Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

543

Participants

Timeline

Start Date

November 3, 2020

Primary Completion Date

September 30, 2028

Study Completion Date

September 30, 2028

Conditions
Diffuse Large B-Cell LymphomaFollicular Lymphoma
Interventions
DRUG

rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone

6 cycles (21-day cycles)

DRUG

rituximab and lenalidomide

rituximab 6 cycles and lenalidomide 12 cycles (28-day cycles)

DRUG

rituximab and bendamustine

6 cycles (28-day cycles)

DRUG

rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin

3 cycles (21-day cycles)

DRUG

gemcitabine and oxaliplatin

4 cycles (28-day cycles)

BIOLOGICAL

Epcoritamab

Every week in cycle 1-4, every 3 weeks in cycle 5 and 6, followed by every 4 weeks in cycle 7 for a total of 1 year.

DRUG

rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone

6 cycles (21-day cycles)

DRUG

Lenalidomide

12 cycles (28-day cycles)

DRUG

rituximab, ifosfamide, carboplatin, and etoposide phosphate

3 cycles (21-day cycles)

BIOLOGICAL

Epcoritamab

Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.

BIOLOGICAL

Epcoritamab

Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.

BIOLOGICAL

Epcoritamab

Every week in cycle 1 and then every 8 weeks for a total of 2 years.

BIOLOGICAL

Epcoritamab

Every week in cycles 1 and 2, then every 3 weeks in cycles 3 to 6 and then every 4 weeks for cycles 7 and 8.

BIOLOGICAL

Epcoritamab

Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.

BIOLOGICAL

Epcoritamab

Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until ASCT or disease progression.

BIOLOGICAL

Epcoritamab

"Eligible participants will receive subcutaneous (SC) epcoritamab in 28-day cycles. Fixed-treatment epcoritamab will be administered following a 2-Set Up Dosing regimen in Cycle 1. There will be 2 cohorts, 2a and 2b with different dosing schedules.~Cohort 2a will be dosed weekly (QW) in Cycles 1-3, once every 2 weeks (Q2W) in Cycles 4-9, and once every 4 weeks (Q4W) in Cycle 10 and beyond for up to 2 years.~In cohort 2b, an alternate dosing schedule for epcoritamab will be explored: epcoritamab administered QW for Cycles 1-2 only, then Q4W in Cycle 3 and beyond for up to 2 years."

DRUG

Rituximab and Lenalidomide

Rituximab 375 milligrams per meter squared (mg/m\^2) will be administered intravenously QW in Cycle 1 and Q4W in Cycles 2-5. Lenalidomide 20 mg will be administered orally daily for 21 days for 12 cycles.

BIOLOGICAL

Epcoritamab

Cycle 1-3 every week, every other week Cycle 4-9 and then Q4W until progression or unacceptable toxicity.

Trial Locations (57)

310

Oslo Universitetssykehus HF, Radiumhospitalet, Oslo

2100

Rigshospitalet, Copenhagen

3584

UMC Utrecht, Utrecht

5530

CHU UCL Namur Site Godinne, Yvoir

6009

Linear Clinical Research Limited, Nedlands

8000

AZ Sint-Jan, Bruges

8035

Hospital Universitari Vall d'Hebron, Barcelona

9000

Universitair Ziekenhuis Gent, Ghent

9713

Universitair Medisch Centrum Groningen (UMCG), Groningen

10029

Mount Sinai, New York

10060

Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS, Candiolo

10065

Memorial Sloan Kettering CC, New York

13005

Hôpital de la Timone, Marseille

15006

Fakultni nemocnice v Motole, Prague

15850

HUS Cancer Center, Lahti

20122

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milan

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII), Bergamo

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28040

Hospital Universitario Fundacion Jimenez Diaz, Madrid

28046

Hospital Universitario La Paz, Madrid

28204

Levine Cancer Center, Charlotte

35294

University of Alabama at Birmingham, Birmingham

37007

Hospital Universitario de Salamanca, Salamanca

42123

Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia, Reggio Emilia

47014

IRCCS Istituto Scientifico Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST, Meldola

48109

University of Michigan Comprehensive Cancer Center Michigan Medicine, Ann Arbor

59037

Hopital Claude Huriez - CHRU Lille, Lille

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70210

Kuopio University Hospital, Kuopio

75390

Southwestern Medical Center, Dallas

75475

Hôpital Saint-Louis, Paris

90048

Cedars-Sinai Medical Center, Los Angeles

90095

David Geffen School of Medicine at UCLA, Los Angeles

94143

University of California San Francisco, San Francisco

02215

Dana Farber Cancer Institute, Boston

07601

Hackensack University Medical Center, Hackensack

VIC 3084

Austin Health, Heidelberg

Unknown

Fakultni nemocnice Hradec Kralove, Hradec Králové

Fakultni nemocnice Ostrava, Ostrava - Poruba

Vseobecna Fakultni Nemocnice, Prague

Århus Hospital, Aarhus

Odense University Hospital, Odense

Vejle Sygehus, Vejle

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS, Bologna

Erasmus Medisch Centrum, Rotterdam

Södra Älvsborgs Sjukhus, Borås

Skånes Universitetssjukhus, Lund

Karolinska Universitetssjukhuset, Solna

Akademiska Sjukhuset, Uppsala

The Christie Hospital, Manchester

1105 AZ

Amsterdam UMC, Locatie VUMC, Amsterdam

2333 ZA

Leids Universitair Medisch Centrum, Leiden

6229 HX

Maastricht University Medical Center, Maastricht

08908

ICO l Hospitalet, Barcelona

413 45

Sahlgrenska Sjukhuset, Gothenburg

NE7 7D

Freeman Hospital, Newcastle upon Tyne

PL6 8DH

Derriford Hospital, Plymouth

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Genmab

INDUSTRY