Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment
NCT ID: NCT05890352
Last Updated: 2025-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
227 participants
INTERVENTIONAL
2023-09-26
2029-01-31
Brief Summary
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Detailed Description
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I. To determine the recommended phase II dose of tafasitamab + lenalidomide + tazemetostat AND of tafasitamab + lenalidomide + zanubrutinib. (Safety Run-in) II. To compare progression-free survival (PFS) of patients with relapsed/refractory large B-cell lymphoma (R/R LBCL) treated with tafasitamab + lenalidomide + tazemetostat vs control (tafasitamab + lenalidomide) AND treated with tafasitamab + lenalidomide + zanubrutinib versus (vs) control. (Randomized Phase II Study)
SECONDARY OBJECTIVES:
I. To estimate the hazard ratio for PFS for control vs. tafasitamab + lenalidomide + tazemetostat in germinal center B-cell (GCB) and non-GCB (activated B-cell \[ABC\]/unclassified) subsets.
II. To estimate the hazard ratio for PFS for control vs. tafasitamab + lenalidomide + zanubrutinib in GCB and non-GCB (ABC/unclassified) subsets.
III. To estimate progression-free survival (PFS), overall response rate (ORR), complete response rate (CR), partial response rate (PR), duration of response (DOR), event-free survival (EFS), overall survival (OS), in GCB and non-GCB LBCL for each treatment.
IV. To evaluate adverse events within each treatment arm.
OTHER OBJECTIVES:
I. To explore PFS within subgroups defined by molecular profile (e.g., MCD, BN2, N1 and EZB) and genetic subtypes.
II. To explore PFS in the tafasitamab-lenalidomide control arm vs that in matched historical control from L-MIND and realMIND studies.
III. To assess frailty (Cumulative Illness Rating Scale \[CIRS\] and Timed Get Up and Go \[TUG\]) and its correlation with outcome.
PRIMARY PATIENT-REPORTED OUTCOMES OBJECTIVE:
I. To compare patient-reported lymphoma-specific symptoms as measured by the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Trial Outcome Index sub-scale at 3 months after randomization between the control arm and each experimental arm (Arm 1 versus Arm 2 and Arm 3 versus Arm 2).
SECONDARY PATIENT-REPORTED OUTCOMES OBJECTIVE:
I. To compare participant-reported toxicity (treatment side effect) symptoms using selected Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) items between experimental vs control arms.
EXPLORATORY PATIENT-REPORTED OUTCOMES OBJECTIVES:
I. To compare patient-reported quality of life using the FACT-General (G) subscale score and the FACT-Lym total score at 3 months after randomization between the control arm and each experimental arm.
II. To compare quality of life over time between treatment arms from baseline to 12 months after randomization as measured by the FACT-Lym trial outcome index (TOI), FACT-G, and FACT-Lym total score using longitudinal analysis.
BANKING OBJECTIVE:
I. To bank specimens for future correlative studies.
OUTLINE: This is a dose-escalation study of tazemetostat and zanubrutinib.
PART I (SAFETY RUN-IN): Patients are assigned to 1 of 2 arms per treating investigator's choice.
ARM I: Patients receive tafasitamab intravenously (IV), lenalidomide orally (PO), and tazemetostat PO on study. Patients also undergo positron emission tomography/computed tomography (PET/CT) and CT or magnetic resonance imaging (MRI) scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
ARM III: Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
PART II: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
ARM II: Patients receive tafasitamab IV and lenalidomide PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
ARM III: Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part I, Arm I (tafasitamab, lenalidomide, tazemetostat)
Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Biospecimen Collection
Undergo optional collection of blood
Computed Tomography
Undergo PET/CT and CT
Lenalidomide
Given PO
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Quality-of-Life Assessment
Ancillary studies
Tafasitamab
Given IV
Tazemetostat
Given PO
Part I, Arm III (tafasitamab, lenalidomide, zanubrutinib)
Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Biospecimen Collection
Undergo optional collection of blood
Computed Tomography
Undergo PET/CT and CT
Lenalidomide
Given PO
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Tafasitamab
Given IV
Zanubrutinib
Given PO
Part II, Arm I (tafasitamab, lenalidomide, tazemetostat)
Patients receive tafasitamab IV, lenalidomide PO, and tazemetostat PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Biospecimen Collection
Undergo optional collection of blood
Computed Tomography
Undergo PET/CT and CT
Lenalidomide
Given PO
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Tafasitamab
Given IV
Tazemetostat
Given PO
Part II, Arm II (tafasitamab, lenalidomide)
Patients receive tafasitamab IV and lenalidomide PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Biospecimen Collection
Undergo optional collection of blood
Computed Tomography
Undergo PET/CT and CT
Lenalidomide
Given PO
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Tafasitamab
Given IV
Part II, Arm III (tafasitamab, lenalidomide, zanubrutinib)
Patients receive tafasitamab IV, lenalidomide PO, and zanubrutinib PO on study. Patients also undergo PET/CT and CT or MRI scans throughout the trial. Patients also have the option to undergo collection of blood samples during screening and on study.
Biospecimen Collection
Undergo optional collection of blood
Computed Tomography
Undergo PET/CT and CT
Lenalidomide
Given PO
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Tafasitamab
Given IV
Zanubrutinib
Given PO
Interventions
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Biospecimen Collection
Undergo optional collection of blood
Computed Tomography
Undergo PET/CT and CT
Lenalidomide
Given PO
Magnetic Resonance Imaging
Undergo MRI
Positron Emission Tomography
Undergo PET/CT
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Tafasitamab
Given IV
Tazemetostat
Given PO
Zanubrutinib
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed relapsed/refractory LBCL as outlined by the World Health Organization (WHO) guidelines
* Follicular lymphoma, grade 3B
* Transformed lymphoma
* High grade B-cell lymphoma with or without MYC, BCL2 and/or BCL6 rearrangements
* Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline. Note: PET-CT will be required at end of treatment (EOT) and progression for response assessment. All measurable lesions (longest diameter \>= 1.5 cm) must be assessed within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 28 days prior to registration. All disease must be documented on the Baseline Tumor Assessment Form.
* Participants must have cell of origin (COO) determination of germinal center (GC)(GCB or non-GC GCB) of LBCL based on Hans immunohistochemistry algorithm (CD10, BCL6, MUM1) as noted on pathology report.
* Participants must have had 1-5 prior systemic treatment regimens including one systemic multiagent regimen for aggressive lymphoma
* Participants who have received prior systemic therapy must have completed their last treatment prior to registration. Participants must have recovered from previous therapy
* Steroid use for the control of non-Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to Cycle 1, Day 1
* Participant must be \>= 18 years old
* Participant must have Zubrod Performance Status of 0-3
* Participant must have a complete medical history and physical exam within 28 days prior to registration
* Absolute neutrophil count \>= 1.0 x 10\^3/uL (within 28 days prior to registration)
* If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants must have: Absolute neutrophil count (ANC) \>= 0.75 x 10\^3/uL
* Platelets \>= 75 x 10\^3/uL (within 28 days prior to registration)
* If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants must have: Platelets \>= 50 x 10\^3/uL
* Aspartate aminotransferase (AST) =\< 3 x institutional upper limit of normal (IULN), alanine aminotransferase (ALT) =\< 3 x IULN (within 28 days prior to registration) unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver.
* Participants with lymphomatous involvement of the liver must have AST =\< 5 x IULN, ALT =\< 5 x IULN
* Total bilirubin =\< 1.5 x IULN (within 28 days prior to registration) unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver.
* Participants with lymphomatous involvement of the liver must have total bilirubin =\< 5 x IULN
* Participants must have a calculated creatinine clearance \>= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
* Participants must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia
* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy
* Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to registration
* Participants must be able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels
* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
* Participants who can complete the FACT-Lym and PRO-CTCAE forms in English or Spanish must agree to participate in the patient-reported outcome study
* 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.
Exclusion Criteria
* Participants must not have known abnormalities associated with myelodysplastic syndrome (MDS) (e.g., del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g., JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing. Testing is not required for eligibility determination
* Participants must not have a known prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute leukemia (T-ALL). Testing is not required for eligibility determination
* Participants must not be a candidate based on investigator assessment to receive autologous stem cell transplant (ASCT) or must have declined ASCT. Participants who had disease progression after stem cell transplant or cellular therapy (such as chimeric antigen receptor (CAR) T-cell) are eligible
* Participants must not have received prior treatment with tafasitamab and/or lenalidomide
* Participants must not have had prior BTK inhibitor or tazemetostat
* Participants must not have any known allergy or reaction to any component of tafasitamab, lenalidomide, tazemetostat or zanubrutinib
* Participants must not be receiving direct vitamin K inhibitors or strong or moderate CYP3A inhibitors or inducers at the date of registration
* Notes: Because the list of these agents is constantly changing, it is important to regularly consult a frequently updated medical reference
* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
* Participants must not be pregnant or nursing and must follow the guidelines according to the lenalidomide Risk Evaluation and Mitigation Strategies (REMS) program. The effects of tazemetostat, zanubrutinib, lenalidomide and tafasitamab, and the combination of these drugs have not been studied on the developing human fetus are the effects are unknown. Individuals who are of reproductive potential must have agreed to use a highly effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential". In addition to routine contraceptive methods, "acceptable contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
BeiGene
INDUSTRY
Ipsen
INDUSTRY
Incyte Corporation
INDUSTRY
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Jennifer E Amengual
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
Tower Cancer Research Foundation
Beverly Hills, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope Seacliff
Huntington Beach, California, United States
City of Hope Antelope Valley
Lancaster, California, United States
City of Hope at Long Beach Elm
Long Beach, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
City of Hope Newport Beach
Newport Beach, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
City of Hope South Bay
Torrance, California, United States
City of Hope Upland
Upland, California, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
University of Illinois
Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois, United States
Memorial Hospital East
Shiloh, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Northwest Cancer Center - Main Campus
Crown Point, Indiana, United States
Northwest Oncology LLC
Dyer, Indiana, United States
Northwest Cancer Center - Hobart
Hobart, Indiana, United States
Saint Mary Medical Center
Hobart, Indiana, United States
Saint Catherine Hospital
Indianapolis, Indiana, United States
The Community Hospital
Munster, Indiana, United States
Women's Diagnostic Center - Munster
Munster, Indiana, United States
Northwest Cancer Center - Valparaiso
Valparaiso, Indiana, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan, United States
Trinity Health Medical Center - Canton
Canton, Michigan, United States
Chelsea Hospital
Chelsea, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan, United States
Cancer Hematology Centers - Flint
Flint, Michigan, United States
Genesee Hematology Oncology PC
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Huron Gastroenterology PC
Ypsilanti, Michigan, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan, United States
Essentia Health - Deer River Clinic
Deer River, Minnesota, United States
Essentia Health Cancer Center
Duluth, Minnesota, United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota, United States
Essentia Health Sandstone
Sandstone, Minnesota, United States
Essentia Health Virginia Clinic
Virginia, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Wilmot Cancer Institute at Webster
Webster, New York, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, United States
Duluth Clinic Ashland
Ashland, Wisconsin, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States
Aurora Medical Center in Summit
Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Site Public Contact
Role: primary
Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Site Public Contact
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Other Identifiers
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NCI-2023-02518
Identifier Type: REGISTRY
Identifier Source: secondary_id
S2207
Identifier Type: OTHER
Identifier Source: secondary_id
S2207
Identifier Type: OTHER
Identifier Source: secondary_id
S2207
Identifier Type: -
Identifier Source: org_study_id
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