Trial Title:
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
NCT ID:
NCT06097364
Condition:
Follicular Lymphoma (FL)
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
Conditions: Keywords:
Non-Hodgkin lymphomas (NHL)
Relapsed or Refractory (R/R) FL
B-cells NHL (B-NHL)
Untreated FL
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 + Chemotherapy
Arm group label:
Odronextamab + Chemotherapy + Maintenance
Arm group label:
Odronextamab + Chemotherapy + No maintenance
Arm group label:
Rituximab + Chemotherapy
Other name:
REGN1979
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Administered by IV infusion, or subcutaneous (SC)
Arm group label:
Rituximab + Chemotherapy
Other name:
Rituxan
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Administered by IV infusion
Arm group label:
Odronextamab + Chemotherapy
Arm group label:
Rituximab + Chemotherapy
Other name:
Cytoxan
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Administered by IV infusion
Arm group label:
Odronextamab + Chemotherapy
Arm group label:
Rituximab + Chemotherapy
Other name:
Adriamycin
Intervention type:
Drug
Intervention name:
Vincristine
Description:
Administered by IV infusion
Arm group label:
Odronextamab + Chemotherapy + Maintenance
Arm group label:
Odronextamab + Chemotherapy + No maintenance
Arm group label:
Rituximab + Chemotherapy
Other name:
Oncovin
Intervention type:
Drug
Intervention name:
Prednisone/Prenisolone
Description:
Administered orally (PO)
Arm group label:
Odronextamab + Chemotherapy
Arm group label:
Rituximab + Chemotherapy
Other name:
Deltasone/Omnipred
Summary:
This study is researching an experimental drug called odronextamab, referred to as study
drug. The study is focused on participants with previously untreated follicular lymphoma.
Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with
follicular lymphoma that has come back after treatment (called "relapsed") or did not
respond to treatment (called "refractory") are eligible to take part only in Part 1A of
the study.
This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2
(randomized - controlled).
The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study
drug in combination with chemotherapy is and to determine the dose and schedule of the
study drug to be combined with chemotherapy to be used in Part 2 of the study.
The aim of Part 2 of the study is to assess how effective the combination of the study
drug with chemotherapy is in comparison with the combination of rituximab and
chemotherapy (the current standard-of-care for NHL). 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
- 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. Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a,
stage II bulky or stage III / IV
1. For Part 1A: previously untreated participants who have Follicular Lymphoma
International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
2. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
3. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
2. Have measurable disease on cross sectional imaging documented by diagnostic computed
tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the
protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
4. Adequate bone marrow and hepatic function.
Key Exclusion Criteria:
1. Participants with central nervous system lymphoma or leptomeningeal lymphoma
2. Participants with histological evidence of transformation to a high-grade or diffuse
large B-cell lymphoma
3. Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma),
grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic
lymphoma
4. Recent major surgery and history or organ transplantation
5. A malignancy other than NHL unless the participant is adequately and definitively
treated and 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.
Note: Other protocol-defined Inclusion/Exclusion criteria apply
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Investigative Clinical Research of Indiana
Address:
City:
Noblesville
Zip:
46062
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Ruemu Birhiray
Email:
Principal Investigator
Facility:
Name:
University of Kentucky
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Chaitanya Iragavarapu
Email:
Principal Investigator
Facility:
Name:
Henry Ford Hospital
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Jawad Sheqwara
Email:
Principal Investigator
Facility:
Name:
Cancer and Hematology Centers of Western Michigan
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Colin Hardin
Email:
Principal Investigator
Facility:
Name:
Clinical Research Alliance, Inc.
Address:
City:
Westbury
Zip:
11590
Country:
United States
Status:
Recruiting
Investigator:
Last name:
James D'Olimpio
Email:
Principal Investigator
Facility:
Name:
Center for Oncology and Blood Disorders
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Luis Camacho
Email:
Principal Investigator
Facility:
Name:
Community Cancer Trials of Utah
Address:
City:
Ogden
Zip:
84405
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Carl Gray
Email:
Principal Investigator
Facility:
Name:
ProHealth Care Inc
Address:
City:
Waukesha
Zip:
53188
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Timothy Wassenaar
Email:
Principal Investigator
Facility:
Name:
Liverpool Hopsital
Address:
City:
Liverpool
Zip:
2170
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Vu Minh Hua
Email:
Principal Investigator
Facility:
Name:
Calvary Mater Newcastle
Address:
City:
Waratah
Zip:
2298
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Aung Thant
Email:
Principal Investigator
Facility:
Name:
Pindara Private Hospital
Address:
City:
Benowa
Zip:
4217
Country:
Australia
Status:
Recruiting
Investigator:
Last name:
Hanlon Sia
Email:
Principal Investigator
Facility:
Name:
University Hospital Ghent
Address:
City:
Ghent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Ciel De Vriendt
Email:
Principal Investigator
Facility:
Name:
Vzw - Vitaz
Address:
City:
Sint-Niklaas
Zip:
9100
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Vanessa Van Hende
Email:
Principal Investigator
Facility:
Name:
CHR Verviers
Address:
City:
Verviers
Zip:
4000
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Selim Sid
Email:
Principal Investigator
Facility:
Name:
AZ Groeninge
Address:
City:
Kortrijk
Zip:
8500
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Koenraad Van Eygen
Email:
Principal Investigator
Facility:
Name:
Hopital Universitaire de Bruxelles - Site Bordet
Address:
City:
Brussels
Zip:
1000
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Fulvio Massaro
Email:
Principal Investigator
Facility:
Name:
Pontificia Universidad Catolica de Chile
Address:
City:
Santiago
Zip:
7550000
Country:
Chile
Status:
Recruiting
Investigator:
Last name:
James Campell
Email:
Principal Investigator
Facility:
Name:
Immunocel
Address:
City:
Santiago
Zip:
7580206
Country:
Chile
Status:
Recruiting
Investigator:
Last name:
Alejandro Berkovitz Caceres
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad de los Andes
Address:
City:
Santiago
Zip:
7620157
Country:
Chile
Status:
Recruiting
Investigator:
Last name:
Cristian Carvallo
Email:
Principal Investigator
Facility:
Name:
Hadassah Medical Center
Address:
City:
Jerusalem
Zip:
91220
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Neta Goldschmidt
Email:
Principal Investigator
Facility:
Name:
Rabin Medical Center
Address:
City:
Petah Tikva
Zip:
49100
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Ronit Gurion
Email:
Principal Investigator
Facility:
Name:
Tel Aviv Sourasky Medical Center
Address:
City:
Tel Aviv
Zip:
64239
Country:
Israel
Status:
Recruiting
Investigator:
Last name:
Irit Avivi
Email:
Principal Investigator
Facility:
Name:
Universita degli Studi di Napoli Federico II
Address:
City:
Naples
Zip:
80128
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Fabrizio Pane
Email:
Principal Investigator
Facility:
Name:
Azienda Unita Sanitaria Locale
Address:
City:
Ravenna
Zip:
48121
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Monica Tani
Email:
Principal Investigator
Facility:
Name:
Azienda Unità Sanitaria Locale IRCCS Arcispedale Santa Maria Nuova
Address:
City:
Reggio Emilia
Zip:
42123
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Stefano Luminari
Email:
Principal Investigator
Facility:
Name:
Instituto Scientifico Romagnolo
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Gerardo Musuraca
Email:
Principal Investigator
Facility:
Name:
Azienda Ospedaliera di Perugia
Address:
City:
Perugia
Zip:
06132
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Flavio Falcinelli
Email:
Principal Investigator
Facility:
Name:
IEO Istituo Europeo di Oncologia
Address:
City:
Milano
Zip:
20141
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Enrico Derenzini
Email:
Principal Investigator
Facility:
Name:
Azienda Sanitaria Universitaria del Friuli Centrale
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Jacopo Oliveri
Email:
Principal Investigator
Facility:
Name:
Szpital Uniwersytecki Nr2 Bydgoszcz
Address:
City:
Bydgoszcz
Zip:
85-168
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Jaroslaw Czyz
Email:
Principal Investigator
Facility:
Name:
Szpital Szpecjalistyczny w Walbrzychu
Address:
City:
Walbrzych
Zip:
58-300
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Aleksandra Butrym
Email:
Principal Investigator
Facility:
Name:
Malopolskie Centrum Medyczne SC
Address:
City:
Krakow
Zip:
30-510
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Wojciech Jurczak
Email:
Principal Investigator
Facility:
Name:
Uniwersyteckie Centrum Kliniczne
Address:
City:
Gdansk
Zip:
80-214
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Michal Taszner
Email:
Principal Investigator
Facility:
Name:
Pratia Onkologia Katowice
Address:
City:
Katowice
Zip:
40-519
Country:
Poland
Status:
Recruiting
Investigator:
Last name:
Sebastian Grosicki
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Central de Asturias
Address:
City:
Oviedo
Zip:
33011
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Angel Ramirez Payer
Email:
Principal Investigator
Facility:
Name:
Consorci Corporacio Sanitaria Parc Tauli
Address:
City:
Sabadell
Zip:
08290
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Juan Alfonso Soler Campos
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Puerta de Hierro Majadahonda
Address:
City:
Majadahonda
Zip:
28222
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Mariano Provencio Pulla
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad de Navarra - Sede Pamplona
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Carlos Grande
Email:
Principal Investigator
Facility:
Name:
Clinica Universidad de Navarra - Sede Madrid
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Carlos Grande Garcia
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Infanta Leonor
Address:
City:
Madrid
Zip:
28031
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Jose-Angel Hernandez-Rivas
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Francisco Javier Lopez Jimenez
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Raul Cordoba
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario 12 de Octubre
Address:
City:
Madrid
Zip:
28041
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Ana Jimenez Ubieto
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Quironsalud Madrid
Address:
City:
Madrid
Zip:
28223
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Maria Aranzazu Alonso Alonso
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Alejandro Martin Garcia-Sancho
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Fatima de la Cruz Vicente
Email:
Principal Investigator
Facility:
Name:
Hospital Universitari Mutua Terrassa
Address:
City:
Terrassa
Zip:
08221
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Ana Muntanola Prat
Email:
Principal Investigator
Facility:
Name:
Hospital Universitario de Toledo
Address:
City:
Toledo
Zip:
45007
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Luis Felipe Casado Montero
Email:
Principal Investigator
Facility:
Name:
Instituto Valenciano de Oncologia
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Recruiting
Investigator:
Last name:
Marcos Melian Sosa
Email:
Principal Investigator
Facility:
Name:
Kaohsiung Chang Gung Memorial Hospital
Address:
City:
Kaohsiung City
Zip:
833401
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Ming-Chung Wang
Email:
Principal Investigator
Facility:
Name:
Taipei Medical University Shuang Ho Hospital
Address:
City:
New Taipei City
Zip:
23561
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Tsu Yi Chao
Email:
Principal Investigator
Facility:
Name:
Kaohsiung Medical University Hospital
Address:
City:
Kaohsiung
Zip:
80756
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Shih-Feng Cho
Email:
Principal Investigator
Facility:
Name:
Tri-Service General Hospital
Address:
City:
Taipei City
Zip:
11490
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Yeu Chin Chen
Email:
Principal Investigator
Facility:
Name:
Taipei Municipal Wan Fang Hospital
Address:
City:
Taipei
Zip:
11696
Country:
Taiwan
Status:
Recruiting
Investigator:
Last name:
Tzeon-Jye Chiou
Email:
Principal Investigator
Facility:
Name:
Chulalongkorn University
Address:
City:
Bangkok
Zip:
10330
Country:
Thailand
Status:
Recruiting
Investigator:
Last name:
Kitsada Wudhikarn
Email:
Principal Investigator
Facility:
Name:
Srinagrind Hospital
Address:
City:
Khon Kaen
Zip:
40000
Country:
Thailand
Status:
Recruiting
Investigator:
Last name:
Chinadol Wanitpongpun
Email:
Principal Investigator
Facility:
Name:
Sakayra University Training and Research Hospital
Address:
City:
Adapazari
Zip:
54290
Country:
Turkey
Status:
Recruiting
Investigator:
Last name:
Tuba Hacibekiroglu
Email:
Principal Investigator
Facility:
Name:
Gazi University
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Recruiting
Investigator:
Last name:
Munci Yagci
Email:
Principal Investigator
Facility:
Name:
Liv Hospital
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Recruiting
Investigator:
Last name:
Saadettin Kilickap
Email:
Principal Investigator
Facility:
Name:
Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Address:
City:
Ankara
Zip:
06200
Country:
Turkey
Status:
Recruiting
Investigator:
Last name:
Fevzi Altuntas
Email:
Principal Investigator
Facility:
Name:
Istanbul University
Address:
City:
Istanbul
Zip:
34093
Country:
Turkey
Status:
Recruiting
Investigator:
Last name:
Mustafa Yenerel
Email:
Principal Investigator
Facility:
Name:
VKV American Hospital
Address:
City:
Istanbul
Zip:
34365
Country:
Turkey
Status:
Recruiting
Investigator:
Last name:
Ahmet Ferhanoglu
Email:
Principal Investigator
Facility:
Name:
Erciyes University
Address:
City:
Kayseri
Zip:
38030
Country:
Turkey
Status:
Recruiting
Investigator:
Last name:
Ali Unal
Email:
Principal Investigator
Facility:
Name:
Ondokuz Mayis University
Address:
City:
Samsun
Zip:
55200
Country:
Turkey
Status:
Recruiting
Investigator:
Last name:
Duzgun Ozatli
Email:
Principal Investigator
Facility:
Name:
Tekirdag Namik Kemal University Hospital
Address:
City:
Tekirdag
Zip:
59100
Country:
Turkey
Status:
Recruiting
Investigator:
Last name:
Burhan Turgut
Email:
Principal Investigator
Facility:
Name:
Aberdeen Royal Infirmary
Address:
City:
Aberdeen
Zip:
AB25 2ZN
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Gavin Preston
Email:
Principal Investigator
Facility:
Name:
Royal Cornwall Hospital NHS Trust
Address:
City:
Truro
Zip:
TR1 3LJ
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
David Tucker
Email:
Principal Investigator
Facility:
Name:
Queen Elizabeth Hospital
Address:
City:
Birmingham
Zip:
B15 2SY
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Shankara Paneesha
Email:
Principal Investigator
Start date:
November 14, 2023
Completion date:
July 29, 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/NCT06097364
