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NCT04712097Active, not recruitingPhase 3

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

Phase III Randomized, Open-Label, Multicenter Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a Non-Randomized Single Arm US Extension of Mosunetuzumab in Combination With Lenalidomide in Patients With Follicular Lymphoma After at Least One Line of Systemic Therapy

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

This study will evaluate the efficacy and safety of mosunetuzumab in combination with lenalidomide (M + Len) compared to rituximab in combination with lenalidomide (R + Len) in participants with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of prior systemic therapy.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
478 (actual)
First submitted
13 Jan 2021
Start date
27 Oct 2021
Primary completion date
3 Jun 2026
Lead sponsor
Hoffmann-La Roche
NCT number
NCT04712097
EU CT number
2023-505807-21-00
EudraCT number
2020-005239-53

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 478
  • From 27 Oct 2021 to the primary completion date, 3 Jun 2026
  • 110 sites in 15 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

  • Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
  • Prior standard or investigational anti-cancer therapy as specified: Lenalidomide exposure within 12 months prior to Day 1 of Cycle 1; Chimeric antigen receptor T cell therapy within 30 days prior to Day 1 of Cycle 1; Radioimmunoconjugate within 12 weeks prior to Day 1 of Cycle 1; Monoclonal antibody or antibody-drug conjugate within 4 weeks prior to Cycle 1 Day 1; Treatment with any anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment
  • Clinically significant toxicity (other than alopecia) from prior treatment that has not resolved to Grade \</= 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0) prior to Day 1 of Cycle 1
  • Treatment with systemic immunosuppressive medications, including, but not limited to prednisone (\> 20 mg), azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 2 weeks prior to Day 1 of Cycle 1
  • History of erythema multiforme, Grade \>/= 3 rash, or blistering following prior treatment with immunomodulatory derivatives
  • Known active bacterial, viral, fungal, or other infection, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks of Day 1 of Cycle 1
  • Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study
  • Prior allogeneic stem cell transplantation
  • Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, myocardial infarction within the previous 6 months, unstable arrhythmia, or unstable angina) or significant pulmonary disease (such as obstructive pulmonary disease or history of bronchospasm)
  • Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study

Other illness

  • Any history of disease transformation and/or diffuse-large B cell lymphoma (DLBCL)
  • Active or history of CNS lymphoma or leptomeningeal infiltration
  • History of solid organ transplantation
  • History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies
  • Known sensitivity or allergy to murine products
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the mosunetuzumab, rituximab, tocilizumab, lenalidomide, or thalidomide formulation, including mannitol
  • History of interstitial lung disease, drug-induced pneumonitis, and autoimmune pneumonitis
  • Known or suspected chronic active Epstein-Barr virus (EBV) infection
  • Known or suspected history of hemophagocytic lymphohistiocytosis
  • Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis
  • Active Hepatitis B infection
  • Active Hepatitis C infection
  • Known history of HIV positive status
  • History of progressive multifocal leukoencephalopathy (PML)
  • Other malignancy that could affect compliance with the protocol or interpretation of results
  • Active autoimmune disease requiring treatment
  • History of autoimmune disease, including, but not limited to: myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
  • Contraindication to treatment for thromboembolism prophylaxis

Lab values

  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results

Other

  • Grade 3b FL
  • Pregnant or lactating or intending to become pregnant during the study

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
  • Histologically documented CD20+ FL (Grades 1-3a)
  • Requiring systemic therapy assessed by investigator based on tumor size and/or Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
  • Received at least one prior systemic lymphoma therapy, which included prior immunotherapy or chemoimmunotherapy
  • Availability of a representative tumor specimen and the corresponding pathology report at the time of relapse/persistence for confirmation of the diagnosis of FL. Pretreatment sample of at least 1 core-needle, excisional or incisional tumor biopsy is required. Cytological or fine-needle aspiration samples are not acceptable. Fresh pretreatment biopsy is preferred. Patients who are unable to undergo biopsy procedures may be eligible for study enrollment if an archival tumor tissue sample (preferably from the most recent relapse/persistence) as paraffin blocks or at least 15 unstained slides, or in accordance with local regulatory requirements, can be sent to the Sponsor.
  • Adequate hematologic function (unless due to underlying lymphoma, per the investigator)
  • Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program.
  • For women of childbearing potential: Agreement to remain abstinent (refrain from heterosexual intercourse) or use 2 adequate methods of contraception, including at least 1 method with a failure rate of \< 1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), and for at least 28 days after the last dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab, and 12 months after final dose of rituximab. Women must refrain from donating eggs during this same period.
  • For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 28 days after last dose of lenalidomide, 3 months after the final dose of tocilizumab (if applicable), mosunetuzumab and 12 months after the final dose of rituximab. Men must refrain from donating sperm during this same period.

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

Full criteria on ClinicalTrials.gov

Sites (110)

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

SiteCityCountrySite status
Royal Adelaide Hospital
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AdelaideAustraliaUnknown status
Geelong Hospital
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GeelongAustraliaUnknown status
Calvary Mater Newcastle
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WaratahAustraliaUnknown status
Princess Alexandra Hospital Woolloongabba
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WoolloongabbaAustraliaUnknown status
Ictrials Pesquisa e Desenvolvimento
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CuritibaBrazilUnknown status
Hospital das Clinicas - UFRGS
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Porto AlegreBrazilUnknown status
Hospital Mae de Deus
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Porto AlegreBrazilUnknown status
Hospital Alemão Oswaldo Cruz
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São PauloBrazilUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
Cancer Center, Sun Yat-sen University of Medical Sciences
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GuangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
The 1st Affiliated Hospital of Nanchang Unversity
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NanchangChinaUnknown status
Jiangsu Province Hospital
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NanjingChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
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TianjinChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
Zhejiang Cancer Hospital
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ZhejiangChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Vivantes Netzwerk fuer Gesundheit GmbH
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BerlinGermanyActive, not recruiting
Gemeinschaftspraxis Haematologie Onkologie
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DresdenGermanyActive, not recruiting
Martin-Luther-Universitaet Halle-Wittenberg
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Halle (Saale)GermanyActive, not recruiting
Universitaetsklinikum Heidelberg AöR
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HeidelbergGermanyActive, not recruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyActive, not recruiting
Rostock University Medical Center
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RostockGermanyActive, not recruiting
Hospital Universitario Donostia
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DonostiaSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital General Universitario Morales Meseguer
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MurciaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
Centre Hospitalier de la Cote Basque
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BayonneFranceActive, not recruiting
Centre Hospitalier Métropole Savoie
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ChambéryFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Creteil CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
CHU de Montpellier
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Montpellier Cedex 05FranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceActive, not recruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceActive, not recruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceActive, not recruiting
Hopital Saint Louis
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ParisFranceActive, not recruiting
Hopital Saint Antoine
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Paris Cedex 12FranceActive, not recruiting
Centre Hospitalier Universitaire De Bordeaux
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Pessac CedexFranceActive, not recruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceActive, not recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceActive, not recruiting
Centre Hospitalier Universitaire Reims
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Reims CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Centre Henri Becquerel
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RouenFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
Royal Cornwall Hospitals NHS Trust
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CornwallUnited KingdomUnknown status
Hammersmith Hospital
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LondonUnited KingdomUnknown status
Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
Torbay Hospital
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TorquayUnited KingdomUnknown status
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyActive, not recruiting
Careggi University Hospital
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FlorenceItalyActive, not recruiting
Azienda Ospedale Universita Padova
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PadovaItalyActive, not recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyActive, not recruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyActive, not recruiting
Aichi Cancer Center
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AichiJapanUnknown status
National Cancer Center Hospital East
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ChibaJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Mie University Hospital
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MieJapanUnknown status
Tohoku University Hospital
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MiyagiJapanUnknown status
Okayama University Hospital
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OkayamaJapanUnknown status
National Cancer Center Hospital
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TokyoJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Seoul St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Szpitale Pomorskie Sp z o o
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GdyniaPolandActive, not recruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandActive, not recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
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PoznanPolandActive, not recruiting
Instytut Hematologii I Transfuzjologii
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WarsawPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandActive, not recruiting
City Clinical Botkin's Hospital
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MoscowRussiaUnknown status
Penza Regional Oncology Dispensary
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PenzaRussiaUnknown status
Chang Gung Medical Foundation - Kaohsiung;Oncology
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KaoisungTaiwanUnknown status
National Taiwan Universtiy Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation - Linkou
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TaoyuanTaiwanUnknown status
University of Michigan Health System
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Ann ArborUnited StatesUnknown status
Winship Cancer Institute
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AtlantaUnited StatesUnknown status
Johns Hopkins Uni
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BaltimoreUnited StatesUnknown status
Baylor University Medical Center
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DallasUnited StatesUnknown status
City of Hope Comprehensive Cancer Center
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DuarteUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Fort Wayne Medical Oncology and Hematology, Inc
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Fort WayneUnited StatesUnknown status
Cancer & Hematology Center of West Michigan
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Grand RapidsUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesUnknown status
NYU Long Island Hospital
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MineolaUnited StatesUnknown status
NYU Langone Ambulatory Care Center
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New YorkUnited StatesUnknown status
Investigative Clinical Research of Indiana, LLC
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NoblesvilleUnited StatesUnknown status
Washington University
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St LouisUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Montefiore Medical Center- Montefiore Medical Park
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The BronxUnited StatesUnknown status
Wake Forest Univ Health Svcs
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Winston-SalemUnited StatesUnknown status
Hacettepe Uni Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Marmara Ün?Vers?Tes? ?Stanbul Pend?K E??T?M Ve Ara?Tirma Hastanes?
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IstanbulTurkey (Türkiye)Unknown status
Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
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IstanbulTurkey (Türkiye)Unknown status
Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
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SariyerTurkey (Türkiye)Unknown status

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