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NCT05458297Active, not recruitingPhase 2

A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006)

A Multicenter, Open-label, Phase 2 Basket Study to Evaluate the Safety and Efficacy of MK-2140 as a Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (waveLINE-006)

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

The purpose of this study is to assess the safety and tolerability of zilovertamab vedotin as monotherapy and in combination in participants with select B-cell lymphomas including mantle cell lymphoma (MCL), Richter's transformation lymphoma (RTL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). This study will also evaluate zilovertamab vedotin as monotherapy and in combination with respect to objective response rate. * Cohort A: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor (BTKi), and post therapy chimeric antigen receptor T (CAR-T) cell therapy or ineligible for CAR-T cell therapy * Cohort B: Participants with relapsed or refractory RT disease after at least 1 prior systemic therapy * Cohort C: Participants with relapsed or refractory MCL relapsed or refractory disease after at least 1 prior systemic therapy and no prior exposure to a non-covalent BTKi * Cohort D: Participants with relapsed or refractory FL and CLL relapsed or refractory disease after at least 2 prior systemic therapies and have no other available therapy * Cohort E: Participants with relapsed or refractory FL after at least 2 prior systemic therapies and have no other available therapy The primary study hypothesis is that zilovertamab vedotin monotherapy has an increased Objective Response Rate (ORR) per Lugano Response Criteria as assessed by blinded independent central review (BICR). As of Amendment 07, Cohort D is closed to enrollment of participants with CLL and enrollment of participants into Arm 2 (zilovertamab vedotin at Dose 2 on Days 1 \& 8 of each 3 Week Cycle (Q2/3W)). As of Amendment 09, no additional participants with RT will be enrolled in Cohort B; however, those currently enrolled will continue with study intervention treatment (if applicable) until a protocol specified discontinuation criterion is met. Cohort E will be closed, as no participants with FL have been treated in this cohort.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
189 (estimated)
First submitted
11 Jul 2022
Start date
21 Jul 2022
Primary completion date
17 May 2029
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05458297
EU CT number
2022-501374-19-00
EudraCT number
2021-004450-36

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 189
  • From 21 Jul 2022 to the primary completion date, 17 May 2029
  • 105 sites in 21 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received solid organ transplant at any time.
  • Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina (\<6 months prior to enrollment), congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
  • Has received prior systemic anticancer therapy within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibodies) or 2 weeks (if prior therapy was small molecules like kinase inhibitors) prior to the first dose of study intervention.
  • Has received prior radiotherapy within 28 days of start of study intervention. Participants must have recovered from all radiation-related toxicities.
  • Has ongoing corticosteroid therapy exceeding 30 mg daily of prednisone equivalent.
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.

Other illness

  • Has a demyelinating form of Charcot-Marie-Tooth disease.
  • Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
  • Has an active infection requiring systemic therapy.
  • Has a known history of human immunodeficiency virus (HIV) infection not well controlled on antiretroviral therapy (ART)
  • Active HBV or hepatitis C virus (HCV) infection.

Other

  • Has pericardial effusion or clinically significant pleural effusion.
  • Has ongoing Grade \>1 peripheral neuropathy.
  • Participants with FL who have transformed to a more aggressive type of lymphoma.
  • Has known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.
  • For Cohort C only: has any clinically significant gastrointestinal abnormalities that might alter absorption.

Who the study is looking for

  • For aggressive B-cell malignancies mantle cell lymphoma (MCL): Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor(s) (BTKi), and is post chimeric antigen receptor T (CAR-T) cell therapy or is ineligible for CAR-T cell therapy.
  • For aggressive B-cell malignancies MCL Cohort C: Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 1 prior systemic therapy and has no prior exposure to a non-covalent BTKi.
  • For aggressive B-cell malignancies Richter transformation lymphoma (RTL): Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease.
  • For indolent B-cell malignancies follicular lymphoma (FL) and chronic lymphocytic leukemia (CLL): Has histologically confirmed biopsy and has relapsed or refractory disease after at least 2 prior systemic therapies and no other available therapy.
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization/allocation.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before cycle 1 day 1.

Criteria the registry did not label

  • The main inclusion criteria include, but are not limited to the following:

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (105)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 1807)
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NatalBrazilUnknown status
Instituto Nacional de Câncer - INCA-Divisão de Pesquisa Clínica e Desenvolvimento Tecnológico HC1 ( Site 1809)
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Rio de JaneiroBrazilUnknown status
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1808)
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São PauloBrazilUnknown status
Hospital Paulistano-Americas Oncologia ( Site 1805)
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São PauloBrazilUnknown status
QEII Health Sciences Centre - Victoria General Site ( Site 0213)
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HalifaxCanadaUnknown status
London Health Sciences Centre ( Site 0203)
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LondonCanadaUnknown status
The Moncton Hospital-Oncology ( Site 0211)
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MonctonCanadaUnknown status
Jewish General Hospital ( Site 0202)
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MontrealCanadaUnknown status
Allan Blair Cancer Centre-Care Services ( Site 0208)
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ReginaCanadaUnknown status
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)
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TorontoCanadaUnknown status
BC Cancer Vancouver-Clinical Trials Unit ( Site 0201)
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VancouverCanadaUnknown status
IC La Serena Research ( Site 1909)
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La SerenaChileUnknown status
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1907)
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SantiagoChileUnknown status
Clínica Alemana de Santiago ( Site 1903)
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SantiagoChileUnknown status
Clínica Inmunocel ( Site 1910)
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SantiagoChileUnknown status
Beijing Cancer hospital ( Site 1200)
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BeijingChinaUnknown status
West China Hospital of Sichuan University-Head and Neck Oncology ( Site 1206)
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ChengduChinaUnknown status
Jilin Province Tumor Hospital-oncology department ( Site 1220)
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ChuangchunChinaUnknown status
Sun Yat-sen University Cancer Center ( Site 1201)
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GuangzhouChinaUnknown status
Zhujiang Hospital ( Site 1207)
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GuangzhouChinaUnknown status
Southern Medical University Nanfang Hospital ( Site 1202)
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GuangzhouChinaUnknown status
Zhejiang Cancer Hospital ( Site 1214)
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HangzhouChinaUnknown status
The First Affiliated Hospital, Zhejiang University ( Site 1211)
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HangzhouChinaUnknown status
The First Affiliated Hospital of Nanchang University ( Site 1204)
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NanchangChinaUnknown status
Jiangxi Provincial Cancer Hospital ( Site 1213)
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NanchangChinaUnknown status
Fudan University Shanghai Cancer Center ( Site 1208)
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ShanghaiChinaUnknown status
The First Affiliated Hospital of Soochow University-hematology department ( Site 1218)
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SuzhouChinaUnknown status
Tongji Hospital Tongji Medical,Science & Technology ( Site 1221)
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WuhanChinaUnknown status
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1210)
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WuhanChinaUnknown status
The Affiliated Hospital of Xuzhou Medical College ( Site 1223)
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XuzhouChinaUnknown status
Henan Cancer Hospital-hematology department ( Site 1212)
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ZhengzhouChinaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaActive, not recruiting
University Hospital Cologne AöR
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CologneGermanyCompleted
Universitaetsklinikum Ulm AoR
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UlmGermanyCompleted
North Estonia Medical Centre Foundation
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TallinnEstoniaCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainActive, not recruiting
Hospital Clínico San Carlos
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MadridSpainActive, not recruiting
MD Anderson Cancer Center
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario De Salamanca
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SalamancaSpainActive, not recruiting
University College London Hospital ( Site 7001)
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LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust ( Site 7007)
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ManchesterUnited KingdomUnknown status
The Churchill Hospital ( Site 7002)
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OxfordUnited KingdomUnknown status
The Royal Cornwall Hospital-Haematology ( Site 7006)
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TruroUnited KingdomUnknown status
St James's Hospital
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Dublin 8IrelandCompleted
Emek Medical Center-Hematology Unit ( Site 0705)
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AfulaIsraelUnknown status
Soroka Medical Center-Hematology Department ( Site 0707)
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BeershebaIsraelUnknown status
Carmel Hospital ( Site 0709)
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HaifaIsraelUnknown status
Rambam Health Care Campus-Hematology and Bone Marrow Transplantation ( Site 0706)
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HaifaIsraelUnknown status
Hadassah Medical Center ( Site 0701)
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JerusalemIsraelUnknown status
Galilee Medical Center ( Site 0710)
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NahariyaIsraelUnknown status
Sheba Medical Center-Hemato Oncology ( Site 0700)
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Ramat GanIsraelUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Humanitas Research Hospital
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RozzanoItalyActive, not recruiting
National Cancer Center Hospital ( Site 1103)
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Chuo-kuJapanUnknown status
Kyushu University Hospital ( Site 1105)
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FukuokaJapanUnknown status
Tokai University Hospital ( Site 1100)
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IseharaJapanUnknown status
Cancer Institute Hospital of JFCR ( Site 1101)
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KotoJapanUnknown status
National Hospital Organization Nagoya Medical Center ( Site 1108)
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NagoyaJapanUnknown status
Okayama University Hospital ( Site 1107)
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OkayamaJapanUnknown status
Kindai University Hospital ( Site 1102)
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SakaiJapanUnknown status
Hokkaido University Hospital ( Site 1104)
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SapporoJapanUnknown status
Tohoku University Hospital ( Site 1106)
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SendaiJapanUnknown status
Samsung Medical Center ( Site 1301)
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SeoulSouth KoreaUnknown status
Seoul National University Hospital ( Site 1300)
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SeoulSouth KoreaUnknown status
Centro Medico Monte Carmelo ( Site 1702)
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ArequipaPeruUnknown status
INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS ( Site 1700)
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LimaPeruUnknown status
Pratia S.A.
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CracowPolandActive, not recruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandActive, not recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandActive, not recruiting
Centrum Onkologii Ziemi Lubelskiej im sw Jana z Dukli
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LublinPolandActive, not recruiting
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie
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OlsztynPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Champalimaud Clinical Centre
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LisbonPortugalActive, not recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalActive, not recruiting
Uppsala University Hospital
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UppsalaSwedenActive, not recruiting
National Cancer Centre Singapore ( Site 1500)
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SingaporeSingaporeUnknown status
Alaska Oncology and Hematology ( Site 0037)
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AnchorageUnited StatesUnknown status
University of Michigan ( Site 0009)
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Ann ArborUnited StatesUnknown status
University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008)
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AuroraUnited StatesUnknown status
Greenebaum Comprehensive Cancer Center-Hematology & Multiple Myeloma ( Site 0010)
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BaltimoreUnited StatesUnknown status
Tufts Medical Center ( Site 0024)
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BostonUnited StatesUnknown status
Dana-Farber Cancer Institute-Lymphoma ( Site 0026)
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BostonUnited StatesUnknown status
Massachusetts General Hospital ( Site 0018)
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BostonUnited StatesUnknown status
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0004)
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ColumbusUnited StatesUnknown status
Cancer Care Specialists of Illinois ( Site 0031)
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DecaturUnited StatesUnknown status
Henry Ford Hospital ( Site 0035)
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DetroitUnited StatesUnknown status
University of Kansas Medical Center-Division of Hematologic Malignancies and Cellular Therapeutics ( Site 0038)
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FairwayUnited StatesUnknown status
Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0014)
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FargoUnited StatesUnknown status
Banner MD Anderson Cancer Center ( Site 0040)
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GilbertUnited StatesUnknown status
University of Wisconsin Hospitals and Clinics-Carbone Cancer Center ( Site 0030)
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MadisonUnited StatesUnknown status
Medical College of Wisconsin ( Site 0021)
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MilwaukeeUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai ( Site 0023)
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New YorkUnited StatesUnknown status
Banner MD Anderson Cancer Center - University Medical Center Phoenix-Medical Oncology ( Site 0036)
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PhoenixUnited StatesUnknown status
Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0007)
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Saint MatthewsUnited StatesUnknown status
Avera Cancer Institute- Research ( Site 0011)
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Sioux FallsUnited StatesUnknown status
Medical Oncology Associates, PS ( Site 0005)
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SpokaneUnited StatesUnknown status
Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 6001)
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AnkaraTurkey (Türkiye)Unknown status
Ege Universitesi Hastanesi ( Site 6002)
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BornovaTurkey (Türkiye)Unknown status
Trakya University ( Site 6005)
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EdirneTurkey (Türkiye)Unknown status
Ondokuz Mayıs Universitesi-Oncology department ( Site 6004)
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SamsunTurkey (Türkiye)Unknown status
Mega Medipol-Hematology ( Site 6009)
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StanbulTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.