Trial Title:
A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma
NCT ID:
NCT06149286
Condition:
Relapsed/Refractory Follicular Lymphoma
Marginal Zone Lymphoma (MZL)
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Rituximab
Lenalidomide
Conditions: Keywords:
Relapsed/Refractory Follicular Lymphoma
Marginal Zone Lymphoma
Non-Hodgkin lymphomas
Indolent lymphomas
Odronextamab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Odronextamab
Description:
Administered by intravenous (IV) infusion
Arm group label:
Odronextamab+Lenalidomide
Other name:
REGN1979
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Administered orally (PO)
Arm group label:
Odronextamab+Lenalidomide
Arm group label:
Rituximab+Lenalidomide
Other name:
REVLIMID
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Administered by IV infusion, or subcutaneously (SC)
Arm group label:
Rituximab+Lenalidomide
Other name:
Rituxan
Summary:
This study is researching an experimental drug called odronextamab (referred to as study
drug), in combination with lenalidomide. The study is focused on participants 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 the study drug and
lenalidomide works compared to the combination of rituximab (called "the comparator
drug") and lenalidomide. The combination of comparator drug and lenalidomide is 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 the 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 quality of life and ability to complete routine
daily activities
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Local histologic confirmation of FL grade 1-3a or MZL (nodal, splenic, or extra
nodal MZL) as assessed by the investigator, as described in the protocol.
2. Must have refractory disease or relapsed after at least 1 prior line (with a
duration of at least 2 cycles) of systemic chemo-immunotherapy or immunotherapy.
Prior systemic therapy should have included at least one anti-Cluster of
Differentiation 20 (CD20) monoclonal antibody and participant should meet indication
for treatment, as described in the protocol.
3. Have measurable disease on cross sectional imaging documented by diagnostic Computed
Tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the
protocol.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Adequate hematologic and organ function, as described in the protocol.
6. All study participants must:
1. Have an understanding that lenalidomide could have a potential teratogenic
risk.
2. Agree to abstain from donating blood while taking study drug therapy and for 28
days after discontinuation of lenalidomide.
3. Agree not to share study medication with another person.
4. Agree to be counseled about pregnancy precautions and risk of fetal exposure
associated with lenalidomide.
Key Exclusion Criteria:
1. Primary Central Nervous System (CNS) lymphoma or known involvement (either current
or prior history of CNS involvement) by non-primary CNS NHL, as described in the
protocol.
2. 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.
3. History of or current relevant CNS pathology, as described in the protocol.
4. 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.
5. 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.
6. Allergy/hypersensitivity to study drugs or excipients. as described in the protocol.
7. Active infection as defined in the protocol.
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
David Geffen School of Medicine at UCLA
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
IU Simon Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Facility:
Name:
Stony Brook University Medical Center- Cancer Center
Address:
City:
Stony Brook
Zip:
11794
Country:
United States
Status:
Recruiting
Facility:
Name:
Clinical Research Alliance
Address:
City:
Westbury
Zip:
11590
Country:
United States
Status:
Recruiting
Facility:
Name:
Prohealth Care, Inc
Address:
City:
Waukesha
Zip:
840524
Country:
United States
Status:
Recruiting
Facility:
Name:
Liverpool Hospital
Address:
City:
Sydney
Zip:
2136
Country:
Australia
Status:
Recruiting
Facility:
Name:
Calvary Mater Newcastle
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Status:
Recruiting
Facility:
Name:
Pindara Private Hospital
Address:
City:
Benowa
Zip:
4217
Country:
Australia
Status:
Recruiting
Facility:
Name:
Epworth Freemasons Hospital
Address:
City:
East Melbourne
Zip:
3121
Country:
Australia
Status:
Recruiting
Facility:
Name:
Kepler Universitatsklinikum GmbH
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Klinikum Wels-Grieskirchen GmbH
Address:
City:
Wels
Zip:
4600
Country:
Austria
Status:
Recruiting
Facility:
Name:
Ordensklinikum Linz GmbH Barmherzige Schwestern
Address:
City:
Linz
Zip:
4010
Country:
Austria
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
AZ Delta
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Institut Jules Bordet, Hopital Universitaire de Bruxelles (HUB) Site Bordet
Address:
City:
Brussels
Zip:
1000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
CHU UCL Namur
Address:
City:
Yvoir
Zip:
5530
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Fakultni Nemocnice Hradec Kralove
Address:
City:
Hradec Kralove 5
Zip:
50005
Country:
Czechia
Status:
Recruiting
Facility:
Name:
University Hospital Kralovske Vinohrady
Address:
City:
Prague
Zip:
10034
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Vseobecna fakultni nemocnice v Praze
Address:
City:
Praha
Zip:
12808
Country:
Czechia
Status:
Recruiting
Facility:
Name:
Hopital Saint Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Tours - Hopital Bretonneau
Address:
City:
Tours
Zip:
37044
Country:
France
Status:
Recruiting
Facility:
Name:
Policlinique Bordeaux Nord
Address:
City:
Bordeaux Cedex
Zip:
33077
Country:
France
Status:
Recruiting
Facility:
Name:
CHU Bordeaux - GH Sud Haut-Leveque Francois Magendie Center
Address:
City:
Pessac
Zip:
33600
Country:
France
Status:
Recruiting
Facility:
Name:
Avicenne Hospital
Address:
City:
Bobigny
Zip:
93000
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Saint Vincent de Paul
Address:
City:
Lille cedex
Zip:
5900
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Zip:
76038
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Metropole Savoie
Address:
City:
Chambery
Zip:
73000
Country:
France
Status:
Recruiting
Facility:
Name:
Centre Hospitalier Universitaire de Montpellier - Hopital Saint-Eloi
Address:
City:
Montpellier
Zip:
34290
Country:
France
Status:
Recruiting
Facility:
Name:
Nantes University Hospital
Address:
City:
Nantes
Zip:
44093
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Saint Antoine
Address:
City:
Paris
Zip:
75571
Country:
France
Status:
Recruiting
Facility:
Name:
Chu Pontchaillou
Address:
City:
Rennes
Zip:
35033
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Victor Dupouy Argenteuil
Address:
City:
Argenteuil
Zip:
95100
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94800
Country:
France
Status:
Recruiting
Facility:
Name:
Staedtisches Krankenhaus Kiel GmbH
Address:
City:
Kiel
Zip:
24116
Country:
Germany
Status:
Recruiting
Facility:
Name:
Assuta Medical center
Address:
City:
Ashdod
Zip:
7747629
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center- Ein Kerem
Address:
City:
Jerusalem
Zip:
91200
Country:
Israel
Status:
Recruiting
Facility:
Name:
The Galilee Medical Center
Address:
City:
Nahariya
Zip:
2210001
Country:
Israel
Status:
Recruiting
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah Tikva
Zip:
49100
Country:
Israel
Status:
Recruiting
Facility:
Name:
Irccs Irst Meldola
Address:
City:
Meldola (fc)
Zip:
47014
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCSS San Gerardo dei Tintori
Address:
City:
Monza
Zip:
20900
Country:
Italy
Status:
Recruiting
Facility:
Name:
Centro Di Riferimento Oncologico (CRO), Aviano, National Cancer Institute
Address:
City:
Aviano
Zip:
33081
Country:
Italy
Status:
Recruiting
Facility:
Name:
FPO-IRCCS Candiolo Cancer Institute
Address:
City:
Candiolo
Zip:
10060
Country:
Italy
Status:
Recruiting
Facility:
Name:
IRCCS AOU di Bologna - Policlinico di S.Orsola
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Recruiting
Facility:
Name:
Azienda Ospedaliera (ASST) Spedali Civili di Brescia
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Policlinico San Martino IRCCS
Address:
City:
Genova
Zip:
16132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Istituto Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Facility:
Name:
A.O.U. di Modena
Address:
City:
Modena
Zip:
41124
Country:
Italy
Status:
Recruiting
Facility:
Name:
Farmacia Centralizzata
Address:
City:
Napoli
Zip:
80128
Country:
Italy
Status:
Recruiting
Facility:
Name:
AOU Maggiore della Carita
Address:
City:
Novara
Zip:
28100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Fondazione IRCCS Policlinico San Matteo
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Santa Maria Della Misericordia
Address:
City:
Perugia
Zip:
06132
Country:
Italy
Status:
Recruiting
Facility:
Name:
Ospedale Santa Maria Delle Croci
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Recruiting
Facility:
Name:
SOC Farmacia -Studi clinici- Presidio Ospedaliero Universitario S. Maria della Misericordia
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Gachon University Gil Medical Center
Address:
City:
Seongnam-si
Zip:
13520
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Asan Medical Center (AMC)
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Inje University Busan Paik Hospital
Address:
City:
Busan
Zip:
47392
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Pusan National University Hospital (PNUH)
Address:
City:
Busan
Zip:
49241
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Yeungnam University Medical Center
Address:
City:
Daegu
Zip:
42415
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Severance Hospital, Yonsei University Health System
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea, Seoul St. Marys Hospital
Address:
City:
Seoul
Zip:
137-701
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University of Korea, Yeouido St. Mary's Hospital
Address:
City:
Seoul
Zip:
137-701
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
3080
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
The Catholic University Of Korea St. Vincent's Hospital
Address:
City:
Suwon
Zip:
16247
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Ulsan University Hospital
Address:
City:
Ulsan
Zip:
44033
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Hospital Sultanah Aminah
Address:
City:
Johor Bahru
Zip:
80100
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
University Malaya Medical Centre
Address:
City:
Kuala Lumpur
Zip:
50603
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Queen Elizabeth
Address:
City:
Kota Kinabalu
Zip:
88586
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Hospital Ampang
Address:
City:
Ampang
Zip:
68000
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Subang Jaya Medical Center
Address:
City:
Subang Jaya
Zip:
47500
Country:
Malaysia
Status:
Recruiting
Facility:
Name:
Specjalistyczny Szpital im A. Sokolowskiego w Walbrzychu
Address:
City:
Walbrzych
Zip:
58-309
Country:
Poland
Status:
Recruiting
Facility:
Name:
Pratia McM Krakow
Address:
City:
Krakow
Zip:
30-510
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersyteckie Centrum Kliniczne
Address:
City:
Gdansk
Zip:
80-952
Country:
Poland
Status:
Recruiting
Facility:
Name:
Centrum Medyczne Pratia Poznan
Address:
City:
Poznan
Zip:
60185
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpital Uniwersytecki Nr2 Bydgoszcz
Address:
City:
Bydgoszcz
Zip:
85-168
Country:
Poland
Status:
Recruiting
Facility:
Name:
Pratia Onkologia Katowice
Address:
City:
Katowice
Zip:
40-519
Country:
Poland
Status:
Recruiting
Facility:
Name:
University Hospital of Santiago de Compostela
Address:
City:
Santiago de Compostela
Zip:
15706
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Central de Asturias
Address:
City:
Oviedo
Zip:
33011
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Son Espases
Address:
City:
Palma
Zip:
07120
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosptial Universitario Marques de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Quironsalud Madrid
Address:
City:
Pozuelo de Alarcón
Zip:
28223
Country:
Spain
Status:
Recruiting
Facility:
Name:
University Hospital Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Zip:
08041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen de las Nieves
Address:
City:
Granada
Zip:
18014
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universiterio Ramon Y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universiterio 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital HM Sanchinarro
Address:
City:
Madrid
Zip:
28050
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Seville
Zip:
41013
Country:
Spain
Status:
Recruiting
Facility:
Name:
Instituto Valenciano de Oncologia
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Doctor Peset
Address:
City:
Valencia
Zip:
46017
Country:
Spain
Status:
Recruiting
Facility:
Name:
Changhua Christian Hospital
Address:
City:
Changhua city
Zip:
500-06
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chiayi Chang Gung Memorial Hospital
Address:
City:
Chiayi City
Zip:
613
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Medical University-Shuang Ho Hospital
Address:
City:
New Taipei City
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Cheng-Kung University Hospital
Address:
City:
Tainan City
Zip:
701
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei City
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Tri-Service General Hospital
Address:
City:
Taipei City
Zip:
114
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Taipei Municipal Wan Fang Hospital
Address:
City:
Taipei
Zip:
116
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Address:
City:
Taoyuan City
Zip:
333
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Chulalongkorn University
Address:
City:
Bangkok
Zip:
10330
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Siriraj Institute of Clinical Research (SICRES)
Address:
City:
Bangkok
Zip:
10700
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Chiang Mai University
Address:
City:
Chiang Mai
Zip:
50200
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Ankara Research Hospital
Address:
City:
Yenimahalle
Zip:
06200
Country:
Turkey
Status:
Recruiting
Facility:
Name:
VM Medical Park Mersin Hospital
Address:
City:
Mezitli
Zip:
33200
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Namik Kemal Universitesi
Address:
City:
Tekirdag
Zip:
59100
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Gazi University
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ege University
Address:
City:
Izmir
Zip:
35100
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Dokuz Eylul University
Address:
City:
Izmir
Zip:
35340
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Sakarya University Training and Research Hospital
Address:
City:
Sakarya
Zip:
54290
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Address:
City:
Samsun
Zip:
55270
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Royal Cornwall Hospital NHS Trust
Address:
City:
Truro
Zip:
TR1 3HD
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
University Hospitals Plymouth NHS Trust
Address:
City:
Plymouth
Zip:
PL6 8DH
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Bournemouth Hospital
Address:
City:
Bournemouth
Zip:
BH7 7DW
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Queens Hospital
Address:
City:
Romford
Zip:
RM7 0AG
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Salisbury District Hospital
Address:
City:
Salisbury
Zip:
SP6 2ND
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Hillingdon Hospital NHS Foundation Trust
Address:
City:
Uxbridge
Zip:
UB8 3NN
Country:
United Kingdom
Status:
Recruiting
Start date:
December 28, 2023
Completion date:
January 23, 2029
Lead sponsor:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Regeneron Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06149286
