =< 3 x institutional ULN (within 7 days prior to step 2 randomization)
  • STEP 2: RANDOMIZATION: Creatinine clearance >= 40 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 7 days prior to step 2 randomization. Estimated creatinine clearance is based on actual body weight (within 7 days prior to step 2 randomization)
  • STEP 2: RANDOMIZATION: Participants with peripheral neuropathy must have < grade 2
  • STEP 2: RANDOMIZATION: Participants with current symptoms of cardiac disease must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
  • STEP 2: RANDOMIZATION: Participants with history of hepatitis B viral infection must have undetectable viral load within 14 days prior to step 2 randomization and on suppressive therapy
  • STEP 2: RANDOMIZATION: Participants with history of hepatitis C viral infection must have undetectable viral load within 14 days prior to step 2 randomization
  • STEP 2: RANDOMIZATION: Participants with known human immunodeficiency virus (HIV)-infection must be continuing to receive anti-retroviral therapy and have an undetectable viral load test within 14 days prior to step 2 randomization
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have documented disease progression while on Arm 4 (observation) on this protocol. The follow-up tumor assessment form documenting disease progression must be submitted to SWOG prior to step 3 crossover registration
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must be registered within 28 days of the date of progression
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have imaging that clearly demonstrates progression compared to day +30 PET-CT scan

  • Note: These scans should be performed as standard of care and only performed between scheduled response assessments required for study if symptoms arise that are concerning for progression
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants must have Zubrod PS of 0, 1, or 2
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): ANC >= 1.0 x 10\^3/uL and participants must not have received myeloid growth factor within 72 hours prior to this lab being drawn (within 14 days prior to step 3 crossover registration)
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Platelets >= 75 x 10\^3/uL and participants must not have received platelet transfusion within 72 hours prior to this lab being drawn (within 14 days prior to step 3 crossover registration)
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Total bilirubin =< 2 x institutional ULN (within 14 days prior to step 3 crossover registration)

  • Unless due to Gilbert's disease or lymphomatous involvement of liver
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): AST and ALT =< 3 x institutional ULN
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Creatinine clearance >= 40 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within days prior to step 3 crossover registration. Estimated creatinine clearance is based on actual body weight (within 14 days prior to step 3 crossover registration)
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with peripheral neuropathy must have < grade 2
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with current symptoms of cardiac disease must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with history of hepatitis B viral infection must have undetectable viral load within 14 days prior to step 3 crossover registration and on suppressive therapy
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with history of hepatitis C viral infection must have undetectable viral load within 14 days prior to step 3 crossover registration
  • STEP 3: CROSSOVER REGISTRATION (ARM 4 ONLY): Participants with known human immunodefici

Study Design

Enrollment

396 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Step I (lymphodepleting chemotherapy)

Patients receive lymphodepleting chemotherapy consisting of fludarabine IV and cyclophosphamide IV on study. Patients then receive tisagenlecleucel IV, axicabtagene ciloleucel IV, or lisocabtagene maraleucel IV on study.

experimental: Step II Arm I (mosunetuzumab)

Patients receive mosunetuzumab IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.

experimental: Step II Arm II (polatuzumab vedotin)

Patients receive polatuzumab vedotin IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.

experimental: Step II Arm III (polatuzumab vedotin, mosunetuzumab)

Patients receive polatuzumab vedotin IV and mosunetuzumab IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.

active comparator: Step II Arm IV (observation)

Patients undergo observation on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study. Patients with subsequent progression within 12 months of CAR T-cell therapy may crossover to Arm III.

Interventions

Axicabtagene Ciloleucel

Given IV

Biospecimen Collection

Undergo collection of blood and tissue samples

Computed Tomography

Undergo PET-CT or CT

Cyclophosphamide

Given IV

Fludarabine

Given IV

Lisocabtagene Maraleucel

Given IV

Mosunetuzumab

Given IV

Patient Observation

Undergo observation

Polatuzumab Vedotin

Given IV

Positron Emission Tomography

Undergo PET-CT

Tisagenlecleucel

Given IV

Primary outcome measure

  • Progression free survival (PFS) [ Time Frame: From date of randomization to date of first observation of progressive disease or death due to any cause, assessed up to 2 years ]

Central Contacts and Locations

Central contacts

Erin Rogers

210-614-8808erogers@swog.org

Dana Sparks

210-614-8808dsparks@swog.org

Locations

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Muhammad Husnain

University of Arizona Cancer Center-North Campus

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Muhammad Husnain

Highlands Oncology Group - Fayetteville

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Site Public Contact

479-872-8100research@hogonc.com

Principal Investigator:

Joseph T. Beck

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Site Public Contact

501-686-8274

Principal Investigator:

Cesar Gentille

Highlands Oncology Group - Rogers

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Site Public Contact

479-872-8130research@hogonc.com

Principal Investigator:

Joseph T. Beck

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Site Public Contact

479-872-8130research@hogonc.com

Principal Investigator:

Joseph T. Beck

UC Irvine Health Cancer Center-Newport

Recruiting

Costa Mesa, California, United States, 92627

Contacts

Site Public Contact

877-827-8839

Principal Investigator:

Elizabeth A. Brem

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Elizabeth A. Brem

UCI Health Laguna Hills

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Elizabeth A. Brem

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Elizabeth A. Brem

UCSF Medical Center-Parnassus

Recruiting

San Francisco, California, United States, 94143

Contacts

Site Public Contact

877-827-3222

Principal Investigator:

Madhav R. Seshadri

UF Health Cancer Institute - Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Site Public Contact

352-273-8010cancer-center@ufl.edu

Principal Investigator:

Dina G. Khalaf

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Kristie A. Blum

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Kristie A. Blum

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Charles W. Drescher

Saint Luke's Cancer Institute - Fruitland

Recruiting

Fruitland, Idaho, United States, 83619

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Charles W. Drescher

Saint Luke's Cancer Institute - Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Charles W. Drescher

Saint Luke's Cancer Institute - Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Charles W. Drescher

Saint Luke's Cancer Institute - Twin Falls

Recruiting

Twin Falls, Idaho, United States, 83301

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Charles W. Drescher

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Carlos Galvez

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Site Public Contact

773-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Justin P. Kline

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Eric Mou

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Marc S. Hoffmann

University of Kansas Cancer Center-Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Marc S. Hoffmann

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Marc S. Hoffmann

The James Graham Brown Cancer Center at University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Public Contact

502-562-3429

Principal Investigator:

Hassaan Yasin

UofL Health Medical Center Northeast

Recruiting

Louisville, Kentucky, United States, 40245

Contacts

Site Public Contact

502-852-2755ctoinfo@louisville.edu

Principal Investigator:

Hassaan Yasin

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Jean A. Yared

Johns Hopkins University/Sidney Kimmel Cancer Center

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Site Public Contact

410-955-8804jhcccro@jhmi.edu

Principal Investigator:

Cole H. Sterling

Bronson Battle Creek

Recruiting

Battle Creek, Michigan, United States, 49017

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Wayne State University/Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Joseph P. Uberti

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Site Public Contact

313-916-3721CTOResearch@hfhs.org

Principal Investigator:

Philip Kuriakose

Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Site Public Contact

313-576-9790ctoadmin@karmanos.org

Principal Investigator:

Joseph P. Uberti

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Trinity Health Grand Rapids Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Beacon Kalamazoo Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49009

Contacts

Site Public Contact

574-647-7370

Principal Investigator:

Kathleen Y. Butler

Trinity Health Muskegon Hospital

Recruiting

Muskegon, Michigan, United States, 49444

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Niles Hospital

Recruiting

Niles, Michigan, United States, 49120

Contacts

Site Public Contact

616-391-1230

Principal Investigator:

Kathleen Y. Butler

Cancer and Hematology Centers of Western Michigan - Norton Shores

Recruiting

Norton Shores, Michigan, United States, 49444

Contacts

Site Public Contact

616-391-1230connie.szczepanek@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Corewell Health Reed City Hospital

Recruiting

Reed City, Michigan, United States, 49677

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Recruiting

Saint Joseph, Michigan, United States, 49085

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Munson Medical Center

Recruiting

Traverse City, Michigan, United States, 49684

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

University of Michigan Health - West

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Site Public Contact

800-639-6918cancer.research.nurse@dartmouth.edu

Principal Investigator:

Charles Gaulin

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Site Public Contact

505-925-0348HSC-ClinicalTrialInfo@salud.unm.edu

Principal Investigator:

Matthew Fero

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

Recruiting

New York, New York, United States, 10032

Contacts

Site Public Contact

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Hua-Jay J. Cherng

University of Rochester

Recruiting

Rochester, New York, United States, 14642

Contacts

Site Public Contact

585-275-5830

Principal Investigator:

Patrick M. Reagan

Wilmot Cancer Institute at Webster

Recruiting

Webster, New York, United States, 14580

Contacts

Site Public Contact

WCICTOresearch@urmc.rochester.edu

Principal Investigator:

Patrick M. Reagan

Carolinas Medical Center/Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Site Public Contact

800-804-9376

Principal Investigator:

Nilanjan Ghosh

Atrium Health Cabarrus/LCI-Concord

Recruiting

Concord, North Carolina, United States, 28025

Contacts

Site Public Contact

800-804-9376

Principal Investigator:

Nilanjan Ghosh

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Rakhee Vaidya

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Site Public Contact

701-323-5760OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Site Public Contact

701-234-6161OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Site Public Contact

800-641-2422CTUReferral@UHhospitals.org

Principal Investigator:

Changchun Deng

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Sami Ibrahimi

Providence Newberg Medical Center

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Charles W. Drescher

Providence Willamette Falls Medical Center

Recruiting

Oregon City, Oregon, United States, 97045

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Charles W. Drescher

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Charles W. Drescher

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Charles W. Drescher

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080trials@ohsu.edu

Principal Investigator:

Andy I. Chen

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Joseph P. Lynch

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Site Public Contact

215-349-8245PMCancerResearch@pennmedicine.upenn.edu

Principal Investigator:

Nasheed M. Hossain

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Joseph P. Lynch

Prisma Health Cancer Institute - Spartanburg

Recruiting

Boiling Springs, South Carolina, United States, 29316

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Site Public Contact

843-792-9321hcc-clinical-trials@musc.edu

Principal Investigator:

Brian T. Hess

Prisma Health Cancer Institute - Easley

Recruiting

Easley, South Carolina, United States, 29640

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Butternut

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Faris

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Eastside

Recruiting

Greenville, South Carolina, United States, 29615

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Greer

Recruiting

Greer, South Carolina, United States, 29650

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Prisma Health Cancer Institute - Seneca

Recruiting

Seneca, South Carolina, United States, 29672

Contacts

Site Public Contact

864-522-4317Kim.Williams3@prismahealth.org

Principal Investigator:

Suzanne R. Fanning

Baptist Memorial Hospital and Cancer Center-Memphis

Recruiting

Memphis, Tennessee, United States, 38120

Contacts

Site Public Contact

901-226-1366BCCclintrials@bmhcc.org

Principal Investigator:

Brion V. Randolph

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Site Public Contact

802-656-4101rpo@uvm.edu

Principal Investigator:

James N. Gerson

University of Vermont and State Agricultural College

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Site Public Contact

802-656-8990rpo@uvm.edu

Principal Investigator:

James N. Gerson

Dartmouth Cancer Center - North

Recruiting

Saint Johnsbury, Vermont, United States, 05819

Contacts

Site Public Contact

800-639-6918cancer.research.nurse@hitchcock.org

Principal Investigator:

Charles Gaulin

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430CTOclinops@vcu.edu

Principal Investigator:

Sneha Purvey

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Site Public Contact

206-215-2343PCRC-NCORP@Swedish.org

Principal Investigator:

Charles W. Drescher

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Recruiting

Madison, Wisconsin, United States, 53718

Contacts

Site Public Contact

800-622-8922clinicaltrials@cancer.wisc.edu

Principal Investigator:

Priyanka Pophali

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Site Public Contact

800-622-8922clinicaltrials@cancer.wisc.edu

Principal Investigator:

Priyanka Pophali

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Mehdi Hamadani

Froedtert and MCW Moorland Reserve Health Center

Recruiting

New Berlin, Wisconsin, United States, 53151

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Mehdi Hamadani

More Information

Sponsor

SWOG Cancer Research Network

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SWOG Cancer Research Network on 2026-02-02.