Non Hodgkin Lymphoma Clinical Trial

A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Participants With Follicular Lymphoma and Marginal Zone Lymphoma

Summary

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called "relapsed"), or did not respond to treatment (called "refractory"). FL and MZL are subtypes of Non-Hodgkin 's lymphoma (NHL).

This study will be made up of two parts (Part 1 not randomized, Part 2 randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when used in combination with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how the combination of odronextamab and lenalidomide works compared to the combination of rituximab and lenalidomide, (the current standard-of-care treatment for FL and/or MZL). Standard-of-care means the usual medication expected and used when receiving treatment for a condition.

The study is looking at several other research questions, including:

What side effects may happen from taking the study drug in combination with lenalidomide
How much study drug is in your blood at different times
Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
The impact from the study drug on your quality-of-life and ability to complete routine daily activities

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra nodal MZL) as assessed by the investigator.
Must have refractory disease or relapsed after at least 2 cycles of prior systemic chemo-immunotherapy or immunotherapy. Prior systemic therapy should have included at least one anti-cluster of differentiation 20 (CD20) monoclonal antibody and patient should meet indication for treatment.
Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Adequate hematologic and organ function.

Key Exclusion Criteria:

Primary central nervous system (CNS) lymphoma or known involvement (either current or prior history of CNS involvement) by non-primary CNS NHL.
Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma, or any histology other than FL grade 1-3a or MZL.
History of or current relevant CNS pathology, as described in the protocol.
A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer treated with hormone therapy or local radiotherapy (ie, pellets), cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated.
Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.
Allergy/hypersensitivity to study drugs or excipients.
Active infection as defined in the protocol.

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

470

Study ID:

NCT06149286

Recruitment Status:

Recruiting

Sponsor:

Regeneron Pharmaceuticals

Check Your Eligibility

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

What is your age and gender ?

Submit

There are 65 Locations for this study

See Locations Near You

IU Simon Cancer Center
Indianapolis Indiana, 46202, United States
Stony Brook University Medical Center- Cancer Center
Stony Brook New York, 11794, United States
Clinical Research Alliance
Westbury New York, 11590, United States
Prohealth Care, Inc
Waukesha Wisconsin, 84052, United States
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
Epworth Freemasons Hospital
East Melbourne Victoria, 3121, Australia
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Gent Oost-Vlaanderen, 9000, Belgium
Institut Jules Bordet, Hopital Universitaire de Bruxelles (HUB) Site Bordet
Brussels , 1000, Belgium
CHU UCL Namur
Yvoir , 5530, Belgium
Fakultni Nemocnice Hradec Kralove
Hradec Kralove 5 , 50005, Czechia
Hopital Saint Louis
Paris Cedex 10, 75010, France
CHU Tours - Hopital Bretonneau
Tours Centre-Val De Loire, 37044, France
Policlinique Bordeaux Nord
Bordeaux Cedex Gironde, 33077, France
CHU Bordeaux - GH Sud Haut-Leveque Francois Magendie Center
Pessac Gironde, 33600, France
Avicenne Hospital
Bobigny Ile De France, 93000, France
Hopital Saint Vincent de Paul
Lille cedex Nord, 5900, France
Centre Henri Becquerel
Rouen Normandie, 76038, France
Centre Hospitalier Metropole Savoie
Chambery Savoie, 73000, France
Nantes University Hospital
Nantes , 44093, France
Hopital Saint Antoine
Paris , 75571, France
Chu Pontchaillou
Rennes , 35033, France
Hopital Victor Dupouy Argenteuil
Argenteuil Île De France, 95100, France
Irccs Irst Meldola
Meldola (fc) Forli-Cesena, 47014, Italy
IRCSS San Gerardo dei Tintori
Monza Monza E Brianza, 20900, Italy
FPO-IRCCS Candiolo Cancer Institute
Candiolo Torino, 10060, Italy
Ospedale Policlinico San Martino IRCCS
Genova , 16132, Italy
Farmacia Centralizzata
Napoli , 80128, Italy
AOU Maggiore della Carita
Novara , 28100, Italy
Ospedale Santa Maria Delle Croci
Ravenna , 48121, Italy
Gachon University Gil Medical Center
Seongnam-si Gyeonggi-do, 13520, Korea, Republic of
Inje University Busan Paik Hospital
Busan , 47392, Korea, Republic of
Pusan National University Hospital (PNUH)
Busan , 49241, Korea, Republic of
Yeungnam University Medical Center
Daegu , 42415, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
The Catholic University of Korea, Seoul St. Marys Hospital
Seoul , 137-7, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul , 137-7, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital
Suwon , 16247, Korea, Republic of
Ulsan University Hospital
Ulsan , 44033, Korea, Republic of
Hospital Sultanah Aminah
Johor Bahru Johor, 80100, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu Sabah, 88586, Malaysia
Hospital Ampang
Ampang Selangor, 68000, Malaysia
Pratia McM Krakow
Krakow Malopolska, 30-51, Poland
Centrum Medyczne Pratia Poznan
Poznan Wielkopolska, 60185, Poland
Pratia Onkologia Katowice
Katowice , 40-51, Poland
Hospital Son Espases
Palma Balearic Islands, 07120, Spain
Hosptial Universitario Marques de Valdecilla
Santander Cantabria, 39008, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón Madrid, 28223, Spain
University Hospital Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario Virgen de las Nieves
Granada , 18014, Spain
Hospital Universiterio Ramon Y Cajal
Madrid , 28034, Spain
Hospital HM Sanchinarro
Madrid , 28050, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Virgen del Rocio
Seville , 41013, Spain
Hospital Universitario Doctor Peset
Valencia , 46017, Spain
National Taiwan University Hospital
Taipei City , 10002, Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City , 333, Taiwan
Chulalongkorn University
Bangkok Krung Thep Maha Nakhon [Bangko], 10330, Thailand
Siriraj Institute of Clinical Research (SICRES)
Bangkok , 10700, Thailand
Chiang Mai University
Chiang Mai , 50200, Thailand
Ankara Research Hospital
Yenimahalle Ankara, 06200, Turkey
Namik Kemal Universitesi
Tekirdag Suleymanpasa, 59100, Turkey
Gazi University
Ankara , 06100, Turkey
Dokuz Eylul University
Izmir , 35340, Turkey
Sakarya University Training and Research Hospital
Sakarya , 54290, Turkey
University Hospitals Plymouth NHS Trust
Plymouth Devon, PL6 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

470

Study ID:

NCT06149286

Recruitment Status:

Recruiting

Sponsor:


Regeneron Pharmaceuticals

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

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

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider