Non Hodgkin Lymphoma Clinical Trial

A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma

Summary

This study will assess the efficacy and safety of mosunetuzumab in combination with polatuzumab vedotin (M+P) in participants with relapsed or refractory (R/R) diffuse-large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, transformed follicular lymphoma (trFL) and FL Grade 3B (FL3B) in comparison with a commonly used regimen in this participant population, rituximab, gemcitabine and oxaliplatin (R-GemOx).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
CD20+ aggressive lymphoma as determined by the local hemopathology laboratory from the following diagnoses by 2016 World Health Organization classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS); high-grade B-cell lymphoma (NOS or double/triple hit); transformed follicular lymphoma; follicular lymphoma Grade 3b
Have disease relapsed or refractory to at least one prior systemic therapy for aggressive non-Hodgkin's lymphoma (aNHL)
Participants who have received only one prior line of therapy must be ineligible for autologous stem cell transplant (ASCT)
Measurable disease
Adequate hepatic, hematologic, and renal function
Estimated creatinine clearance (CrCl) ≥ 30 mL/min by Cockroft-Gault method or other institutional standard methods
Negative HIV test at screening. Participants with a positive HIV test at screening are eligible provided that, prior to enrollment, they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count of at least 200 microliters, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months

Exclusion Criteria:

Pregnant or breast feeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 9 months after the final dose of polatuzumab vedotin, 12 months after the final dose of rituximab, 6 months after the final dose of gemcitabine, 9 months after the final dose of oxaliplatin, and 3 months after the final dose of tocilizumab, as applicable
Inability to comply with protocol-mandated activity restrictions
Prior treatment with mosunetuzumab or other CD-20-directed bispecific antibodies, or R-GemOx or Gem-Ox
Prior treatment with polatuzumab vedotin, with the following exceptions: participants who have a documented response (partial response or complete response) to polatuzumab vedotin and an absence of PD within 12 months from the last dose of polatuzumab vedotin; participants who received up to 2 doses of a polatuzumab vedotin-containing regimen as bridging to CAR-T therapy, and either has a documented disease control (stable disease, partial response, or complete response), or were not assessed for response following treatment with polatuzumab vedotin
Contraindication to any component of the study treatment
Grade > 1 peripheral neuropathy
Participants with Grade > 1 persistent toxicity related to prior anti-lymphoma treatment (except for alopecia and anorexia, or other toxicities not considered a safety risk for the participant per investigator's judgment)
Received anti-lymphoma treatments with monoclonal antibodies, radio-immunoconjugates or antibody-drug conjugates (ADCs) within 4 weeks before the first dose of study treatment
Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of study treatment
Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment
ASCT within 100 days prior to the first study treatment administration
Prior treatment with chimeric antigen receptor (CAR) T cell therapy within 30 days before the first study treatment administration
Prior allogenic stem cell transplant (SCT)
Have had a solid organ transplantation
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
History of confirmed progressive multifocal leukoencephalopathy
History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombination antibody-related fusion proteins)
History of other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of malignancies with a negligible risk of metastasis or death
Currently have or have had a past history of central nervous system (CNS) involvement of lymphoma
Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator, or with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications, are allowed
Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina
Significant active pulmonary disease
Participants with active symptoms of interstitial lung disease and/or pneumonitis, or those with a history of interstitial lung disease and/or pneumonitis within 6 months prior to the first dose of study treatment
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of the nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to the first study treatment administration
Known or suspected chronic active Epstein-Barr virus (EBV) infection
Recent major surgery within 4 weeks prior to the first study treatment administration
Positive test results for chronic hepatitis B infection
Acute or chronic hepatitis C virus (HCV) infection
Have been administered a live, attenuated vaccine within 4 weeks before the first dose of study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
Participants who have positive SARS-CoV-2 test within 7 days prior to enrollment (rapid antigen test result is acceptable)
History of autoimmune disease
Received investigational therapy, whether or not intended for lymphoma treatment, within 7 days prior to initiation of study treatment
Clinically significant history of liver disease, including viral or other hepatitis, or cirrhosis

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

222

Study ID:

NCT05171647

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 71 Locations for this study

See Locations Near You

Alaska Oncology & Hematology, LLC
Anchorage Alaska, 99508, United States
City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics
Duarte California, 91010, United States
Kaiser Permanente - Irvine
Irvine California, 92618, United States
Cancer Blood and Specialty Clinic
Los Alamitos California, 90720, United States
USC School of Medicine
Los Angeles California, 90033, United States
University of Miami - Clinical Research Services
Miami Florida, 33136, United States
Investigative Clinical Research of Indiana, LLC
Noblesville Indiana, 46062, United States
St. Luke's Hospital
Chesterfield Missouri, 63017, United States
Levine Cancer Institute - Clincal Trials Administration
Charlotte North Carolina, 28204, United States
Rhode Island Hospital; Comprehensive Cancer Center
Providence Rhode Island, 02903, United States
Ascension Seton Infusion Center
Austin Texas, 78712, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Instituto Alexander Fleming
Buenos Aires , 1426, Argentina
Fundaleu; Haematology
Buenos Aires , C1114, Argentina
Hospital Aleman
Ciudad Autonoma Buenos Aires , C1118, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires , C1181, Argentina
Hospital Erasto Gaertner
Curitiba PR, 81520, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre RS, 90035, Brazil
Hospital das Clínicas FMRP-USP
Ribeirao Preto SP, 14048, Brazil
Hospital Sao Jose
Sao Paulo SP, 01321, Brazil
D'or Instituto de Pesquisa e Educação
Sao Paulo SP, 04062, Brazil
Hamilton Health Sciences - Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
Princess Margaret Hospital; Department of Med Oncology
Toronto Ontario, M5G 2, Canada
Chum Hopital Notre Dame; Centre D'Oncologie
Montreal Quebec, H2L 4, Canada
Saskatchewan Cancer Agency (SCA) - Saskatoon Cancer Centre (SCC)
Saskatoon Saskatchewan, S7N 4, Canada
Sichuan Cancer Hospital
Chengdu City , 61004, China
Fujian Medical University Union Hospital
Fuzhou City , 35000, China
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology
Guangzhou City , 51006, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou , 31000, China
The Second Affiliated Hospital to Nanchang University
Nanchang , 33000, China
Tianjin Cancer Hospital
Tianjin , 30006, China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan , 43003, China
Henan Cancer Hospital
Zhengzhou , 45000, China
Soroka Medical Center; Hematology Deptartment
Beer Sheva , 84101, Israel
Meir Medical Center; Heamatology Dept
Kfar Saba , 44281, Israel
Ichilov Sourasky Medical Center; Heamatology
Tel Aviv , 64239, Israel
Kyushu University Hospital
Fukuoka , 812-8, Japan
Hokkaido University Hospital
Hokkaido , 060-8, Japan
Kobe City Medical Center General Hospital
Hyogo , 650-0, Japan
Tokai University Hospital
Kanagawa , 259-1, Japan
Mie University Hospital
Mie , 514-8, Japan
Tohoku University Hospital
Miyagi , 980-8, Japan
Kindai University Hospital
Osaka , 589-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Yamagata University Hospital
Yamagata , 990-9, Japan
Pusan National University Hospital
Busan , 602-7, Korea, Republic of
Chungnam National University Hospital
Daejeon , 35015, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Yeouido St. Mary's Hospital
Seoul , 07345, Korea, Republic of
Health Pharma Professional Research
Cdmx Mexico CITY (federal District), 03100, Mexico
Superare Centro de Infusion S.A. de C.V.
Mexico Mexico CITY (federal District), 06760, Mexico
Hospital Universitario Dr. Jose E. Gonzalez; Haematology
Monterrey Nuevo LEON, 64460, Mexico
Instituto Nacional de Cancerologia; Oncology
Mexico City , 14080, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico , , Mexico
Middlemore Clinical Trials
Auckland , , New Zealand
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
Arequipa , 5154, Peru
Hospital Nacional Edgardo Rebagliati Martins, Servicio de Gastroenterologia
Lima , 11, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima , 15038, Peru
Oncosalud Sac; Oncología
Lima , 41, Peru
Hospital De Alta Complejidad Virgen De La Puerta - Essalud; Oncology
Trujillo , 13013, Peru
Regional Clinical Hospital N.A. Semashko; Hematology
Nizhny Novgorod Niznij Novgorod, 60312, Russian Federation
Penza Regional Oncology Dispensary
Penza , 44007, Russian Federation
Chulalongkorn University Hospital; Hematology
Bangkok , 10330, Thailand
Siriraj Hospital; Division of Hematology, Department of Medicine
Bangkok , 10700, Thailand
Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine
Chiang Mai , 50200, Thailand
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
Khon Kaen , 40002, Thailand
Ankara University Medical Faculty
Ankara , 06100, Turkey
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul , 34214, Turkey
Anadolu Health Center; Heamathology Department
Kocaeli , 41400, Turkey
Dokuz Eylul Universitesi Tip Fakultesi
Lzmir , 35340, Turkey
Ondokuz Mayis Univ. Med. Fac.
Samsun , 55139, Turkey

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

222

Study ID:

NCT05171647

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.