Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)
2 other identifiers
interventional
303
30 countries
170
Brief Summary
The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2021
Longer than P75 for phase_3
170 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2021
CompletedFirst Posted
Study publicly available on registry
August 6, 2021
CompletedStudy Start
First participant enrolled
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 12, 2031
May 20, 2026
May 1, 2026
7.9 years
July 30, 2021
May 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)
Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.
Up to approximately 5 years
Phase 3: Event-free Survival (EFS)
Time from randomization (enrollment) until treatment failure, relapse or death from any cause, whichever is earlier. Treatment failure is defined as not achieving a hematological complete CR with MRD response \<10-4 by the end of the initial disease assessment period. Relapse is defined as hematologic relapse, extramedullary relapse, and/or molecular relapse (MRD positivity \>= 10\^-3), whichever occurs earlier, in participants with prior achievement of hematologic CR with MRD response \<10\^-4. Participants without an event will be censored at their last evaluable disease assessment date.
Up to approximately 5 years
Phase 3: Overall Survival (OS)
OS is defined as time from randomization (enrollment) until death due to any cause.
Up to approximately 5 years
Secondary Outcomes (35)
Safety run-in: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period
Baseline to Week 14
Safety run-in: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period
Baseline to Week 14
Safety run-in: Relapse-free Survival (RFS)
Up to approximately 5 years
Safety run-in: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)
Up to approximately 5 years
Safety run-in: Steady State Concentration (Css) of Blinatumomab
Up to approximately 34 weeks
- +30 more secondary outcomes
Study Arms (3)
Safety Run-in: Blinatumomab alternating with low-intensity chemotherapy
EXPERIMENTALThe safety run-in will be performed prior to initiating the phase 3 randomized part of the study. This safety run-in is to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The safety run-in also evaluates a shorter dose step interval from (4 days instead of 7 days) and a 1-week (instead of 2-week) drug free interval between blinatumomab cycles. Blinatumomab will be infused at a lower dose for 4 days and increase to a higher dose on Day 5 of the infusion for the remainder of the infusion.
Phase 3: Blinatumomab alternating with low-intensity chemotherapy
EXPERIMENTALParticipants will receive blinatumomab alternating with low-intensity chemotherapy.
Phase 3: Standard of care (SOC) chemotherapy
ACTIVE COMPARATORParticipants will receive 1 of 2 SOC chemotherapy regimens (GMALL or HyperCVAD) per investigator's choice.
Interventions
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Continuous intravenous (cIV) infusion
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Eligibility Criteria
You may qualify if:
- \- Age ≥ 55 years at the time of informed consent. OR
- Age 40 to \< 55 years of age if at least 1 of the following comorbidities at the time of informed consent:
- history of grades 3 and 4 pancreatitis
- diabetes mellitus with end-organ damage
- severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and aspartate transaminase (AST)/alanine aminotransferase (ALT) \> 10 x upper limit of normal (ULN) (liver cirrhosis must be confirmed by biopsy)
- body mass index (BMI) ≥ 40 combined with relevant comorbidities such as metabolic syndrome
- Any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric based, adult adapted standard chemotherapy regimen but still compatible with the suggested protocol for older participants in both the experimental and the SOC arm. The participant history will be reviewed by the medical monitor during screening to determine enrollment acceptability based on a standard list with types of comorbidities allowed.
- Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, higher ECOG score allowed if due to underlying leukemia
- All participants must have adequate organ function as defined below:
- renal: estimated glomerular filtration rate based on MDRD calculation ≥ 50 mL/min/1.73 m\^2
- liver function: total bilirubin ≤ 2x upper limit of normal (ULN; unless Gilbert's Disease or if liver involvement with leukemia); exception for participants 40 to \< 55 years of age if they have a comorbidity listed above: severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and AST/ALT \> 10 x ULN (liver cirrhosis must be confirmed by biopsy)
- cardiac: left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant, uncontrolled, or active cardiovascular disease (eg, myocardial infarction or stroke within 3 months). Consult with medical monitor as needed.
You may not qualify if:
- Active central nervous system (CNS) leukemia (i.e., CNS 3 leukemia, confirmed by lumbar puncture) not resolved with IT chemotherapy during screening.
- History of other malignancy within the past 3 years, with the following exceptions:
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
- Adequately treated breast ductal carcinoma in situ without evidence of disease
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
- Clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric conditions that preclude the use of high dose of corticosteroids
- Current autoimmune disease or history of autoimmune disease with potential CNS involvement
- Known infection with human immunodeficiency virus (HIV)
- Known infection with chronic or active infection with hepatitis B (eg, hepatitis b surface \[HBs\] antigen reactive or quantifiable hepatitis b virus \[HBV\] viral load) or hepatitis C virus (HCV) (eg, HCV RNA \[qualitative\] is detected).
- Active hepatitis B and C based on the following results:
- positive for hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
- negative HepBsAg and positive for hepatitis B core antibody: negative HBV DNA by PCR result is necessary to enroll.
- positive Hepatitis C virus antibody (HepCAb): negative hepatitis C virus RNA by PCR result is necessary to enroll.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (192)
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California Irvine
Orange, California, 92868-3201, United States
University of California San Francisco
San Francisco, California, 94143, United States
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
Orlando, Florida, 32804, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Saint Francis Hospital, Inc
Greenville, South Carolina, 29607, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, 4029, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Austin Health, Austin Hospital
Heidelberg, Victoria, 3084, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Medizinische Universitaet Graz
Graz, 8036, Austria
Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Ordensklinikum Linz Elisabethinen
Linz, 4020, Austria
Hanusch Krankenhaus
Vienna, 1140, Austria
Institut Jules Bordet
Anderlecht, 1070, Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, 8000, Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, 3500, Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, 4000, Belgium
AZ Delta Campus Rumbeke
Roeselare, 8800, Belgium
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
Yvoir, 5530, Belgium
Igesd Instituto de Gestao Estrategica da Saude do Distrito Federal
Brasília, Federal District, 70335-902, Brazil
Hospital das Clinicas da Universidade Federal de Goias
Goiânia, Goiás, 74605-020, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Fundacao Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Hosp Clin Fac Med Ribeirao Preto Usp
Ribeirão Preto, São Paulo, 14048-900, Brazil
Hospital de Base de Sao Jose do Rio Preto
São Jose Do Rio Preto, São Paulo, 15090-000, Brazil
Hemorio
Rio de Janeiro, 22640-000, Brazil
Instituto Cancer Sao Paulo Icesp
São Paulo, 01246-000, Brazil
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, 40002, Bulgaria
Specialized Hospital for Active Treatment of Hematology Diseases EAD
Sofia, 1797, Bulgaria
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, R3H 0V9, Canada
Queen Elizabeth II, Health Sciences Centre
Halifax, Nova Scotia, B3H 1V8, Canada
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
CEMTL Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
Fundacion Arturo Lopez Perez
Santiago, 7500921, Chile
Inmunocel
Santiago, 7580206, Chile
Clinica Alemana de Santiago
Santiago, 7650729, Chile
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Ustav hematologie a krevni transfuze
Prague, 128 20, Czechia
Aalborg Universitetshospital
Aalborg, 9000, Denmark
Aarhus Universitetshospital
Aarhus N, 8200, Denmark
Rigshospitalet
København Ø, 2100, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
North Estonia Medical Centre
Tallinn, 13 419, Estonia
Tartu University Hospital
Tartu, 51014, Estonia
Helsinki University Hospital
Helsinki, 00029, Finland
Turku University Hospital
Turku, 20521, Finland
Hopital Henri Mondor
Créteil, 94010, France
Centre Hospitalier Universitaire de Dijon - Hopital du Bocage
Dijon, 21000, France
Centre Hospitalier de Versailles - Hopital Andre Mignot
Le Chesnay, 78157, France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, 59000, France
Institut Paoli Calmettes
Marseille, 13009, France
Centre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu
Nantes, 44000, France
Centre Hospitalier Universitaire Archet 2
Nice, 06202, France
Hopital Saint Louis
Paris, 75010, France
Hopital Saint Antoine
Paris, 75012, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, 33604, France
Hopital Lyon Sud
Pierre-Bénite, 69645, France
Centre Hospitalier Universitaire de Rennes
Rennes, 35000, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, 31059, France
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, 54511, France
Universitaetsklinikum Augsburg
Augsburg, 86156, Germany
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12203, Germany
Universitaetsklinikum Dresden
Dresden, 01307, Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225, Germany
Universitaetsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Jena
Jena, 07747, Germany
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, 24105, Germany
Klinikum der LMU Muenchen
München, 81377, Germany
Evangelismos Hospital
Athens, 10676, Greece
Laiko General Hospital of Athens
Athens, 11527, Greece
Attiko General University Hospital
Athens, 12462, Greece
University Hospital of Heraklion
Heraklion, 71500, Greece
University Hospital of Ioannina
Ioannina, 45500, Greece
University Hospital of Larissa
Larissa, 41110, Greece
University Hospital of Patras
Pátrai, 26504, Greece
General Hospital of Thessaloniki Georgios Papanikolaou
Thessaloniki, 57010, Greece
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Princess Margaret Hospital
Kowloon, Hong Kong
Tuen Mun Hospital
New Territories, Hong Kong
Semmelweis Egyetem
Budapest, 1088, Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, 1097, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, 3300, Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
Nyíregyháza, 4400, Hungary
Rambam Medical Center
Haifa, 3109601, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Rabin Medical Center - Beilinson Hospital
Petah Tikva, 4941492, Israel
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, 70124, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
Bergamo, 24127, Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna, 40138, Italy
Ospedale Policlinico San Martino IRCCS
Genova, 16132, Italy
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
Lecce, 73100, Italy
Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo
Mestre (VE), 30174, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Naples, 80131, Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, 06156, Italy
Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito
Pescara, 65124, Italy
Azienda Ospedaliera Policlinico Umberto I
Roma, 00161, Italy
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
Verona, 37134, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Akita University Hospital
Akita, Akita, 010-8543, Japan
Tesshokai Kameda General Hospital
Kamogawa-shi, Chiba, 296-8602, Japan
University of Fukui Hospital
Yoshida-gun, Fukui, 910-1193, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, 830-0011, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295, Japan
Gunma Saiseikai Maebashi Hospital
Maebashi, Gunma, 371-0821, Japan
Sapporo Hokuyu Hospital
Sapporo, Hokkaido, 003-0006, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, 259-1193, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024, Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, 701-1192, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, 545-8586, Japan
Kindai University Hospital
Sakai-shi, Osaka, 590-0197, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, 329-0498, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, 113-8677, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 173-8610, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
Boca Clinical Trials Mexico SC
Mexico City, Mexico City, 01120, Mexico
Centro Oncologico Internacional
Mexico City, Mexico City, 01330, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Hematologica Alta Especialidad
Huixquilucan, 52787, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Unidade Local de Saude de Coimbra, EPE
Coimbra, 3004-561, Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, 1099-023, Portugal
Unidade Local de Saude de Sao Jose, EPE - Hospital de Santo Antonio dos Capuchos
Lisbon, 1169-050, Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, 4200-072, Portugal
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 050098, Romania
Institutul Oncologic Prof Dr Ion Chiricuta
Cluj-Napoca, 400015, Romania
Spitalul Clinic Municipal Filantropia Craiova
Craiova, 200143, Romania
Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550245, Romania
Narodny onkologicky ustav
Bratislava, 833 10, Slovakia
Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda
Bratislava, 851 07, Slovakia
Dong-A University Hospital
Busan, 49201, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Chungnam National University Hospital
Daejeon, 35015, South Korea
Chonnam National University Hwasun Hospital
Hwasun, 58128, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, 06591, South Korea
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004, Spain
Hospital Universitario Virgen del Rocio
Seville, Andalusia, 41013, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007, Spain
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, 08916, Spain
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, 08035, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, 08908, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, 46026, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Inselspital Bern
Bern, 3010, Switzerland
China Medical University Hospital
Taichung, 40458, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, 33305, Taiwan
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Memorial Antalya Hastanesi
Antalya, 07025, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, 34214, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
Izmir, 35340, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, 55139, Turkey (Türkiye)
University College London
London, NW1 2PG, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2021
First Posted
August 6, 2021
Study Start
November 2, 2021
Primary Completion (Estimated)
September 7, 2029
Study Completion (Estimated)
May 12, 2031
Last Updated
May 20, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
- Access Criteria
- Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request