Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

NCT06191744 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M22-0032023-506906-38-00
• Study Type: interventional
• Target: 1,095
• Locations: 31 countries
• Sites: 264

Brief Summary

Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with previously untreated FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world. Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Conditions

Follicular Lymphoma (FL)

Keywords

Follicular Lymphoma (FL); Non-Hodgkin's lymphoma (NHL); Lymphoma; Cancer; Epcoritamab; Rituximab; Lenalidomide; Chemoimmunotherapy (CIT); Obinutuzumab; Cyclophosphamide; Doxorubicin Hydrochloride; Vincristine Sulfate; Prednisone; Bendamustine (Benda); R-CHOP; G-CHOP; R-Benda; G-Benda; EPCORE™FL-2

Outcome Measures

Primary Outcomes (2)

• Arm A1 vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)

  CR30 will be determined by positron emission tomography-computerized tomography (cat scan) \[PET-CT\] per Lugano 2014 criteria, as assessed by independent review committee (IRC).

  Up to 30 Months

• Arm A1 vs Arm B: Number of Participants with Progression-free survival (PFS)

  PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.

  Up to 10 Years

Secondary Outcomes (94)

• Arm A1 vs Arm B: Overall Survival (OS)

  Up to 10 Years

• Arm A1 vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate

  Up to 10 Years

• Arm A1 vs Arm B: Change from Baseline in Physical Functioning (PF) According to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30)

  21 Weeks

• Arm A1 vs Arm A2: Percentage of Participants who Achieve CR30

  Up to 30 Months

• Arm A1 vs Arm C: Percentage of Participants who Achieve CR30

  Up to 30 Months

Study Arms (5)

Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2)

EXPERIMENTAL

Participants will receive epcoritamab in combination with R2 (ER2), followed by epcoritamab during the 120 week treatment duration.

Drug: Epcoritamab; Drug: Rituximab; Drug: Lenalidomide

Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2)

EXPERIMENTAL

Participants will receive epcoritamab in combination with R2 (ER2), during the 24 week treatment duration.

Drug: Epcoritamab; Drug: Rituximab; Drug: Lenalidomide

Arm B: Chemoimmunotherapy (CIT) Option A

EXPERIMENTAL

Participants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) \[G-CHOP\]/ rituximab (R)-CHOP during the 120 week treatment duration.

Drug: Prednisone; Drug: Rituximab; Drug: Doxorubicin; Drug: Vincristine; Drug: Cyclophosphamide; Drug: Obinutuzumab

Arm B: Chemoimmunotherapy (CIT) Option B

EXPERIMENTAL

Participants will receive CIT Option B (G and bendamustine (Benda) \[G-Benda\]/R-Benda during the 120 week treatment duration.

Drug: Prednisone; Drug: Rituximab; Drug: Obinutuzumab; Drug: Bendamustine

Arm C: Lenalidomide and Rituximab (R2)

EXPERIMENTAL

Participants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.

Drug: Rituximab; Drug: Lenalidomide

Interventions

Epcoritamab DRUG

Subcutaneous (SC) Injection

Also known as: ABBV-GMAB-3013, GEN3013, Epkinly

Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2); Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2)

Cyclophosphamide DRUG

IV Injection

Arm B: Chemoimmunotherapy (CIT) Option A

Prednisone DRUG

Oral Tablet

Arm B: Chemoimmunotherapy (CIT) Option A; Arm B: Chemoimmunotherapy (CIT) Option B

Rituximab DRUG

Intravenous (IV) Infusion

Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2); Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2); Arm B: Chemoimmunotherapy (CIT) Option A; Arm B: Chemoimmunotherapy (CIT) Option B; Arm C: Lenalidomide and Rituximab (R2)

Lenalidomide DRUG

Oral Capsule

Arm A1: Epcoritamab + Lenalidomide and Rituximab (R2); Arm A2: Epcoritamab + Lenalidomide and Rituximab (R2); Arm C: Lenalidomide and Rituximab (R2)

Doxorubicin DRUG

IV Injection

Arm B: Chemoimmunotherapy (CIT) Option A

Vincristine DRUG

IV Injection

Arm B: Chemoimmunotherapy (CIT) Option A

Obinutuzumab DRUG

IV Infusion

Arm B: Chemoimmunotherapy (CIT) Option A; Arm B: Chemoimmunotherapy (CIT) Option B

Bendamustine DRUG

IV Infusion

Arm B: Chemoimmunotherapy (CIT) Option B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of follicular lymphoma (FL).
• Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
• Are willing and able to comply with procedures required in the protocol.
• Must have stage, III, IV or II with bulky disease \>= 7cm).
• Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
• Has one or more target lesions:
• A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
• \>=1 measurable nodal lesion (long axis \>1.5cm) or \>=1 measurable extra-nodal lesion (long axis \>1.0 cm) on CT scan or MRI
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: \[Arm B\] at the discretion of the Investigator, and rituximab and lenalidomide (R2) \[Arm C\].
• Have laboratory values meeting the criteria in the protocol.

You may not qualify if:

• Had major surgery within 4 weeks prior to randomization.
• Have active cytomegalovirus (CMV) disease.

Sponsors & Collaborators

• Genmab: lead
• AbbVie: collaborator

Study Sites (266)

UCSF Fresno /ID# 264712

Fresno, California, 93701-2302, United States

RECRUITING

Scripps Mercy Hospital /ID# 265393

San Diego, California, 92103, United States

RECRUITING

Sansum Clinic Research /ID# 261596

Santa Barbara, California, 93105, United States

RECRUITING

Rocky Mountain Cancer Centers - Boulder /ID# 261203

Boulder, Colorado, 80303, United States

RECRUITING

Christiana Care Health Service /ID# 261207

Newark, Delaware, 19713, United States

RECRUITING

Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445

Jacksonville, Florida, 32256, United States

RECRUITING

Advent Health /ID# 261578

Orlando, Florida, 32803, United States

RECRUITING

Orlando Health Cancer Institute /ID# 260983

Orlando, Florida, 32806, United States

RECRUITING

Moffitt Cancer Center /ID# 259487

Tampa, Florida, 33612-9416, United States

RECRUITING

Beacon Cancer Care - Coeur d'Alene /ID# 260670

Coeur d'Alene, Idaho, 83814, United States

RECRUITING

Northwestern Medicine - Northwestern Memorial Hospital /ID# 259814

Chicago, Illinois, 60611, United States

RECRUITING

Cancer Care Specialists Of Central Illinois /ID# 272464

Decatur, Illinois, 62526, United States

RECRUITING

Loyola University /ID# 259462

Maywood, Illinois, 60153, United States

COMPLETED

Illinois Cancer Care, PC /ID# 261526

Peoria, Illinois, 61615, United States

RECRUITING

Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583

Fort Wayne, Indiana, 46804, United States

RECRUITING

University of Iowa Health Care /ID# 262132

Des Moines, Iowa, 50314-3017, United States

RECRUITING

University of Louisville Hospital /ID# 260544

Louisville, Kentucky, 40202, United States

RECRUITING

Norton Cancer Institute - St. Matthews /ID# 261076

Louisville, Kentucky, 40207, United States

RECRUITING

New England Cancer Specialists - Westbrook /ID# 260672

Westbrook, Maine, 04092, United States

RECRUITING

University of Maryland, Baltimore /ID# 259538

Baltimore, Maryland, 21201, United States

RECRUITING

Center for Cancer and Blood Disorders-American Oncology Partners of Maryland /ID# 259476

Bethesda, Maryland, 20817, United States

RECRUITING

St. Luke's Hospital - Chesterfield /ID# 260489

Chesterfield, Missouri, 63017, United States

RECRUITING

Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 260006

Billings, Montana, 59102, United States

RECRUITING

Nebraska Cancer Specialists (NCS) - Regional Cancer Center - St Francis Location /ID# 262506

Grand Island, Nebraska, 68803, United States

RECRUITING

NHO - Nebraska Hematology-Oncology /ID# 269692

Lincoln, Nebraska, 68506, United States

RECRUITING

Nebraska Cancer Specialists - Omaha - Wright Street /ID# 262505

Omaha, Nebraska, 68130, United States

RECRUITING

University of Nebraska Medical Center /ID# 261996

Omaha, Nebraska, 68198, United States

RECRUITING

University of New Mexico /ID# 261083

Albuquerque, New Mexico, 87102-4517, United States

RECRUITING

Presbyterian Kaseman Hospital /ID# 262451

Albuquerque, New Mexico, 87110, United States

RECRUITING

Presbyterian Rust Medical Center /ID# 262447

Rio Rancho, New Mexico, 87124, United States

RECRUITING

New York Oncology Hematology - Albany Cancer Center /ID# 261814

Albany, New York, 12206-5013, United States

COMPLETED

NYU Langone Hospital - Long Island /ID# 265531

Mineola, New York, 11501, United States

RECRUITING

NYU Langone Medical Center /ID# 264518

New York, New York, 10016-6402, United States

RECRUITING

Icahn School of Medicine at Mount Sinai /ID# 259595

New York, New York, 10029, United States

RECRUITING

New York Oncology Hematology /ID# 270208

Troy, New York, 12180, United States

RECRUITING

Clinical Research Alliance - Westbury /ID# 261078

Westbury, New York, 11590, United States

RECRUITING

Novant Health Presbyterian Medical Center /ID# 259740

Charlotte, North Carolina, 28204, United States

RECRUITING

Novant Health Forsyth Medical Center /ID# 259741

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Oncology Hematology Care, Inc - Blue Ash /ID# 261204

Cincinnati, Ohio, 45252, United States

RECRUITING

Taylor Cancer Research Center /ID# 260488

Maumee, Ohio, 43537-1921, United States

COMPLETED

Oncology Associates of Oregon, P.C. /ID# 261816

Eugene, Oregon, 97401, United States

RECRUITING

MUSC Hollings Cancer Center /ID# 259604

Charleston, South Carolina, 29425, United States

RECRUITING

Prisma Health /ID# 259602

Greenville, South Carolina, 29605, United States

RECRUITING

Sarah Cannon Research Institute - Tristar Centennial Medical Center /ID# 274985

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Austin Midtown /ID# 261208

Austin, Texas, 78705, United States

RECRUITING

Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 261206

Dallas, Texas, 75246-2003, United States

RECRUITING

MD Anderson Cancer Center /ID# 260984

Houston, Texas, 77030-4000, United States

RECRUITING

Oncology Consultants /ID# 268390

Houston, Texas, 77030, United States

RECRUITING

Joe Arrington Cancer Research /ID# 260382

Lubbock, Texas, 79410, United States

RECRUITING

Intermountain Healthcare LDS Hospital /ID# 259759

Salt Lake City, Utah, 84143, United States

RECRUITING

Virginia Cancer Specialists - Fairfax /ID# 261205

Fairfax, Virginia, 22031, United States

RECRUITING

Oncology and Hematology Associates of Southwest Virginia /ID# 261592

Roanoke, Virginia, 98684, United States

RECRUITING

Swedish Cancer Institute - Edmonds /ID# 266356

Edmonds, Washington, 98026, United States

RECRUITING

Swedish Cancer Institute - Issaquah /ID# 266358

Issaquah, Washington, 98029, United States

RECRUITING

Vista Oncology - East Olympia /ID# 261360

Olympia, Washington, 98506-5028, United States

RECRUITING

Virginia Mason Hospital & Medical Center /ID# 260549

Seattle, Washington, 98101, United States

RECRUITING

Swedish Medical Center - Seattle /ID# 260370

Seattle, Washington, 98104, United States

RECRUITING

Northwest Medical Specialties - Tacoma /ID# 262133

Tacoma, Washington, 98405, United States

RECRUITING

Royal Prince Alfred Hospital /ID# 259320

Camperdown, New South Wales, 2050, Australia

RECRUITING

Liverpool Hospital /ID# 259321

Liverpool, New South Wales, 2170, Australia

RECRUITING

Peter MacCallum Cancer Center /ID# 260431

Melbourne, New South Wales, 3000, Australia

RECRUITING

Westmead Hospital /ID# 261465

Westmead, New South Wales, 2145, Australia

RECRUITING

Townsville University Hospital /ID# 259323

Douglas, Queensland, 4814, Australia

RECRUITING

Royal Brisbane and Women's Hospital /ID# 259326

Herston, Queensland, 4029, Australia

RECRUITING

Princess Alexandra Hospital - Woolloongabba /ID# 259329

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Peninsula Private Hospital /ID# 259325

Frankston, Victoria, 3199, Australia

RECRUITING

Fiona Stanley Hospital /ID# 259324

Murdoch, Western Australia, 6150, Australia

RECRUITING

Royal Perth Hospital /ID# 259319

Perth, Western Australia, 6000, Australia

RECRUITING

Algemeen Ziekenhuis klina /ID# 260324

Brasschaat, Antwerpen, 2930, Belgium

RECRUITING

Uza /Id# 260319

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Cliniques Universitaires UCL Saint-Luc /ID# 260311

Brussels, Brussels Capital, 1200, Belgium

RECRUITING

Groupe Sante CHC - Clinique du MontLegia /ID# 260325

Liège, Liege, 4000, Belgium

COMPLETED

UZ Gent /ID# 260312

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Leuven /ID# 260304

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

AZ-Delta. /ID# 260313

Roeselare, West-Vlaanderen, 8800, Belgium

RECRUITING

DF Star /ID# 260844

Brasília, Federal District, 70390-140, Brazil

RECRUITING

Oncocentro de Minas Gerais /ID# 260973

Belo Horizonte, Minas Gerais, 30360-680, Brazil

RECRUITING

Hospital Erasto Gaertner /ID# 260871

Curitiba, Puerto Rico, 81520-060, Brazil

RECRUITING

Hospital Amaral Carvalho - Fundacao Doutor Amaral Carvalho /ID# 260828

Jaú, São Paulo, 17210-070, Brazil

RECRUITING

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto /ID# 260843

Ribeirão Preto, São Paulo, 14049-900, Brazil

RECRUITING

Fundacao Antonio Prudente - AC Camargo Cancer Center /ID# 260827

São Paulo, São Paulo, 01509-900, Brazil

RECRUITING

Grupo Oncoclínicas Botafogo /ID# 260870

Rio de Janeiro, 22250-905, Brazil

RECRUITING

Real e Benemérita Associação Portuguesa de Beneficência /ID# 260826

São Paulo, 01323-001, Brazil

RECRUITING

Instituto D'Or de Pesquisa e Ensino - Regional Sao Paulo /ID# 260829

São Paulo, 01401-002, Brazil

RECRUITING

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 260822

São Paulo, 05403-000, Brazil

RECRUITING

UMHAT Dr Georgi Stranski EAD /ID# 260763

Pleven, 5800, Bulgaria

COMPLETED

Acibadem City Clinic Tokuda University Hospital EAD /ID# 260685

Sofia, 1407, Bulgaria

COMPLETED

UMHAT Sveti Ivan Rilski /ID# 259277

Sofia, 1431, Bulgaria

COMPLETED

SHAT Hematologic Diseases /ID# 260457

Sofia, 1797, Bulgaria

RECRUITING

Victoria Hospital /ID# 260770

London, Ontario, N6A 4L6, Canada

RECRUITING

The Ottawa Hospital - General Campus /ID# 264470

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

CSSS Alphonse-Desjardins, CHAU de Levis /ID# 260527

Lévis, Quebec, G6V 3Z1, Canada

RECRUITING

Centre Hospitalier de l'Universite de Montreal (CHUM) /ID# 260617

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Disc_Royal Victoria Hospital / McGill University Health Centre /ID# 261075

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Peking University First Hospital /ID# 259816

Beijing, Beijing Municipality, 100034, China

COMPLETED

Peking University Third Hospital /ID# 259806

Beijing, Beijing Municipality, 100191, China

RECRUITING

The First Affiliated Hospital of Xiamen University /ID# 260014

Xiamen, Fujian, 361003, China

RECRUITING

Sun Yat-Sen University Cancer Center /ID# 260478

Guangzhou, Guangdong, 510060, China

RECRUITING

Guangdong Provincial Peoples Hospital /ID# 260446

Guangzhou, Guangdong, 510080, China

RECRUITING

Zhujiang Hospital of Southern Medical University /ID# 260558

Guangzhou, Guangdong, 510280, China

RECRUITING

Nanfang Hospital of Southern Medical University /ID# 260795

Guangzhou, Guangdong, 510515, China

RECRUITING

Shenzhen People's Hospital /ID# 260137

Shenzhen, Guangdong, 518020, China

RECRUITING

Affiliated Cancer Hospital of Guangxi Medical University /ID# 260537

Nanning, Guangxi, 530021, China

RECRUITING

People's Hospital of Henan Province /ID# 259619

Zhengzhou, Henan, 450003, China

RECRUITING

Henan Cancer Hospital /ID# 259618

Zhengzhou, Henan, 450008, China

RECRUITING

Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 259743

Wuhan, Hubei, 430048, China

RECRUITING

Hubei Cancer Hospital /ID# 260506

Wuhan, Hubei, 430079, China

RECRUITING

Hunan Cancer Hospital /ID# 260439

Changsha, Hunan, 410006, China

RECRUITING

The First Affiliated Hospital of Soochow University /ID# 260507

Suzhou, Jiangsu, 215006, China

RECRUITING

The First Affiliated Hospital of Nanchang University /ID# 260556

Nanchang, Jiangxi, 330006, China

RECRUITING

Jiangxi Provincial Cancer Hospital /ID# 260559

Nanchang, Jiangxi, 330029, China

COMPLETED

First Affiliated Hospital of China Medical University /ID# 260217

Shenyang, Liaoning, 110001, China

RECRUITING

Shandong Cancer Hospital /ID# 260808

Jinan, Shandong, 251601, China

RECRUITING

Fudan University Cancer Hospital /ID# 260564

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

West China Hospital, Sichuan University /ID# 260015

Chengdu, Sichuan, 610041, China

RECRUITING

Tianjin Cancer Hospital /ID# 259807

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 259616

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 260644

Ürümqi, Xinjiang, 830000, China

RECRUITING

Yunnan Cancer Hospital /ID# 260645

Kunming, Yunnan, 650118, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 259744

Hangzhou, Zhejiang, 310003, China

RECRUITING

Zhejiang Cancer hospital /ID# 259742

Hangzhou, Zhejiang, 310022, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University /ID# 260566

Wenzhou, Zhejiang, 325000, China

RECRUITING

Clinical Hospital Dubrava /ID# 260452

Zagreb, City of Zagreb, 10000, Croatia

COMPLETED

Klinicka bolnica Merkur /ID# 260393

Zagreb, City of Zagreb, 10000, Croatia

COMPLETED

Klinicki bolnicki centar Sestre milosrdnice /ID# 260456

Zagreb, City of Zagreb, 10000, Croatia

COMPLETED

Klinicki bolnicki centar Zagreb /ID# 260364

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Klinicki bolnicki centar Rijeka /ID# 260455

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

RECRUITING

Klinicki Bolnicki Centar (KBC) Split /ID# 260454

Split, Split-Dalmatia County, 21000, Croatia

RECRUITING

Zadar General Hospital /ID# 260837

Zadar, 23000, Croatia

COMPLETED

Fakultni Nemocnice Brno - Jihlavska /ID# 260571

Brno, Brno-mesto, 625 00, Czechia

RECRUITING

Fakultni nemocnice Hradec Kralove - Sokolska /ID# 260560

Hradec Králové, 500 05, Czechia

RECRUITING

Fakultni nemocnice Kralovske Vinohrady /ID# 260572

Prague, 100 34, Czechia

RECRUITING

Rigshospitalet /ID# 260779

Copenhagen Ø, Capital Region, 2100, Denmark

RECRUITING

Regionshospitalet Godstrup /ID# 260778

Herning, Central Jutland, 7400, Denmark

COMPLETED

Roskilde Sygehus /ID# 260780

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

Odense University Hospital /ID# 260777

Odense, Region Syddanmark, 5000, Denmark

RECRUITING

Vejle Sygehus /ID# 260781

Vejle, Region Syddanmark, 7100, Denmark

RECRUITING

CHU de CAEN - Hopital de la Cote de Nacre /ID# 260875

Caen, Calvados, 14033, France

RECRUITING

CHU Brest - Hopital de la Cavale Blanche /ID# 260601

Brest, Finistere, 29200, France

RECRUITING

Hopital Prive du Confluent /ID# 260596

Nantes, Loire-Atlantique, 44277, France

RECRUITING

Centre Hospitalier D'Avignon /ID# 260511

Avignon, Provence-Alpes-Côte d'Azur Region, 84000, France

RECRUITING

HCL - Hopital Lyon Sud /ID# 260508

Pierre-Bénite, Rhone, 69495, France

RECRUITING

Centre Hospitalier du Mans /ID# 260510

Le Mans, Sarthe, 72037, France

RECRUITING

CH Libourne - Hopital Robert Boulin /ID# 261478

Libourne, 33500, France

RECRUITING

Hopital Saint-Louis /ID# 260509

Paris, 75010, France

RECRUITING

Clinique Sainte-Anne /ID# 261528

Strasbourg, 67085, France

COMPLETED

Hopital Prive d'Antony /ID# 260598

Antony, Île-de-France Region, 92160, France

RECRUITING

Staedtisches Klinikum Karlsruhe /ID# 260348

Karlsruhe, Baden-Wurttemberg, 76133, Germany

RECRUITING

Universitaetsklinikum Frankfurt /ID# 260388

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Klinikum Kassel /ID# 260432

Kassel, Hesse, 34125, Germany

RECRUITING

St.-Antonius-Hospital /ID# 260520

Eschweiler, North Rhine-Westphalia, 52249, Germany

COMPLETED

Klinikum Ludwigshafen /ID# 260688

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

RECRUITING

Otto-von-Guericke-Universitaet /ID# 260425

Magdeburg, Saxony-Anhalt, 39120, Germany

RECRUITING

Olympion General Clinic /ID# 262395

Pátrai, Achaia, 26443, Greece

RECRUITING

General Hospital of Athens Laiko /ID# 259708

Athens, Attica, 11527, Greece

RECRUITING

University General Hospital Attikon /ID# 260855

Athens, Attica, 12462, Greece

RECRUITING

General University Hospital of Alexandroupolis /ID# 260858

Alexandroupoli, 68100, Greece

RECRUITING

General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 259709

Athens, 10676, Greece

RECRUITING

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 260051

Győr, Győr-Moson-Sopron, 9024, Hungary

COMPLETED

Tolna Varmegyei Balassa Janos Korhaz /ID# 260048

Szekszárd, Tolna County, 7100, Hungary

RECRUITING

Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz /ID# 260050

Szombathely, Vas County, 9700, Hungary

RECRUITING

Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 260049

Budapest, 1097, Hungary

COMPLETED

Orszagos Onkologiai Intezet /ID# 260052

Budapest, 1122, Hungary

RECRUITING

Meir Medical Center /ID# 259938

Kfar Saba, Central District, 4428164, Israel

RECRUITING

Rabin Medical Center. /ID# 268328

Petah Tikva, Central District, 4941492, Israel

RECRUITING

HaEmek Medical Center /ID# 259936

Afula, Haifa District, 1834111, Israel

RECRUITING

Hadassah /ID# 259935

Jerusalem, Jerusalem, 91120, Israel

RECRUITING

Soroka University Medical Center /ID# 259937

Beersheba, Southern District, 8443901, Israel

RECRUITING

The Chaim Sheba Medical Center /ID# 259934

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Tel Aviv Sourasky Medical Center /ID# 259933

Tel Aviv, Tel Aviv, 6423906, Israel

RECRUITING

IRCCS Istituto Clinico Humanitas /ID# 260887

Rozzano, Lombardy, 20089, Italy

RECRUITING

Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 260889

Candiolo, Torino, 10060, Italy

RECRUITING

IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 260886

Bologna, 40138, Italy

RECRUITING

AOU Policlinico G. Rodolico - San Marco /ID# 260890

Catania, 95123, Italy

RECRUITING

Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 260888

Palermo, 90146, Italy

RECRUITING

AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 260744

Reggio Emilia, 42122, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico /ID# 260891

Roma, 00128, Italy

RECRUITING

Fujita Health University Hospital /ID# 264679

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

Matsuyama Red Cross Hospital /ID# 266426

Matsuyama, Ehime, 790-8524, Japan

RECRUITING

University of Fukui Hospital /ID# 265680

Yoshida-gun, Fukui, 910-1104, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center /ID# 265960

Fukuoka, Fukuoka, 811-1395, Japan

RECRUITING

Kyushu University Hospital /ID# 267861

Fukuoka, Fukuoka, 812-8582, Japan

RECRUITING

Fukushima Medical University Hospital /ID# 264994

Fukushima, Fukushima, 960-1295, Japan

RECRUITING

Chugoku Central Hospital /ID# 266520

Fukuyama, Hiroshima, 720-0001, Japan

RECRUITING

Sapporo Medical University Hospital /ID# 265031

Sapporo, Hokkaido, 060-8543, Japan

RECRUITING

Kobe City Medical Center General Hospital /ID# 266379

Kobe, Hyōgo, 650-0047, Japan

COMPLETED

Hitachi General Hospital /ID# 265676

Hitachi-shi, Ibaraki, 317-0077, Japan

RECRUITING

Kitasato University Hospital /ID# 264675

Sagamihara-shi, Kanagawa, 252-0375, Japan

RECRUITING

Kanagawa Cancer Center /ID# 265497

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Okayama University Hospital /ID# 267135

Okayama, Okayama-ken, 700-8558, Japan

COMPLETED

Kansai Medical University Hospital /ID# 266019

Hirakata-shi, Osaka, 573-1191, Japan

RECRUITING

Kindai University Hospital /ID# 265038

Sakai-shi, Osaka, 590-0197, Japan

RECRUITING

Tokyo Metropolitan Komagome Hospital /ID# 267692

Bunkyo Ku, Tokyo, 113-8677, Japan

RECRUITING

The University of Tokyo Hospital /ID# 266422

Bunkyo-ku, Tokyo, 113-8654, Japan

RECRUITING

Yamaguchi University Hospital /ID# 265619

Ube, Yamaguchi, 755-8505, Japan

RECRUITING

University of Yamanashi Hospital /ID# 264677

Chuo-shi, Yamanashi, 409-3898, Japan

RECRUITING

Aomori Prefectural Central Hospital /ID# 265692

Aomori, 030-0913, Japan

RECRUITING

Chiba Cancer Center /ID# 267316

Chiba, 260-0801, Japan

COMPLETED

Bravis Ziekenhuis /ID# 259055

Roosendaal, North Brabant, 4708 AE, Netherlands

COMPLETED

Elisabeth Tweesteden Ziekenhuis /ID# 261239

Tilburg, North Brabant, 5022 GC, Netherlands

COMPLETED

Olvg /Id# 259543

Amsterdam, North Holland, 1091 AC, Netherlands

COMPLETED

Leids Universitair Medisch Centrum /ID# 259049

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Franciscus Gasthuis & Vlietland, Locatie Gasthuis /ID# 259052

Rotterdam, South Holland, 3045 PM, Netherlands

RECRUITING

HagaZiekenhuis /ID# 261220

The Hague, South Holland, 2545 AA, Netherlands

RECRUITING

St. Antonius Ziekenhuis /ID# 259053

Nieuwegein, Utrecht, 3435 CM, Netherlands

RECRUITING

Rijnstate /ID# 261219

Arnhem, 6815 AD, Netherlands

COMPLETED

Universitair Medisch Centrum Groningen /ID# 259051

Groningen, 9713 GZ, Netherlands

RECRUITING

Auckland City Hospital /ID# 259330

Grafton, Auckland, 1023, New Zealand

RECRUITING

North Shore Hospital /ID# 260824

Takapuna, Auckland, 0622, New Zealand

RECRUITING

Aidport sp z o.o. /ID# 267717

Poznan, Greater Poland Voivodeship, 60-175, Poland

RECRUITING

Pratia MCM Krakow /ID# 260075

Krakow, Lesser Poland Voivodeship, 30-727, Poland

RECRUITING

Narodowy Instytut Onkologii im. M. Sklodowskiej /ID# 260861

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopern /ID# 260633

Lodz, Łódź Voivodeship, 93-513, Poland

RECRUITING

Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 260170

Kielce, Świętokrzyskie Voivodeship, 25-734, Poland

RECRUITING

Fundacao Champalimaud /ID# 259652

Lisbon, Lisbon District, 1400-038, Portugal

RECRUITING

Unidade Local de Saude de Gaia/Espinho /ID# 259655

Vila Nova de Gaia, Porto District, 4434-502, Portugal

RECRUITING

Unidade Local de Saude de Santa Maria /ID# 259650

Lisbon, 1649-035, Portugal

RECRUITING

Instituto Portugues de Oncologia do Porto Francisco Gentil /ID# 259649

Porto, 4200-072, Portugal

RECRUITING

Pan American Center for Oncology Trials, LLC /ID# 260265

Rio Piedras, 00935, Puerto Rico

RECRUITING

Auxilio Mutuo Cancer Center /ID# 260262

San Juan, 00918, Puerto Rico

RECRUITING

Fundeni Clinical Institute /ID# 260296

Bucharest, Bucharest, 022328, Romania

RECRUITING

Institutul Oncologic Prof Dr. Ion Chiricuta Cluj Napoca /ID# 259704

Cluj-Napoca, Cluj, 400015, Romania

RECRUITING

Institutul Regional de Oncologie /ID# 259697

Iași, Iaşi, 700483, Romania

RECRUITING

Spitalul Clinic Coltea /ID# 259699

Bucharest, 030171, Romania

RECRUITING

Clinical Hospital Center Zvezdara /ID# 260900

Belgrade, Beograd, 11000, Serbia

RECRUITING

University Clinical Center Serbia /ID# 259271

Belgrade, Beograd, 11000, Serbia

RECRUITING

University Clinical Center Kragujevac /ID# 259274

Kragujevac, Sumadijski Okrug, 34000, Serbia

RECRUITING

Institute for Oncology of Vojvodina /ID# 260223

Kamenitz, Vojvodina, 21208, Serbia

RECRUITING

University Clinical Center Vojvodina /ID# 259272

Novi Sad, 21000, Serbia

RECRUITING

Narodny onkologicky ustav /ID# 260638

Bratislava, Bratislava Region, 833 10, Slovakia

RECRUITING

Univerzitna nemocnica Martin /ID# 260631

Martin, Žilina Region, 036 01, Slovakia

COMPLETED

Wits Clinical Research /ID# 260958

Johannesburg, Gauteng, 1864, South Africa

RECRUITING

Alberts Cellular Therapy /ID# 260514

Pretoria, Gauteng, 0044, South Africa

RECRUITING

Haemalife Inc. /ID# 260513

Kuils River, Western Cape, 7580, South Africa

RECRUITING

Seoul National University Bundang Hospital /ID# 260009

Seongnam-si, Gyeonggido, 13620, South Korea

RECRUITING

Seoul National University Hospital /ID# 260007

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Asan Medical Center /ID# 260010

Seoul, Seoul Teugbyeolsi, 05505, South Korea

RECRUITING

Samsung Medical Center /ID# 260008

Seoul, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Instituto Catalan de Oncologia (ICO) Badalona /ID# 260495

Badalona, Barcelona, 08916, Spain

RECRUITING

Institut Catala dOncologia (ICO) - LHospitalet /ID# 261439

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Universitario Marques de Valdecilla /ID# 260497

Santander, Cantabria, 39008, Spain

RECRUITING

Clinica Universidad de Navarra - Pamplona /ID# 260496

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario Vall de Hebron /ID# 260490

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona /ID# 260492

Barcelona, 08036, Spain

RECRUITING

Hospital Santa Creu i Sant Pau /ID# 260498

Barcelona, 08041, Spain

RECRUITING

Hospital San Pedro de Alcantara /ID# 260502

Cáceres, 10003, Spain

RECRUITING

CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 261512

Madrid, 28027, Spain

RECRUITING

MD Anderson Madrid /ID# 260500

Madrid, 28033, Spain

RECRUITING

Hospital Universitario de Salamanca /ID# 260491

Salamanca, 37711, Spain

RECRUITING

Sodra Alvsborgs sjukhus /ID# 261168

Borås, Västra Götaland County, 501 82, Sweden

COMPLETED

Sahlgrenska Universitetssjukhuset /ID# 266600

Gothenburg, Västra Götaland County, 41346, Sweden

COMPLETED

China Medical University Hospital /ID# 260357

Taichung, 40447, Taiwan

RECRUITING

Taichung Veterans General Hospital /ID# 260361

Taichung, 40705, Taiwan

RECRUITING

National Cheng Kung University Hospital /ID# 260363

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital /ID# 260341

Taipei, 100, Taiwan

RECRUITING

Istanbul Florence Nightingale Hospital /ID# 271291

Şişli, Istanbul, 34381, Turkey (Türkiye)

RECRUITING

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 259804

Istanbul, 34899, Turkey (Türkiye)

RECRUITING

Ege Universitesi Tip Fakultesi /ID# 259803

Izmir, 35100, Turkey (Türkiye)

RECRUITING

Kocaeli University Med Faculty /ID# 259717

Kocaeli, 41380, Turkey (Türkiye)

RECRUITING

Ondokuz Mayis Universitesi /ID# 259713

Samsun, 55139, Turkey (Türkiye)

RECRUITING

University Hospitals Plymouth NHS Trust /ID# 262671

Plymouth, Devon, PL6 8DH, United Kingdom

RECRUITING

Hammersmith Hospital /ID# 261124

London, England, W12 0HS, United Kingdom

RECRUITING

Queen Alexandra Hospital /ID# 269708

Portsmouth, Hampshire, PO6 3LY, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust /ID# 260466

Leeds, West Yorkshire, LS9 7TF, United Kingdom

RECRUITING

The Christie Hospital /ID# 260463

Manchester, M20 4BX, United Kingdom

RECRUITING

The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260792

Newcastle upon Tyne, NE3 3HD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms

Interventions

Prednisone; Rituximab; Lenalidomide; Doxorubicin; Vincristine; Cyclophosphamide; obinutuzumab; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Butyrates; Acids, Acyclic; Benzimidazoles

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 5, 2024
• Study Start: February 5, 2024
• Primary Completion (Estimated): November 1, 2037
• Study Completion (Estimated): November 1, 2037
• Last Updated: June 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

DK (5); IL (7); BR (10); FR (10); PR (2); AU (10); NL (9); DE (6); CA (5); BU (4); IT (7); US (58); GB (6); BE (7); CZ (3); TU (5); CR (7); GR (5); SE (5); SL (2); PL (5); JP (21); ES (11); ZA (3); CN (28); HU (5); KR (4); PT (4); NZ (2); TW (4); RO (4)