A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)
Фаза 3 – широко изпитване преди одобрение
Заболявания:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Спонсор: BeOne Medicines
Налично на:
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Обобщение
The goal of this study is to compare how well sonrotoclax plus obinutuzumab works versus venetoclax plus rituximab in treating adults with relapsed and/or refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The study will also compare how well sonrotoclax plus rituximab works versus venetoclax plus rituxumab in treating adults with R/R CLL/SLL. The safety of these treatments will also be assessed.
Описание
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Кой може да участва
Inclusion Criteria:
* Confirmed diagnosis of CLL/SLL that meets the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria
* Received one or more prior therapies for CLL/SLL. For each line of therapy, participants must have received at least 2 cycles of the therapy
* Participants with prior BCL2i exposure are eligible if remission duration was ≥3 years with ≥2 years from last BCL2i intake
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
* Adequate organ function
Exclusion Criteria:
* Known active prolymphocytic leukemia or currently suspected Richter's transformation
* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
* Known central nervous system involvement by CLL/SLL
* Severe or debilitating pulmonary disease
* Clinically significant cardiovascular disease
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Интервенции
Sonrotoclax
DRUG
Obinutuzumab
DRUG
Rituximab
DRUG
Venetoclax
DRUG
Места на провеждане
167
Argentina (1)
FUNDALEU
Caba
Австралия (13)
Sunshine Coast Hospital and Health Service
Birtinya , Queensland
Blacktown Cancer and Haematology Centre
Blacktown , New South Wales
Monash Health
Clayton , Victoria
Rockingham Hospital
Cooloongup , Western Australia
St Vincents Hospital Melbourne
Fitzroy , Victoria
St George Hospital
Kogarah , New South Wales
Northern Nsw Health District
Lismore , New South Wales
The Alfred Hospital
Melbourne , Victoria
Peter Maccallum Cancer Centre
Melbourne , Victoria
Macquarie University
North Ryde , New South Wales
Genesiscare North Shore
St Leonards , New South Wales
Perth Blood Institute
West Perth , Western Australia
Princess Alexandra Hospital
Woolloongabba , Queensland
Австрия (3)
Medizinische Universitatsklinik Innsbruck
Innsbruck
Medical University Vienna Oncology
Vienna
Hanusch Krankenhaus
Vienna
Белгия (3)
Cliniques Universitaires Saint Luc
Brussels
Uz Antwerpen
Edegem
University Hospitals Leuven
Leuven
Бразилия (14)
CETUS
Belo Horizonte
ACTIVE_NOT_RECRUITING
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas
ACTIVE_NOT_RECRUITING
Hospital Erasto Gaertner
Curitiba
ACTIVE_NOT_RECRUITING
Complexo Hospitalar de Niteroi
Niterói
ACTIVE_NOT_RECRUITING
Irmandade Da Santa Casa de Misericordia Hospital Porto Alegre
Porto Alegre
ACTIVE_NOT_RECRUITING
Hospital Sao Lucas
Rio de Janeiro
ACTIVE_NOT_RECRUITING
Instituto Dor de Pesquisa E Ensino Rio de Janeiro
Rio de Janeiro
ACTIVE_NOT_RECRUITING
Hospital Santa Izabel
Salvador
ACTIVE_NOT_RECRUITING
Hospital Samaritano Sao Paulo
São Paulo
ACTIVE_NOT_RECRUITING
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo
ACTIVE_NOT_RECRUITING
Hospital Nove de Julho Dasa
São Paulo
ACTIVE_NOT_RECRUITING
Instituto Brasileiro de Controle Do Cancer
São Paulo
ACTIVE_NOT_RECRUITING
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo
ACTIVE_NOT_RECRUITING
Hospital Santa Rita de Cassia Afecc
Vitória
ACTIVE_NOT_RECRUITING
Канада (5)
Arthur Je Child Comprehensive Cancer Centre
Calgary , Alberta
Ciusss Nim Hscm
Montreal , Quebec
The Ottawa Hospital
Ottawa , Ontario
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec
Newfoundland and Labrador Health Services
St. John's , Newfoundland and Labrador
Китай (24)
China Japan Friendship Hospital
Beijing , Beijing Municipality
Xiangya Hospital of Central South University
Changsha , Hunan
West China Hospital, Sichuan University
Chengdu , Sichuan
Fujian Provincial Hospital
Fuzhou , Fujian
Fujian Medical University Union Hospitalqishan Branch
Fuzhou , Fujian
Guangzhou First Peoples Hospital
Guangzhou , Guangdong
Nanfang Hospital, Southern Medical University
Guangzhou , Guangdong
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot , Inner Mongolia
Shandong Provincial Hospital
Jinan , Shandong
Jining No1 Peoples Hospital West Branch
Jining , Shandong
Jiangxi Cancer Hospital
Nanchang , Jiangxi
Zhongda Hospital Southeast University
Nanjing , Jiangsu
Guangxi Medical University Cancer Hospital Wuxiang Branch
Nanning , Guangxi
The Affiliated Peoples Hospital of Ningbo University
Ningbo , Zhejiang
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao , Shandong
Affiliated Zhongshan Hospital of Fudan University
Shanghai , Shanghai Municipality
Liaoning Cancer Hospital and Institute
Shenyang , Liaoning
The Second Hospital of Hebei Medical University
Shijiazhuang , Hebei
Suzhou Municipal Hospitalbaita Branch
Suzhou , Jiangsu
Taizhou Hospital of Zhejiang Province (East)
Taizhou , Zhejiang
Affiliated Hospital of Jiangnan University South Campus
Wuxi , Jiangsu
Shaanxi Provincial Peoples Hospital
Xi'an , Shaanxi
The First Affiliated Hospital of Xiamen University
Xiamen , Fujian
Northern Jiangsu Peoples Hospital
Yangzhou , Jiangsu
Чехия (4)
Fakultni Nemocnice Brno
Brno
Fakultni Nemocnice Hradec Kralove
Hradec Králové
Vseobecna Fakultni Nemocnice V Praze
Prague
Ustav Hematologie A Krevni Transfuze (Uhkt)
Prague
Дания (4)
University Hospital of Aalborg
Aalborg
Rigshospitalet
Copenhagen
Odense University Hospital
Odense C
Zealand University Hospital, Roskilde
Roskilde
Франция (9)
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
Clermontferrand
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes
Hopital de La Pitie Salpetriere
Paris
Chu Hopital Lyon Sud
PierreBenite
Hopital Robert Debre
Reims
Chu Rennes
Rennes Cedes
Centre Henri Becquerel
Rouen
Iuct Oncopole
Toulouse
Chu Nancy Hopital Brabois
VandoeuvrelesNancy
Германия (11)
Osp Kurfuerstendamm
Berlin
Uniklinik Koeln (Aoer)
Cologne
Gokos Gmbh
Dresden
Universitatsklinikum Jena Klinik Fur Innere Medizin Ii
Jena
Universitatsklinikum Schleswig Holstein, Campus Kiel
Kiel
Klinikum Der Universitat Munchen Medizinische Klinik Und Poliklinik Iii
München
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
Mutlangen
Dietrich Bonhoeffer Klinikum Neubrandenburg
Neubrandenburg
Medizinische Universitaetsklinik
Tübingen
Universitaetsklinikum Ulm
Ulm
Haematologisch Onkologische Schwerpunktpraxis
Würzburg
Ireland (4)
St Jamess Hospital
Dublin
Mater Misericordiae University Hospital
Dublin
University Hospital Galway
Galway
University Hospital Limerick
Limerick
Италия (7)
Azienda Ospedaliera Policlinico Di Bari
Bari
Ao Brotzu Ospedale Oncologico Armando Businco
Cagliari
Po Grodolico, Aou Policlinico Vittorio Emanuele Di Catania
Catania
Azienda Ospedaliero Universitaria Di Ferrara
Ferrara
Ospedale San Raffaele
Milan
Universita Degli Studi Di Modena Azienda Ospedaliere Policlinco
Modena
Asl Salerno Andrea Tortora
Pagani
Нидерландия (4)
Flevoziekenhuis
Almere Stad
Rijnstate
Arnhem
Albert Schweitzer Ziekenhuis
Dordrecht
Tergooi Mc
Hilversum
New Zealand (2)
North Shore Hospital
Auckland
Auckland City Hospital
Auckland
Полша (1)
Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
Torun
Южна Корея (7)
Samsung Medical Center
GangnamGu , Seoul Teugbyeolsi
National Cancer Center (Korea)
IlsandongGu GoyangSi , Gyeonggi-do
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu , Seoul Teugbyeolsi
Severance Hospital Yonsei University Health System
SeodaemunGu , Seoul Teugbyeolsi
Pusan National University Hospital
Seogu , Busan Gwang'yeogsi
Seoul National University Bundang Hospital
Seongnam-si , Gyeonggi-do
Seoul National University Hospital
Seoul , Seoul Teugbyeolsi
Испания (9)
Vall D Hebron Institute of Oncology Vhio
Barcelona
Hospital Clinic de Barcelona
Barcelona
Ico Lhospitalet Hospital Duran I Reynals
Lhospitalet de Llobregat
Hospital de La Princesa
Madrid
Hospital Universitario Infanta Leonor
Madrid
Costa Del Sol (Marbella, Malaga)
Marbella
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario Marques de Valdecilla
Santander
Hospital Virgen de Valme (Sevilla)
Seville
Швеция (4)
Sahlgrenska University Hospital Hematology
Gothenburg
Skanes Universitetssjukhus I Lund
Lund
Karolinska Universitetssjukhuset Solna
Stockholm
Uppsala Akademiska Sjukhus
Uppsala
Великобритания (5)
University Hospitals Dorset Royal Bournemouth Hospital
Bournemouth
Kings College Hospital
London
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral
Freeman Hospital
Newcastle upon Tyne
Royal Cornwall Hospitalsnhs Trust
Truro
САЩ (33)
Rocky Mountain Cancer Centers (Williams) Usor
Aurora , Colorado
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore , Maryland
Mary Bird Perkins Cancer Center
Baton Rouge , Louisiana
Dana Farber Cancer Institute
Boston , Massachusetts
University of North Carolina At Chapel Hill
Chapel Hill , North Carolina
Levine Cancer Center
Charlotte , North Carolina
Tennessee Oncology Greco Hainsworth Centers For Research Chattanooga
Chattanooga , Tennessee
Northwestern University
Chicago , Illinois
Oncology Hematology Care Clinical Trials, Llc
Cincinnati , Ohio
Texas Oncology Baylorcharles A Sammons Cancer Center
Dallas , Texas
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene , Oregon
The Cancer and Hematology Centers
Grand Rapids , Michigan
Penn State Milton S Hershey Medical Center
Hershey , Pennsylvania
Uci Health Laguna Hills
Laguna Hills , California
University of Louisville, Brown Cancer Center
Louisville , Kentucky
Tennessee Oncology
Nashville , Tennessee
Yale University, Yale Cancer Center
New Haven , Connecticut
Memorial Sloan Kettering Cancer Center Mskcc
New York , New York
Illinois Cancer Specialists (Niles) Usor
Niles , Illinois
Eastern Connecticut Hematology and Oncology
Norwich , Connecticut
Chao Family Comprehensive Cancer Center
Orange , California
Stanford Cancer Institute
Palo Alto , California
Thomas Jefferson University
Philadelphia , Pennsylvania
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh , Pennsylvania
Mayo Clinic Rochester
Rochester , Minnesota
Texas Oncology San Antonio Medical Center Usor
San Antonio , Texas
Scripps Prebys Cancer Center
San Diego , California
Sidney Kimmel Comprehensive Cancer Center Washington Twp
Sewell , New Jersey
Texas Oncology Tyler
Tyler , Texas
Northwest Cancer Specialist, Pc(Us Oncology Research)
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