search
Back to results

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 (Celestimo)

Primary Purpose

Relapsed or Refractory Follicular Lymphoma

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Mosunetuzumab
Lenalidomide
Rituximab
Tociluzumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Follicular Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 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.

Exclusion Criteria:

  • Grade 3b FL
  • History of transformation of indolent disease to diffuse-large B cell lymphoma
  • Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy
  • Active or history of CNS lymphoma or leptomeningeal infiltration
  • 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, 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 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 erythema multiforme, Grade >/= 3 rash, or blistering following prior treatment with immunomodulatory derivatives
  • History of interstitial lung disease, drug-induced pneumonitis, and autoimmune pneumonitis
  • 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
  • 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)
  • 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
  • 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
  • Prior allogeneic stem cell transplantation
  • Contraindication to treatment for thromboembolism prophylaxis
  • 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
  • Pregnant or lactating or intending to become pregnant during the study
  • 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

Sites / Locations

  • City of Hope Comprehensive Cancer CenterRecruiting
  • cCare
  • Fort Wayne Medical Oncology and Hematology, IncRecruiting
  • Johns Hopkins Uni ; Sidney Kimmel Comprehensive Care CenterRecruiting
  • University of Michigan Health System; UMH Internal Medicine/Hematology-OncologyRecruiting
  • Cancer & Hematology Center of West MichiganRecruiting
  • Washington University; Wash Uni. Sch. Of MedRecruiting
  • MD Anderson Cancer Center at CooperRecruiting
  • NYU Long Island HospitalRecruiting
  • NYU Langone Ambulatory Care CenterRecruiting
  • Duke University Medical CenterRecruiting
  • Wake Forest Univ Health Svcs; Section on Hem and OncRecruiting
  • MD Anderson Cancer Center
  • Kadlec Clinic Hematology and OncologyRecruiting
  • Calvary Mater Newcastle
  • Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical OncologyRecruiting
  • Royal Adelaide Hospital; Haematology Clinical Trials
  • Geelong Hospital; Andrew Love Cancer Centre
  • ICTR Curitiba
  • Hospital das Clinicas - UFRGS
  • Hospital Mae de Deus
  • Hospital Alemao Oswaldo CruzRecruiting
  • Peking University First HospitalRecruiting
  • Beijing Cancer Hospital
  • Peking University Third HospitalRecruiting
  • The First Hospital of Jilin UniversityRecruiting
  • Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical OncologyRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • The 1st Affiliated Hospital of Nanchang UnversityRecruiting
  • Jiangsu Province Hospital
  • Fudan University Shanghai Cancer Center; Medical OncologyRecruiting
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting
  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesRecruiting
  • Tianjin Cancer Hospital
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Tongji Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
  • The First Affiliated Hospital of Xiamen University
  • Zhejiang Cancer HospitalRecruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • Centre Hospitalier de La Cote Basque; Hematologie
  • Ch De Chambery; Hematologie Oncologie
  • Hopital Henri Mondor; Hematologie Clinique
  • Hopital Claude Huriez; Hematologie
  • Institut Paoli Calmettes
  • CHU Saint Eloi; Service d'Hématologie Clinique
  • CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique
  • Centre Antoine Lacassagne;B4 Hematologie Cancerologie
  • CHU de Nîmes - Hôpital Carémeau
  • Hôpital Saint-Louis; Service d'Hématologie
  • Hopital Saint Antoine; Hematologie Clinique
  • Hopital De Haut Leveque; Hematologie Clinique
  • Ch Lyon Sud; Hemato Secteur Jules CourmontRecruiting
  • Hopital De La Miletrie; Hematologie Et Oncologie Medicale
  • CHU de Reims
  • CHU Pontchaillou
  • Centre Henri Becquerel; Service HématologieRecruiting
  • ICLN;Hopital De Jour Rdc
  • ICANS
  • Universitätsklinikum Augsburg; II. Med. Klinik
  • Sozialstiftung Bamberg - Klinikum am Bruderwald, Med. Klinik V; Hämatologie und intern. Onkologie
  • Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie
  • CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
  • Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III, Hämatologie und Onkologie
  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
  • Marien-Hospital Klinik f.Hämatologie Onkologie u.Palliativmedizin
  • Medizinische Klinik IV, Hämatologie Universitätsklinikum Gießen
  • Universitätsklinikum Halle; Klinik für Innere Medizin IV; Hämatologie und Onkologie
  • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik VRecruiting
  • Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
  • Westpfalz-Klinikum GmbH; Innere Medizin 1, Hämatologie und internistischen Onkologie
  • Uni-Klinikum-Schleswig-Holstein; Klinik für Innere Medizin II; Hämatologie und Onkologie
  • Universitaetsklinikum Schleswig Holstein - Campus Luebeck; Haematologie, Onkologie
  • Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
  • Klinik und Poliklinik f. Innere Medizin III des Universitätsklinikums Regensburg
  • Universitätsklinik Rostock; Klinik für Innere Med. III, Abteilung Hämatologie/OnkologieRecruiting
  • Universtitätsklinikum Ulm; Klinik für Innere Medizin IIIRecruiting
  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
  • U.O. Ematologia AUSL Ravenna
  • Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
  • Ospedale Di Circolo E Fondazione Macchi; Ematologia
  • Ospedali Riuniti Umberto I; Clinica di Ematologia
  • Giovanni Paolo II/I.R.C.C.S. Istituto Tumori
  • Ospedale V. Cervello; U.O. Ematologia E Trapianti
  • Azienda Ospedaliera Universitaria Careggi
  • Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova
  • Aichi Cancer Center
  • National Cancer Center Hospital East
  • Hokkaido University Hospital
  • Kumamoto University Hospital
  • University Hospital Kyoto Prefectural University of Medicine
  • Mie University Hospital
  • Tohoku University Hospital
  • Okayama University Hospital
  • Osaka Metropolitan University Hospital
  • Kindai University Hospital
  • National Cancer Center Hospital
  • The Cancer Institute Hospital of JFCR
  • Pusan National University Hospital
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Seoul St Mary's HospitalRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Szpitale Pomorskie Sp. z o. o.; Oddzia? Hematologii i Transplantologii SzpikuRecruiting
  • Pratia Onkologia Katowice
  • Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
  • Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku
  • Instytut Hematologii i Transfuzjologii; Klinika HematologiiRecruiting
  • Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji SzpikuRecruiting
  • FSBI "National Medical Research Center of Oncology N.N. Blokhin?
  • City Clinical Botkin's Hospital; City Hematological Center
  • Regional Clinical Hospital N.A. Semashko; Hematology
  • Penza Regional Oncology DispensaryRecruiting
  • Hospital de Donostia; Servicio de Oncologia
  • Hospital Universitario la Paz; Servicio de Hematologia
  • Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología
  • Hospital Universitario Virgen del Rocio; Servicio de Hematologia
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
  • Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-OncologyRecruiting
  • Taipei Veterans General HospitalRecruiting
  • National Taiwan Universtiy Hospital; Division of Hematology
  • Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
  • Sanko University Faculty of Medicine
  • Gulhane Training and Research HospitalRecruiting
  • Hacettepe Uni Medical Faculty; Hematology
  • Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
  • Marmara Ün?Vers?Tes? ?Stanbul Pend?K E??T?M Ve Ara?Tirma Hastanes?
  • Erciyes Uni ; Hematology
  • Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
  • Karadeniz Technical Uni School of Medicine; Hematology
  • Municipal Noncommercial Institution Regional Center of Oncology
  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
  • Medical Center named after academician Yuri Prokopovich Spizhenko; Oncochemotherpy Department
  • Mykolayiv Regional Hospital
  • SIResearch Centre for Radiation Medicine of AMS of Ukraine; Department of Radiation Oncohematology
  • National Institute of Cancer
  • Royal Cornwall Hospitals NHS Trust
  • Gloucestershire Royal Hospital; Haematology Department
  • Royal Marsden Hospital - Fulham
  • Hammersmith Hospital; Dept of OncologyRecruiting
  • Nottingham City Hospital; Dept of Haematology
  • Royal Marsden Hospital; Dept of Medical Oncology
  • Torbay Hospital; OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

M + Len (Arm A)

R + Len (Arm B)

M + Len (US Extension Arm C)

Arm Description

Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)

Participants will receive weekly rituximab in Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11. Participants will also receive lenalidomide in Cycles 1-12. (Cycle length = 28 days for Cycles 1-12)

Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) according to 2014 Lugano Response Criteria

Secondary Outcome Measures

PFS as Determined by the Investigator
Complete Response Rate
Objective Response Rate (ORR)
Overall Survival (OS)
Duration of Objective Response (DOR)
Duration of Complete Reponse (DOCR)
Time to Deterioration in Physical Functioning and Fatigue, as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
Time to Deterioration in Lymphoma Symptoms, as Measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)
Percentage of Participants with Adverse Events (AEs)
Serum Concentration of M + Len
Area Under the Curve (AUC) of M + Len
Percentage of Participants with Anti-Drug Antibodies (ADAs)
Time to Next Anti-Lymphoma Treatment (TTNALT)

Full Information

First Posted
January 13, 2021
Last Updated
October 12, 2023
Sponsor
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT04712097
Brief Title
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
Acronym
Celestimo
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
August 25, 2025 (Anticipated)
Study Completion Date
May 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Follicular Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
474 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
M + Len (Arm A)
Arm Type
Experimental
Arm Description
Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)
Arm Title
R + Len (Arm B)
Arm Type
Experimental
Arm Description
Participants will receive weekly rituximab in Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11. Participants will also receive lenalidomide in Cycles 1-12. (Cycle length = 28 days for Cycles 1-12)
Arm Title
M + Len (US Extension Arm C)
Arm Type
Experimental
Arm Description
Participants will receive mosunetuzumab for 12 cycles, plus lenalidomide from cycles 2-12 (Cycle length = 21 days for Cycle 1; cycle length = 28 days for Cycles 2-12)
Intervention Type
Drug
Intervention Name(s)
Mosunetuzumab
Intervention Description
Participants will receive intravenous (IV) mosunetuzumab in a step-up dosing schedule on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-12
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Participants will receive oral lenalidomide once daily on Days 1-21 of Cycles 2-12 (M + Len) or Cycles 1-12 (R + Len)
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Participants will receive IV rituximab on Days 1, 8, 15, and 22 of Cycle 1, then on Day 1 of Cycles 3, 5, 7, 9, and 11
Intervention Type
Drug
Intervention Name(s)
Tociluzumab
Intervention Description
Tocilizumab will be administered as needed to manage cytokine release syndrome (CRS) events
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) according to 2014 Lugano Response Criteria
Time Frame
From randomization to the first occurrence of disease progression as determined by an independent review committee (IRC) or death from any cause (up to approximately 8 years)
Secondary Outcome Measure Information:
Title
PFS as Determined by the Investigator
Time Frame
From randomization to the first occurrence of disease progression or death from any cause (up to approximately 8 years)
Title
Complete Response Rate
Time Frame
Up to approximately 8 years
Title
Objective Response Rate (ORR)
Time Frame
Up to approximately 8 years
Title
Overall Survival (OS)
Time Frame
From randomization to death from any cause (up to approximately 8 years)
Title
Duration of Objective Response (DOR)
Time Frame
From the first occurrence of a documented objective response (complete response or partial response) to disease progression or death from any cause, whichever occurs first (up to approximately 8 years)
Title
Duration of Complete Reponse (DOCR)
Time Frame
From the first occurrence of a documented CR to disease progression or death from any cause, whichever occurs first (up to approximately 8 years)
Title
Time to Deterioration in Physical Functioning and Fatigue, as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30)
Time Frame
Up to approximately 8 years
Title
Time to Deterioration in Lymphoma Symptoms, as Measured by the Functional Assessment of Cancer Therapy-Lymphoma Subscale (FACT-LymS)
Time Frame
Up to approximately 8 years
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Up to approximately 8 years
Title
Serum Concentration of M + Len
Time Frame
Up to approximately 8 years
Title
Area Under the Curve (AUC) of M + Len
Time Frame
Up to approximately 8 years
Title
Percentage of Participants with Anti-Drug Antibodies (ADAs)
Time Frame
Up to approximately 8 years
Title
Time to Next Anti-Lymphoma Treatment (TTNALT)
Time Frame
From randomization to the first documented administration of a new anti-lymphoma treatment (up to approximately 8 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: Grade 3b FL History of transformation of indolent disease to diffuse-large B cell lymphoma Documented refractoriness to lenalidomide, defined as no response (partial response or complete response) or relapse within 6 months of therapy Active or history of CNS lymphoma or leptomeningeal infiltration 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, 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 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 erythema multiforme, Grade >/= 3 rash, or blistering following prior treatment with immunomodulatory derivatives History of interstitial lung disease, drug-induced pneumonitis, and autoimmune pneumonitis 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 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) 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 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 Prior allogeneic stem cell transplantation Contraindication to treatment for thromboembolism prophylaxis 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 Pregnant or lactating or intending to become pregnant during the study 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID: GO42909 https://forpatients.roche.com/
Phone
888-662-6728
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
cCare
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Withdrawn
Facility Name
Fort Wayne Medical Oncology and Hematology, Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins Uni ; Sidney Kimmel Comprehensive Care Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer & Hematology Center of West Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University; Wash Uni. Sch. Of Med
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center at Cooper
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Long Island Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Ambulatory Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Univ Health Svcs; Section on Hem and Onc
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336-7774
Country
United States
Individual Site Status
Recruiting
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Adelaide Hospital; Haematology Clinical Trials
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
Geelong Hospital; Andrew Love Cancer Centre
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Active, not recruiting
Facility Name
ICTR Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
80510-130
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Mae de Deus
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90110-000
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Alemao Oswaldo Cruz
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01323-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital
City
Beijing City
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Jilin University
City
Changchun City
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
City
Guangzhou City
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Name
The 1st Affiliated Hospital of Nanchang Unversity
City
Nanchang
ZIP/Postal Code
330019
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
ZIP/Postal Code
210008
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Fudan University Shanghai Cancer Center; Medical Oncology
City
Shanghai City
ZIP/Postal Code
201315
Country
China
Individual Site Status
Recruiting
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
City
Tianjin City
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Cancer Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430023
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan City
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xiamen University
City
Xiamen
ZIP/Postal Code
361003
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Zhejiang Cancer Hospital
City
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de La Cote Basque; Hematologie
City
Bayonne
ZIP/Postal Code
64109
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Ch De Chambery; Hematologie Oncologie
City
Chambery
ZIP/Postal Code
73011
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Henri Mondor; Hematologie Clinique
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Claude Huriez; Hematologie
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Saint Eloi; Service d'Hématologie Clinique
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU NANTES - Hôtel Dieu; Service d'Hematologie Clinique
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Antoine Lacassagne;B4 Hematologie Cancerologie
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Nîmes - Hôpital Carémeau
City
Nimes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Saint-Louis; Service d'Hématologie
City
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital Saint Antoine; Hematologie Clinique
City
Paris
ZIP/Postal Code
75571
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hopital De Haut Leveque; Hematologie Clinique
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Ch Lyon Sud; Hemato Secteur Jules Courmont
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital De La Miletrie; Hematologie Et Oncologie Medicale
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU de Reims
City
Reims
ZIP/Postal Code
51100
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Henri Becquerel; Service Hématologie
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Recruiting
Facility Name
ICLN;Hopital De Jour Rdc
City
St Priest En Jarez
ZIP/Postal Code
42271
Country
France
Individual Site Status
Active, not recruiting
Facility Name
ICANS
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinikum Augsburg; II. Med. Klinik
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Sozialstiftung Bamberg - Klinikum am Bruderwald, Med. Klinik V; Hämatologie und intern. Onkologie
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Vivantes Klinikum Am Urban Klinik für Innere Medizin Hämatologie und Onkologie
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Klinikum Chemnitz gGmbH, Klinik für Innere Medizin III, Hämatologie und Onkologie
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Individual Site Status
Withdrawn
Facility Name
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Marien-Hospital Klinik f.Hämatologie Onkologie u.Palliativmedizin
City
Düsseldorf
ZIP/Postal Code
40479
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Medizinische Klinik IV, Hämatologie Universitätsklinikum Gießen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Universitätsklinikum Halle; Klinik für Innere Medizin IV; Hämatologie und Onkologie
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
City
Homburg/Saar
ZIP/Postal Code
64421
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Westpfalz-Klinikum GmbH; Innere Medizin 1, Hämatologie und internistischen Onkologie
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Uni-Klinikum-Schleswig-Holstein; Klinik für Innere Medizin II; Hämatologie und Onkologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitaetsklinikum Schleswig Holstein - Campus Luebeck; Haematologie, Onkologie
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Klinik und Poliklinik f. Innere Medizin III des Universitätsklinikums Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Active, not recruiting
Facility Name
Universitätsklinik Rostock; Klinik für Innere Med. III, Abteilung Hämatologie/Onkologie
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universtitätsklinikum Ulm; Klinik für Innere Medizin III
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
U.O. Ematologia AUSL Ravenna
City
Ravenna
State/Province
Emilia-Romagna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Di Circolo E Fondazione Macchi; Ematologia
City
Varese
State/Province
Lombardia
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Ospedali Riuniti Umberto I; Clinica di Ematologia
City
Ancona
State/Province
Marche
ZIP/Postal Code
60100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Giovanni Paolo II/I.R.C.C.S. Istituto Tumori
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale V. Cervello; U.O. Ematologia E Trapianti
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90146
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Florence
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Aichi Cancer Center
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Center Hospital East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Hokkaido University Hospital
City
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Mie University Hospital
City
Mie
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Tohoku University Hospital
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Osaka Metropolitan University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Kindai University Hospital
City
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
National Cancer Center Hospital
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
The Cancer Institute Hospital of JFCR
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Active, not recruiting
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Active, not recruiting
Facility Name
Seoul St Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpitale Pomorskie Sp. z o. o.; Oddzia? Hematologii i Transplantologii Szpiku
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pratia Onkologia Katowice
City
Katowice
ZIP/Postal Code
40-519
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Oddzial Kliniczny Hematologii SPZOZ MSWiA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie
City
Olsztyn
ZIP/Postal Code
10-228
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku
City
Pozna?
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
Instytut Hematologii i Transfuzjologii; Klinika Hematologii
City
Warszawa
ZIP/Postal Code
02-776
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
City
Wroc?aw
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Recruiting
Facility Name
FSBI "National Medical Research Center of Oncology N.N. Blokhin?
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
City Clinical Botkin's Hospital; City Hematological Center
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Regional Clinical Hospital N.A. Semashko; Hematology
City
Nizhny Novgorod
State/Province
Niznij Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Penza Regional Oncology Dispensary
City
Penza
ZIP/Postal Code
440071
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Hospital de Donostia; Servicio de Oncologia
City
Guipuzcoa
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario la Paz; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Hematologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology
City
Kaoisung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan Universtiy Hospital; Division of Hematology
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Sanko University Faculty of Medicine
City
?eh?tkam?l
ZIP/Postal Code
27090
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Gulhane Training and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe Uni Medical Faculty; Hematology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Atakent Acibadem Private Hosptial Halkali Merkez Mh.,
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Marmara Ün?Vers?Tes? ?Stanbul Pend?K E??T?M Ve Ara?Tirma Hastanes?
City
Istanbul
Country
Turkey
Individual Site Status
Completed
Facility Name
Erciyes Uni ; Hematology
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Koc Universitesi (KU) Tip Fakultesi (Koc University School of Medicine)
City
Sariyer
ZIP/Postal Code
34450
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Karadeniz Technical Uni School of Medicine; Hematology
City
Trabzon
ZIP/Postal Code
61800
Country
Turkey
Individual Site Status
Completed
Facility Name
Municipal Noncommercial Institution Regional Center of Oncology
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61070
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
City
Zaporizhzhia
State/Province
Kharkiv Governorate
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Medical Center named after academician Yuri Prokopovich Spizhenko; Oncochemotherpy Department
City
Kapitanivka
State/Province
KIEV Governorate
ZIP/Postal Code
08111
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Mykolayiv Regional Hospital
City
Mykolaiv
State/Province
KIEV Governorate
ZIP/Postal Code
54058
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
SIResearch Centre for Radiation Medicine of AMS of Ukraine; Department of Radiation Oncohematology
City
Kiev
ZIP/Postal Code
03115
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
National Institute of Cancer
City
Kyiv
ZIP/Postal Code
03022
Country
Ukraine
Individual Site Status
Withdrawn
Facility Name
Royal Cornwall Hospitals NHS Trust
City
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Gloucestershire Royal Hospital; Haematology Department
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Marsden Hospital - Fulham
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Hammersmith Hospital; Dept of Oncology
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Nottingham City Hospital; Dept of Haematology
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Marsden Hospital; Dept of Medical Oncology
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Torbay Hospital; Oncology
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

We'll reach out to this number within 24 hrs