Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (EPCORE™ NHL-2)

April 2, 2024 updated by: Genmab

A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab (EPKINLY™) in combination with other standard of care (SOC) agents in participants with B-cell Non-Hodgkin Lymphoma (B-NHL).

The trial consists of 10 different treatment arms. Arm 9 (follicular lymphoma (FL)) is still open for enrolment of new patients, while the other arms have closed their recruitment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All participants in the trial will receive epcoritamab, as monotherapy or in combination. The following regimens will be investigated:

Arm 1: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in participants with previously untreated diffuse large B-cell lymphoma (DLBCL)
Arm 2: epcoritamab + rituximab and lenalidomide (R2) in participants with relapsed/refractory (R/R) FL
Arm 3: epcoritamab + rituximab and bendamustine (BR) in participants with previously untreated FL
Arm 4: epcoritamab + rituximab, cytarabine, dexamethasone, and oxaliplatin/ carboplatin (R-DHAX/C) in participants with R/R DLBCL eligible for autologous stem cell transplant (ASCT)
Arm 5: epcoritamab + gemcitabine and oxaliplatin (GemOx) in participants with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity
Arm 6: epcoritamab + R2 in participants with previously untreated FL
Arm 7: epcoritamab maintenance in participants with FL who achieve a complete response (CR) or a partial response (PR) with SOC treatment
Arm 8: epcoritamab + reduced dose of R-CHOP (R mini-CHOP) in participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline
Arm 9: epcoritamab + lenalidomide for second-line treatment in participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy
Arm 10: epcoritamab + rituximab, ifosfamide, carboplatin, and etoposide phosphate (R-ICE) in participants with R/R DLBCL eligible for ASCT

The trial consists of two parts: Part 1 ('Dose Escalation') and Part 2 ('Dose Expansion'). The primary objective of Part 1 is safety, and it includes Arm 1-5 and Arm 10. Part 2 includes all 10 arms (Arm 1-10) and the primary goal of all arms, except Arm 7, is preliminary efficacy. For Arm 7, the primary goal is safety. Patients in Arm 1-5 and Arm 10 can only participate in either Part 1 or Part 2. Dose Limiting Toxicities (DLTs) will be assessed in Part 1 and for a selected number of patients in Arm 8 during a 28-day period ('safety-run phase'). The arms are conducted in parallel.

Study Type

Interventional

Enrollment (Estimated)

662

Phase

Phase 2
Phase 1

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Genmab A/S Trial Information
Phone Number: +45 70202728
Email: clinicaltrials@genmab.com

Study Locations

Australia
- - Heidelberg, Australia, VIC 3084
    - Recruiting
    - Austin Health
  - Nedlands, Australia, 6009
    - Recruiting
    - Linear Clinical Research Limited
- Victoria
  - Clayton, Victoria, Australia, 3084
    - Completed
    - Monash Medical Centre
Belgium
- - Brugge, Belgium, 8000
    - Recruiting
    - AZ Sint-Jan
  - Gent, Belgium, 9000
    - Recruiting
    - Universitair Ziekenhuis Gent
  - Yvoir, Belgium, 5530
    - Recruiting
    - CHU UCL Namur site Godinne
Czechia
- - Hradec Králové, Czechia
    - Recruiting
    - Fakultni nemocnice Hradec Kralove
  - Ostrava - Poruba, Czechia
    - Recruiting
    - Fakultni Nemocnice Ostrava
  - Prague, Czechia, 15006
    - Recruiting
    - Fakultni Nemocnice V Motole
  - Praha 2, Czechia
    - Recruiting
    - Vseobecna Fakultni Nemocnice
Denmark
- - Arhus, Denmark
    - Recruiting
    - Århus Hospital
  - Copenhagen, Denmark, 2100
    - Recruiting
    - Rigshospitalet
  - Odense, Denmark
    - Recruiting
    - Odense University Hospital
  - Vejle, Denmark
    - Recruiting
    - Vejle Sygehus
Finland
- - Helsinki, Finland, 33520
    - Recruiting
    - Tampere university Hospital
  - Kuopio, Finland, 70210
    - Recruiting
    - Kuopio University Hospital
  - Lahti, Finland, 15850
    - Recruiting
    - HUS Cancer Center
France
- - Bordeaux, France, 33076
    - Recruiting
    - Institut Bergonié
  - Dijon, France, 21000
    - Recruiting
    - CHU Dijon - Hopital du Bocage
  - Lille, France, 59037
    - Recruiting
    - Hopital Claude Huriez - CHRU Lille
  - Marseille, France, 13005
    - Recruiting
    - hopital de la Timone
  - Paris, France, 75475
    - Recruiting
    - Hôpital Saint-Louis
  - Pierre-Bénite, France, 69495
    - Recruiting
    - Centre Hospitalier Lyon Sud
Italy
- - Bergamo, Italy, 24127
    - Recruiting
    - Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
  - Bologna, Italy
    - Recruiting
    - Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
  - Candiolo, Italy, 10060
    - Recruiting
    - Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS
  - Meldola, Italy, 47014
    - Recruiting
    - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  - Milan, Italy, 20122
    - Recruiting
    - Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
  - Pavia, Italy, 27100
    - Recruiting
    - Fondazione IRCCS Policlinico San Matteo
  - Reggio Emilia, Italy, 42123
    - Recruiting
    - Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Recruiting
    - Amsterdam UMC, Locatie VUMC
  - Groningen, Netherlands, 9713
    - Recruiting
    - Universitair Medisch Centrum Groningen (Umcg)
  - Leiden, Netherlands, 2333 ZA
    - Recruiting
    - Leids Universitair Medisch Centrum
  - Maastricht, Netherlands, 6229 HX
    - Recruiting
    - Maastricht University Medical Center
  - Rotterdam, Netherlands
    - Recruiting
    - Erasmus Medisch Centrum
  - Utrecht, Netherlands, 3584
    - Recruiting
    - UMC Utrecht
Norway
- - Oslo, Norway, 310
    - Recruiting
    - Oslo Universitetssykehus HF, Radiumhospitalet
Spain
- - Barcelona, Spain, 8035
    - Recruiting
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spain, 08908
    - Recruiting
    - ICO l Hospitalet
  - Madrid, Spain, 28046
    - Recruiting
    - Hospital Universitario La Paz
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Universitario Fundacion Jimenez Diaz
  - Salamanca, Spain, 37007
    - Recruiting
    - Hospital Universitario de Salamanca
Sweden
- - Borås, Sweden
    - Recruiting
    - Södra Älvsborgs Sjukhus
  - Göteborg, Sweden, 413 45
    - Recruiting
    - Sahlgrenska Sjukhuset
  - Lund, Sweden
    - Recruiting
    - Skanes universitetssjukhus
  - Solna, Sweden
    - Recruiting
    - Karolinska Universitetssjukhuset
  - Umeå, Sweden
    - Recruiting
    - Norrlands universitetssjukhus
  - Uppsala, Sweden
    - Recruiting
    - Akademiska Sjukhuset
United Kingdom
- - London, United Kingdom, NW1 2PG
    - Completed
    - University College London Hospitals
  - Manchester, United Kingdom
    - Recruiting
    - The Christie NHS Foundation Trust
  - Newcastle Upon Tyne, United Kingdom, NE7 7D
    - Recruiting
    - Freeman Hospital
  - Plymouth, United Kingdom, PL6 8DH
    - Recruiting
    - Derriford Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - Recruiting
    - University of Alabama at Birmingham
- California
  - Los Angeles, California, United States, 90048
    - Recruiting
    - Cedars-Sinai Medical Center
  - Los Angeles, California, United States, 90095
    - Recruiting
    - David Geffen School of Medicine at UCLA
  - San Francisco, California, United States, 94143
    - Recruiting
    - University of California San Francisco
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Recruiting
    - Dana Farber Cancer Institute
- Michigan
  - Ann Arbor, Michigan, United States, 84109
    - Recruiting
    - University of Michigan Comprehensive Cancer Center
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - John Theurer Cancer Center at Hackensack UMC
- New York
  - New York, New York, United States, 10029
    - Recruiting
    - Mount Sinai
  - New York, New York, United States, 10065
    - Recruiting
    - Memorial Sloan Kettering CC
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Recruiting
    - Levine Cancer Center
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15232
    - Withdrawn
    - UMPC Hillman Cancer Center Cancer Pavillion
- Texas
  - Dallas, Texas, United States, 75390
    - Recruiting
    - UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Key Inclusion Criteria

Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI)
Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
Acceptable organ function at screening
CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
If of childbearing potential subject must practicing a highly effective method of birth control
A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control

Arm 1:

Newly Diagnosed Documented diffuse large B-cell lymphoma (DLBCL)
DLBCL, NOS
"double-hit" or "triple-hit" DLBCL
FL Grade 3B

Arm 2: R/R FL

Arm 3: Newly diagnosed, previously untreated FL grade 1-3A

Arm 4:

Documented DLBCL and eligible for HDT-ASCT
DLBCL, NOS
"double-hit" or "triple-hit" DLBCL
FL Grade 3B

Arm 5:

Relapsed or refractory documented DLBCL and ineligible for HDT-ASCT
DLBCL, NOS
"double-hit" or "triple-hit" DLBCL
FL Grade 3B

Arm 6: Newly diagnosed, previously untreated FL grade 1-3A

Arm 7:

FL Grade 1-3A
If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment.

Arm 8:

DLBCL, NOS
T-cell/histiocyte rich DLBCL
"double-hit" or "triple-hit" DLBCL
FL Grade 3B

Arm 9:

R/R FL
Progressed within 24 months of initiating first-line treatment

Arm 10:

Documented DLBCL and eligible for HDT-ASCT
DLBCL, NOS
"double-hit" or "triple-hit" DLBCL
FL Grade 3B

Key Exclusion Criteria

Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
Any prior treatment with a bispecific antibody targeting CD3 and CD20.
Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab
Clinically significant cardiovascular disease
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
Active positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
Known history of seropositivity of human immunodeficiency virus (HIV)
Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
Neuropathy > grade 1
Receiving immunostimulatory agent
Prior allogeneic HSCT
Current seizure disorder requiring anti-epileptic therapy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - Epcoritamab + R-CHOP In participants with previously untreated DLBCL.	Drug: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone 21-day cycles Other Names: R-CHOP 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™
Experimental: Arm 2 - Epcoritamab + R2 In participants with R/R FL.	Drug: rituximab and lenalidomide 28-day cycles Other Names: R2 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™
Experimental: Arm 3 - Epcoritamab + BR In participants with previously untreated FL.	Drug: rituximab and bendamustine 28-day cycles Other Names: BR 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™
Experimental: Arm 4 - Epcoritamab + R-DHAX/C In participants with R/R DLBCL eligible for ASCT.	Drug: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin 21-day cycles Other Names: R-DHAX/C 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™
Experimental: Arm 5 - Epcoritamab + GemOx In participants with R/R DLBCL ineligible ASCT.	Drug: gemcitabine and oxaliplatin 28-day cycles Other Names: GemOx 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™
Experimental: Arm 6 - Epcoritamab + R2 In participants with previously untreated FL.	Drug: rituximab and lenalidomide 28-day cycles Other Names: R2 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™
Experimental: Arm 7 - Epcoritamab maintenance In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L.	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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™
Experimental: Arm 8 - Epcoritamab + R mini-CHOP In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline.	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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Drug: rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone 21-day cycles Other Names: R mini-CHOP
Experimental: Arm 9 - Epcoritamab + Lenalidomide In participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy.	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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Drug: Lenalidomide 28-day cycles
Experimental: Arm 10 - Epcoritamab + R-ICE In participants with R/R DLBCL eligible for ASCT.	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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1 and then every 8 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ 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. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-3 and then every 4 weeks for a total of 2 years. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Biological: Epcoritamab Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression. Other Names: GEN3013 DuoBody®-CD3xCD20 EPKINLY™ Drug: rituximab, ifosfamide, carboplatin, and etoposide phosphate 21-day cycles Other Names: R-ICE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of Participants With Dose limiting Toxicities (DLTs) Time Frame: During the first cycle (Cycle length= 28 days) in each cohort	DLT events are defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.	During the first cycle (Cycle length= 28 days) in each cohort
Part 1 and Part 2 (Arm 7): Number of Participants With Adverse Events (AEs) Time Frame: From first dose of trial medication to the maximum of 60 days after last dose of epcoritamab or initiation of subsequent anti-lymphoma therapy.	An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign. (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.	From first dose of trial medication to the maximum of 60 days after last dose of epcoritamab or initiation of subsequent anti-lymphoma therapy.
Part 2 (Except Arm 7): Overall Response Rate (ORR) Time Frame: Up to 3 years	ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 and 2: Clearance (CL) of Epcoritamab Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)		Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Volume of Distribution (Vd) of Epcoritamab Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)		Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Last Quantifiable Dose (AUC0-last) of Epcoritamab Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)		Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Epcoritamab Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)		Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Maximum (Peak) Plasma Concentration (Cmax) of Epcoritamab Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)		Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Time to Reach Cmax (Tmax) of Epcoritamab Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)		Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Terminal Elimination Half-Life (t 1/2) of Epcoritamab Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)		Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Plasma Trough (Pre-dose) Concentrations (Ctrough) of Epcoritamab Time Frame: Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)		Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Part 1 and 2: Number of Immune Cell Populations Time Frame: Up to 2 years	Immune cell populations in peripheral blood and tumor biopsies will be assessed.	Up to 2 years
Part 1 and 2: Percentage of Immune Cell Populations Time Frame: Up to 2 years	Immune cell populations in peripheral blood and tumor biopsies will be assessed.	Up to 2 years
Part 1 and 2: Change From Baseline in Cytokine Levels up to Cycle 3 Time Frame: Up to Cycle 3 (cycle length = 21 days for Arms 1, 4, 8 and 10; cycle length = 28 days for Arms 2, 3, 5, 6 and 9; cycle length = 28 days (Cycle 1) and 56 days (Cycles 2, 3) for Arm 7)	Change in cytokine levels in peripheral blood samples will be assessed.	Up to Cycle 3 (cycle length = 21 days for Arms 1, 4, 8 and 10; cycle length = 28 days for Arms 2, 3, 5, 6 and 9; cycle length = 28 days (Cycle 1) and 56 days (Cycles 2, 3) for Arm 7)
Part 1 and 2: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (DNA) Level up to End of Treatment (up to 2 Years) Time Frame: Up to 2 years	Change in circulating tumor DNA levels will be assessed.	Up to 2 years
Part 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Epcoritamab Time Frame: Up to 3 years		Up to 3 years
Part 1: ORR Time Frame: Up to 3 years	ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria.	Up to 3 years
Part 1 and 2: Duration of Response (DOR) Time Frame: Up to 3 years	DOR: the time from the first documentation of objective tumor response (CR or PR) to the date of first PD or death based on Lugano criteria.	Up to 3 years
Part 1 and 2: Time to Response (TTR) Time Frame: Up to 3 years	TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (CR or PR).	Up to 3 years
Part 1 and 2: Progression Free Survival (PFS) Time Frame: Up to 3 years	PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause based on Lugano criteria.	Up to 3 years
Part 1 and 2: Overall Survival (OS) Time Frame: Up to 3 years	OS is defined as the time from the date of first dose, to the date of death due to any cause.	Up to 3 years
Part 1 and 2: Time to Next Anti-lymphoma Therapy (TTNT) Time Frame: Up to 3 years	TTNT is defined as the time from Day 1 of Cycle 1 to first documented administration of subsequent anti-lymphoma therapy.	Up to 3 years
Part 1 and 2: Percentage of Participants With Minimal Residual Disease (MRD) Negativity Time Frame: Up to 3 years	It is defined as the percentage of participants with at least 1 MRD negative result.	Up to 3 years
Part 1 and 2: Duration of minimal residual disease (MRD) negativity Time Frame: Up to 3 years		Up to 3 years
Part 2 (Arm 7): Percentage of Participants Who Converted From MRD Positivity to MRD Negativity Time Frame: Up to 3 years		Up to 3 years
Part 2 (Except Arm 7): Percentage of Participants with Complete Response (CR) in Arms 1 to 10 Time Frame: Up to 3 years		Up to 3 years
Part 2 (Arm 7): Percentage of Participants With CR Time Frame: Week 24, Week 48, and Week 96	It is defined as the percentage of participants who remain in complete remission or converting to complete remission after first trial drug administration.	Week 24, Week 48, and Week 96
Part 1 and 2: Time to Complete Response (TTCR) Time Frame: Up to 3 years	TTCR is defined as the time from first trial drug administration to the date of first documented complete response post-treatment.	Up to 3 years
Part 1 and 2: Duration of Complete Response (DoCR) Time Frame: Up to 3 years	DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs first based on Lugano criteria.	Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Collaborators

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Patient website: Recruiting clinical sites in Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2020

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

March 31, 2029

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

GCT3013-02
2020-000845-15 (EudraCT Number)
NL74222.056.20 (Registry Identifier: CCMO)
283235 (Other Identifier: IRAS ID; UK Research Summaries Database)
2023-504805-35-00 (Registry Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (EPCORE™ NHL-2)

A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Expanded Access

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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