Исследование, чтобы выяснить, насколько хорошо работает одронекстамаб в сочетании с химиотерапией и насколько он безопасен по сравнению с ритуксимабом и химиотерапией у взрослых участников с ранее не леченной фолликулярной лимфомой (OLYMPIA-2)
Открытое рандомизированное исследование фазы 3 для сравнения эффективности и безопасности одронекстамаба (REGN1979), биспецифического анти-CD20x анти-CD3-антитела в сочетании с химиотерапией по сравнению с ритуксимабом в сочетании с химиотерапией у ранее не получавших лечения участников с фолликулярной лимфомой (OLYMPIA- 2)
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
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
-
-
New South Wales
-
Liverpool, New South Wales, Австралия, 2170
- Liverpool Hospital
-
Waratah, New South Wales, Австралия, 2298
- Calvary Mater Newcastle
-
-
Queensland
-
Benowa, Queensland, Австралия, 4217
- Pindara Private Hospital
-
-
-
-
-
Vienna, Австрия, 1090
- Universitatsklinik fur Kinder und Jungendheilkunde
-
Wels, Австрия, 4600
- Klinikum Wels-Grieskirchen
-
-
Lower Austria
-
Sankt Pölten, Lower Austria, Австрия, 3100
- Karl Landsteiner University Hospital St. Poelten
-
-
Styria
-
Graz, Styria, Австрия, 8036
- Medical University of Graz
-
Leoben, Styria, Австрия, 8700
- Landeskrankenhaus Hochsteiermark
-
-
Tyrol
-
Innsbruck, Tyrol, Австрия, 6020
- Innsbruck Medical University
-
-
Upper Austria
-
Linz, Upper Austria, Австрия, 4020
- Kepler University Hospital
-
-
-
-
-
Brussels, Бельгия, 1000
- Institut Jules Bordet
-
Liège, Бельгия, 4000
- Centre Hospitalier Regional de la Citadelle
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, Бельгия, 9000
- Universitair Ziekenhuis (UZ) Gent/ Ghent University Hospital
-
Sint-Niklaas, Oost-Vlaanderen, Бельгия, 9100
- Verenigde Ziekenhuizen van Waas en Durme
-
-
West-Vlaanderen
-
Bruges, West-Vlaanderen, Бельгия, 8000
- Algemeen Ziekenhuis St Jan Brugge Oostende Av
-
Kortrijk, West-Vlaanderen, Бельгия, 8500
- AZ Groeninge
-
-
-
-
-
Rio de Janeiro, Бразилия, 20231050
- Instituto Nacional de Cancer Jose Alencar Gomes da Silva
-
São Paulo, Бразилия, 01323-903
- Hospital Alemao Oswaldo Cruz
-
São Paulo, Бразилия, 08270-070
- Casa de Saude Santa Marcelina
-
São Paulo, Бразилия, 01509-010
- AC Camargo Cancer Center
-
São Paulo, Бразилия, 05403-000
- Clinical Hospital of Medicine School at Sao Paulo University
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, Бразилия, 41253-900
- Hospital Sao Rafael
-
Salvador, Estado de Bahia, Бразилия, 41950-640
- Ensino e Terapia de Inovacao Clinica Amo (Etica)
-
Salvador, Estado de Bahia, Бразилия, 40050-410
- Hospital Santa Izabel - Santa Casa de Misericordia da Bahia
-
-
Federal District
-
Brasília, Federal District, Бразилия, 70200-730
- Hospital Sirio Libanes Brasilia
-
Brasília, Federal District, Бразилия, 70390-140
- Instituto DOr de Pesquisa e Ensino Df Star
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Бразилия, 30380-472
- Instituto Mario Pena de Ensino Pesquisa e Inovacao
-
Uberlândia, Minas Gerais, Бразилия, 38408-008
- Centro Oncologico do Triangulo (COT) - Uberlandia
-
-
Paraná
-
Curitiba, Paraná, Бразилия, 81520-060
- Hospital Erasto Gaertner
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Бразилия, 59062-000
- Liga Norte Riograndense Contra o Cancer
-
-
Rio Grande do Sul
-
Bento Gonçalves, Rio Grande do Sul, Бразилия, 95700-084
- Instituto Tacchini de Pesquisa em Saude
-
Passo Fundo, Rio Grande do Sul, Бразилия, 99010-080
- Instituto do Cancer em Hospital Sao Vicente de Paulo
-
Porto Alegre, Rio Grande do Sul, Бразилия, 90035-903
- Hospital de Clinicas de Porto Alegre
-
-
Santa Catarina
-
Joinville, Santa Catarina, Бразилия, 89201-260
- Centro de Hematologia e Oncologia
-
Lages, Santa Catarina, Бразилия, 88501-001
- Animi Unidade de Tratamento Oncologico Ltda
-
-
São Paulo
-
Barretos, São Paulo, Бразилия, 14784-400
- Fundacao Pio XII Hospital de Amor
-
Jaú, São Paulo, Бразилия, 17210-080
- Amaral Carvalho Hospital
-
Ribeirão Preto, São Paulo, Бразилия, 14048-900
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
-
-
-
-
-
Kiel, Германия, 24116
- Stadtisches Krankenhaus Kiel
-
Neuss, Германия, 41462
- MVZ fuer Haematologie und Onkologie Rhein-Kreis GmbH
-
-
-
-
-
Beersheba, Израиль, 84101
- Soroka University Medical Center
-
Haifa, Израиль, 3109601
- Rambam Health Care Campus
-
Jerusalem, Израиль, 91200
- Hadassah Medical Center
-
Petah Tikva, Израиль, 49100
- Rabin Medical Center
-
Tel Aviv, Израиль, 64239
- The Tel Aviv Sourasky Medical Center
-
Tel Aviv, Израиль, 6971028
- Assuta Medical Centers
-
-
Jerusalem
-
Jerusalem, Jerusalem, Израиль, 9103102
- Shaare Zedek Medical Center
-
-
-
-
-
Lugo, Испания, 27003
- Hospital Universitario Lucus Augusti
-
Madrid, Испания, 28027
- Clinica Universidad de Navarra - Madrid
-
Madrid, Испания, 28034
- Hospital Universitario Ramon y Cajal
-
Madrid, Испания, 28041
- Hospital Universitario 12 de Octubre
-
Madrid, Испания, 28031
- Hospital Universitario Infanta Leonor
-
Madrid, Испания, 28040
- Hospital Universitario Fundacion Jimenez Diaz
-
Ourense, Испания, 32005
- Complexo Hospitalario Universitario de Ourense
-
Pamplona, Испания, 31008
- Clinica Universidad de Navarra- Pamplona
-
Salamanca, Испания, 37007
- Hospital Universitario de Salamanca
-
Seville, Испания, 41009
- Hospital Universitario Virgen Macarena
-
Valencia, Испания, 46009
- Instituto Valenciano de Oncologia
-
Valencia, Испания, 46010
- Hospital Clinico Universitario de Valencia
-
-
Andalusia
-
Seville, Andalusia, Испания, 41013
- Hospital Universitario Virgen del Rocio
-
-
Barcelona
-
Sabadell, Barcelona, Испания, 08208
- Parc Tauli Sabadell Hospital Universitari
-
Terrassa, Barcelona, Испания, 08221
- Hospital Universitari Mutua Terrassa
-
-
Bizkaia
-
Barakaldo, Bizkaia, Испания, 48903
- Cruces University Hospital (Hospital Universitario Cruces)
-
-
Madrid
-
Majadahonda, Madrid, Испания, 28222
- Hospital Universitario Puerta de Hierro - Majadahonda
-
Pozuelo de Alarcón, Madrid, Испания, 28223
- Hospital Universitario Quiron Salud Madrid
-
-
Navarre
-
Pamplona, Navarre, Испания, 31008
- Hospital Universitario de Navarra
-
-
Principality of Asturias
-
Oviedo, Principality of Asturias, Испания, 33011
- Hospital Universitario Central de Asturias
-
-
Valencia
-
Alicante, Valencia, Испания, 03010
- Hospital General Universitario Doctor Balmis Alicante
-
-
-
-
-
Milan, Италия, 20141
- Istituto Europeo di Oncologia
-
Milan, Италия, 20162
- ASST Grande Ospedale Metropolitano Niguarda - Main Address
-
Milan, Италия, 20122
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
-
Modena, Италия, 41124
- A.O.U. di Modena
-
Naples, Италия, 80131
- Federico II University
-
Perugia, Италия, 06132
- Azienda Ospedaliera di Perugia
-
Pisa, Италия, 56126
- University of Pisa, Section of Hematology
-
Potenza, Италия, 85100
- Azienda Ospedaliera Regionale San Carlo
-
Ravenna, Италия, 48121
- UO Ematologia Ravenna
-
Reggio Emilia, Италия, 42123
- Azienda Unita Sanitaria Locale Irccs Arcispedale Santa Maria Nuova
-
Rome, Италия, 00161
- Azienda Osperdaliero-Universitaria Policlinico Umberto 1
-
Udine, Италия, 33100
- Azienda Sanitaria Universitaria del Friuli Centrale
-
-
Forli-Cesena
-
Meldola, Forli-Cesena, Италия, 47014
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
-
-
Piedmont
-
Turin, Piedmont, Италия, 10137
- Azienda Ospedaliera Ordine Mauriziano Torino, Presidio Umberto I of Turin
-
-
Sicily
-
Palermo, Sicily, Италия, 90127
- Azienda Ospedaliera Universitario Policlinico Palermo
-
-
-
-
-
Bydgoszcz, Польша, 85-168
- Szpital Uniwersytecki Nr2 Bydgoszcz
-
Gdansk, Польша, 80-952
- Uniwersyteckie Centrum Kliniczne, Building of the Non-Invasive Medicine Center
-
Katowice, Польша, 40-519
- Pratia Onkologia Katowice
-
Lodz, Польша, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. Mikolaja Kopernika w Lodzi (Copernicus Memorial Hospital)
-
Lublin, Польша, 20-954
- Centrum Innowacyjnych Terapii Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
-
Warsaw, Польша, 02781
- Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Warszawa
-
Wałbrzych, Польша, 58-300
- Szpital Szpecjalistyczny w Walbrzychu
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Польша, 30-510
- Matopolskie Centrum Medyczne S.C.
-
-
Wielkopolska
-
Skorzewo, Wielkopolska, Польша, 60185
- Aidport Sp. z o.o.
-
-
-
-
-
Aberdeen, Соединенное Королевство, AB25 2ZN
- NHS Grampian: Aberdeen Royal Infirmary
-
-
Cornwall
-
Truro, Cornwall, Соединенное Королевство, TR1 3LJ
- Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital
-
-
London
-
Uxbridge, London, Соединенное Королевство, UB8 3NN
- The Hillingdon Hospitals NHS Foundation Trust
-
-
West Midlands
-
Birmingham, West Midlands, Соединенное Королевство, B15 2SY
- University Hospitals Birmingham NHS Foundation Trust
-
-
-
-
Florida
-
Plantation, Florida, Соединенные Штаты, 33322
- Boca Raton Clinical Research (BRCR) Global
-
-
Indiana
-
Noblesville, Indiana, Соединенные Штаты, 46062
- Investigative Clinical Research of Indiana
-
-
Kansas
-
Wichita, Kansas, Соединенные Штаты, 67214
- Cancer Center of Kansas
-
-
Kentucky
-
Lexington, Kentucky, Соединенные Штаты, 40536
- University of Kentucky
-
-
Michigan
-
Detroit, Michigan, Соединенные Штаты, 48202
- Henry Ford Health System
-
Grand Rapids, Michigan, Соединенные Штаты, 49503
- Cancer and Hematology Centers of Western Michigan
-
-
Texas
-
Houston, Texas, Соединенные Штаты, 77030
- Center for Oncology and Blood Disorders
-
-
Utah
-
Ogden, Utah, Соединенные Штаты, 84405
- Community Cancer Trials of Utah
-
-
Wisconsin
-
Waukesha, Wisconsin, Соединенные Штаты, 53188
- Prohealth Care Inc
-
-
-
-
-
Khon Kaen, Таиланд, 40002
- Khon Kaen University
-
-
Krung Thep Maha Nakhon [Bangko]
-
Bangkok, Krung Thep Maha Nakhon [Bangko], Таиланд, 10330
- Chulalongkorn University
-
-
-
-
-
Kaohsiung City, Тайвань, 83301
- Kaohsiung Chang Gung Memorial Hospital
-
Kaohsiung City, Тайвань, 80756
- Kaohsiung Medical University Hospital
-
New Taipei City, Тайвань, 23561
- Taipei Medical University - Shuang Ho Hospital
-
Taipei, Тайвань, 11217
- Taipei Veterans General Hospital
-
Taipei, Тайвань, 11490
- Tri-Service General Hospital
-
Taipei, Тайвань, 11696
- Taipei Medical University Multipal Wan Fang University
-
-
-
-
-
Ankara, Турция (Туркие), 06100
- Liv Hospital Ankara
-
Istanbul, Турция (Туркие), 34365
- VKV American Hopital
-
Istanbul, Турция (Туркие), 34418
- Istanbul University
-
Kayseri, Турция (Туркие), 38039
- Erci̇yes Uni̇versi̇ty
-
Samsun, Турция (Туркие), 55270
- Ondokuz Mayıs University
-
Zonguldak, Турция (Туркие), 67100
- Zonguldak Bulent Ecevit University
-
-
Ankara
-
Mamak, Ankara, Турция (Туркие), 06620
- Ankara University Faculty of Medicine
-
Yenimahalle, Ankara, Турция (Туркие), 06200
- Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
-
-
Central Anatolia
-
Ankara, Central Anatolia, Турция (Туркие), 06100
- Gazi University
-
-
Mersin
-
Mezitli, Mersin, Турция (Туркие), 33200
- VM Medical Park Mersin Hospital
-
-
Serdivan
-
Sakarya, Serdivan, Турция (Туркие), 54050
- Sakarya University
-
-
Suleymanpasa
-
Tekirdağ, Suleymanpasa, Турция (Туркие), 59100
- Tekirdag Namik Kemal University Hospital
-
-
-
-
-
Grenoble, Франция, 38043
- Centre Hospitalier Universitaire de Grenoble
-
Le Puy-en-Velay, Франция, 43012
- Centre Hospitalier Emile Roux
-
Lens, Франция, 62300
- Centre Hospitalier de Lens (Centre Hospitalier Dr Schaffner dLens)
-
Paris, Франция, 75010
- Hopital Saint Louis
-
Pessac, Франция, 33600
- Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Sud - Hôpital Haut Lévêque
-
Saint-Etienne, Франция, 42055
- CHU de Saint-Etienne
-
Saint-Nazaire, Франция, 44600
- Centre Hospitalier de Saint Nazaire
-
-
Alpes Maritimes
-
Cannes, Alpes Maritimes, Франция, 06400
- Cannes Hospital (Centre Hospitalier Cannes Simone Veil)
-
-
Centre-Val de Loire
-
Tours, Centre-Val de Loire, Франция, 37044
- CHRU de Tours
-
-
Gard
-
Nîmes, Gard, Франция, 30029
- Institut de Cancerologie du Gard
-
-
New Aquitaine
-
Mont-de-Marsan, New Aquitaine, Франция, 40024
- Centre Hospitalier de Mont-de-Marsan
-
-
Pays de la Loire Region
-
Nantes, Pays de la Loire Region, Франция, 44093
- Nantes University Hospital
-
-
Pontoise
-
Cergy-Pontoise, Pontoise, Франция, 95300
- The Novo Hospital North West Val Deoise
-
-
Île-de-France Region
-
Argenteuil, Île-de-France Region, Франция, 95100
- Hopital Victor Dupouy Argenteuil
-
-
-
-
North Central Czech Republic
-
Hradec Králové, North Central Czech Republic, Чехия, 50005
- University Hospital Hradec Kralove
-
-
South Moravian
-
Brno, South Moravian, Чехия, 62500
- University Hospital Brno
-
-
-
-
Las Condes
-
Santiago, Las Condes, Чили, 7620157
- Hospital Clinico Universidad de Los Andes
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, Чили, 7560907
- Centro Oncologia de Precision Universidad Mayor
-
Santiago, Santiago Metropolitan, Чили, 7580206
- Inmunocel
-
Santiago, Santiago Metropolitan, Чили, 7550000
- Pontificia Universidad Catolica de Chile
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Key Inclusion Criteria:
-
Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
- For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
- For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
- For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
-
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 0-2
-
Adequate bone marrow and hepatic function.
Key Exclusion Criteria:
- Participants with central nervous system lymphoma or leptomeningeal lymphoma
- Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
- Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
- Recent major surgery and history or organ transplantation
- 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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Odronextamab + Chemotherapy
Part 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL. |
Administered by intravenous (IV) infusion
Другие имена:
Administered by IV infusion
Другие имена:
Administered by IV infusion
Другие имена:
Administered orally (PO)
Другие имена:
|
|
Активный компаратор: Rituximab + Chemotherapy
In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance. |
Administered by intravenous (IV) infusion
Другие имена:
Administered by IV infusion
Другие имена:
Administered by IV infusion
Другие имена:
Administered orally (PO)
Другие имена:
Administered by IV infusion, or subcutaneous (SC)
Другие имена:
Administered by IV infusion
Другие имена:
|
|
Экспериментальный: Odronextamab + Chemotherapy + Maintenance
In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy [CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)], followed by odronextamab monotherapy maintenance. |
Administered by intravenous (IV) infusion
Другие имена:
Administered by IV infusion
Другие имена:
|
|
Экспериментальный: Odronextamab + Chemotherapy + No maintenance
In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance. |
Administered by intravenous (IV) infusion
Другие имена:
Administered by IV infusion
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy
Временное ограничение: Up to 35 days
|
Part 1, DLT period |
Up to 35 days
|
|
Incidence of treatment-emergent adverse events (TEAEs) of odronextamab in combination with chemotherapy
Временное ограничение: Up to 2 years
|
Part 1, Treatment period |
Up to 2 years
|
|
Severity of TEAEs of odronextamab in combination with chemotherapy
Временное ограничение: Up to 2 years
|
Part 1, Treatment period |
Up to 2 years
|
|
Complete Response rate at 30 months (CR30) assessed by independent central review (ICR)
Временное ограничение: Up to 30 months
|
Part 2 |
Up to 30 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Overall Survival (OS)
Временное ограничение: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
CR30 as assessed by local investigator
Временное ограничение: Up to 30 months
|
Part 2 |
Up to 30 months
|
|
Incidence of TEAEs
Временное ограничение: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Severity of TEAEs
Временное ограничение: Up to 2 years
|
Part 2 |
Up to 2 years
|
|
Change in Patient Global Impression of Severity (PGIS)
Временное ограничение: Up to 5 years
|
Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe). |
Up to 5 years
|
|
Change in Patient Global Impression of Change (PGIC)
Временное ограничение: Up to 5 years
|
Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse. |
Up to 5 years
|
|
BOR as assessed by ICR
Временное ограничение: Up to 30 months
|
Part 2 |
Up to 30 months
|
|
Odronextamab concentrations in serum when administered with chemotherapy
Временное ограничение: Up to 30 months
|
Part 1, Maintenance period and Part 2, Induction period |
Up to 30 months
|
|
Odronextamab concentrations in serum when administered as monotherapy
Временное ограничение: Up to 30 months
|
Part 1 and Part 2, Maintenance period |
Up to 30 months
|
|
Incidence of anti-odronextamab antibodies (ADAs)
Временное ограничение: Up to 30 months
|
Part 1 and Part 2 |
Up to 30 months
|
|
Titers of ADAs to odronextamab
Временное ограничение: Up to 30 months
|
Part 1 and Part 2 |
Up to 30 months
|
|
Incidence of neutralizing antibodies (NAb) to odronextamab
Временное ограничение: Up to 30 months
|
Part 1 and Part 2 |
Up to 30 months
|
|
Best overall response (BOR) as assessed by the investigator
Временное ограничение: Up to 30 months
|
Part 1, end of Induction period and end of Maintenance period |
Up to 30 months
|
|
Progression free survival (PFS) as assessed by ICR
Временное ограничение: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Change in patient reported physical functioning scale scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)
Временное ограничение: Up to 5 years
|
Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden. |
Up to 5 years
|
|
PFS as assessed by local investigator
Временное ограничение: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Event-free survival (EFS) as assessed by ICR
Временное ограничение: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
EFS as assessed by local investigator
Временное ограничение: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
BOR as assessed by local investigator
Временное ограничение: Up to 30 months
|
Part 2 |
Up to 30 months
|
|
Duration of response (DOR) assessed by ICR
Временное ограничение: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
DOR as assessed by local investigator
Временное ограничение: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Time to next anti-lymphoma treatment (TTNT)
Временное ограничение: Up to 5 years
|
Part 2 |
Up to 5 years
|
|
Change in patient reported health related quality of life (HRQoL) as measured by EORTC-QLQ-C30
Временное ограничение: Up to 5 years
|
Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden. |
Up to 5 years
|
|
Change in cancer disease as measured by EORTC-QLQ-C30
Временное ограничение: Up to 5 years
|
Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden. |
Up to 5 years
|
|
Change in treatment related symptoms as measured by EORTC-QLQ-C30
Временное ограничение: Up to 5 years
|
Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a GHS/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden. |
Up to 5 years
|
|
Change in patient-reported lymphoma disease as measured by the Lymphoma Subscale of the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS)
Временное ограничение: Up to 5 years
|
Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life. |
Up to 5 years
|
|
Change in treatment-related symptoms as measured by the FACT-LymS
Временное ограничение: Up to 5 years
|
Part 2 The FACT-LymS includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life. |
Up to 5 years
|
|
Change in patient-reported general health status per EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Временное ограничение: Up to 5 years
|
Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: "no problems", "slight problems", "moderate problems", "severe problems" and "extreme problems". The EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state". |
Up to 5 years
|
|
Change in patient-reported treatment side effects burden per Functional Assessment of Cancer Therapy-General Global Population Item 5 (FACT-G GP5)
Временное ограничение: Up to 5 years
|
Part 2 A single item GP5 of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4). |
Up to 5 years
|
|
Change in score of the FACT-G GP5 item in the patient population
Временное ограничение: Up to 5 years
|
Part 2 A single item GP5 of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4). |
Up to 5 years
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Clinical Trial Management, Regeneron Pharmaceuticals
Публикации и полезные ссылки
Полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Патологические процессы
- Новообразования
- Атрибуты болезни
- Заболевания иммунной системы
- Новообразования по гистологическому типу
- Лимфатические заболевания
- Лимфопролиферативные заболевания
- Иммунопролиферативные заболевания
- Лимфома, неходжкинская
- Лимфома
- Патологические состояния, признаки и симптомы
- Гемики и лимфатические заболевания
- Повторение
- Лимфома, фолликулярная
- Аминокислоты, пептиды и белки
- Белки
- Органические химические вещества
- Гетероциклические соединения
- Гетероциклические соединения, 2-кольцо
- Гетероциклические соединения, слитое кольцо
- Углеводороды
- Углеводороды, циклические
- Углеводы
- Алкалоиды
- Полициклические ароматические углеводороды
- Углеводороды, ароматные
- Полициклические соединения
- Гликозиды
- Индолы
- Антитела, моноклональные
- Антитела
- Иммуноглобулины
- Иммунопротеины
- Белки крови
- Сывороточные глобулины
- Глобулины
- Беременные
- Беременные
- Стероиды
- Соединения слитого кольца
- Фосфорамид горчицы
- Азотные соединения горчицы
- Горчичные соединения
- Углеводороды, галогенированные
- Фосфорамиды
- Соединения органофосфора
- Bergyadienetriols
- Беременные
- VINCA ALKALOIDS
- Секологические триптаминовые алкалоиды
- Индольные алкалоиды
- Индолизидины
- Индолизины
- Антрациклины
- Нафтацены
- Аминогликозиды
- Антитела, моноклональные, происходящие из мыши
- Даунорубицин
- Преднизолон
- Ритуксимаб
- Преднизолон
- Циклофосфамид
- Доксорубицин
- Винкристин
- Метилпреднизолон
Другие идентификационные номера исследования
- R1979-ONC-2075
- 2022-502113-28-00 (Другой идентификатор: EUCT Number)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Сроки обмена IPD
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
Критерии совместного доступа к IPD
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
- КСО
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .