RecruitingPhase 3NCT04994717

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)

Sponsor

Amgen

Enrollment

304 participants

Start Date

Nov 2, 2021

Study Type

INTERVENTIONAL

Conditions

Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

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.

Eligibility

Min Age: 40 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study compares a newer treatment approach alternating the immunotherapy blinatumomab with low-intensity chemotherapy versus the standard intensive chemotherapy regimen for older or less fit adults newly diagnosed with a specific type of blood cancer called Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL). **You may be eligible if...** - You are 55 or older with newly diagnosed Ph-negative B-cell ALL - Or you are 40–54 with significant health issues that make intensive chemotherapy too risky (e.g., severe pancreatitis history, diabetes with organ damage, severe liver disease, high BMI with metabolic syndrome) - Your general health status allows for treatment (ECOG ≤ 2) - You have adequate kidney, liver, and heart function **You may NOT be eligible if...** - You have active central nervous system leukemia (cancer in the brain or spinal fluid) - You have had another cancer in the past 3 years (with some exceptions) - You have a significant neurological condition (epilepsy, prior stroke, severe dementia) - You have an active autoimmune disease with CNS involvement - You have active HIV, hepatitis B, or hepatitis C - You have had cancer chemotherapy for this condition before joining the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBlinatumomab

Continuous intravenous (cIV) infusion

DRUGLow-intensity chemotherapy regimen

Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.

DRUGSOC chemotherapy regimen

Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.

Locations(192)

City of Hope National Medical Center

Duarte, California, United States

University of California Irvine

Orange, California, United States

University of California San Francisco

San Francisco, California, United States

Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando

Orlando, Florida, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Saint Francis Hospital, Inc

Greenville, South Carolina, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Canberra Hospital

Garran, Australian Capital Territory, Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Royal Brisbane and Womens Hospital

Herston, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Austin Health, Austin Hospital

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Medizinische Universitaet Graz

Graz, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Ordensklinikum Linz Elisabethinen

Linz, Austria

Hanusch Krankenhaus

Vienna, Austria

Institut Jules Bordet

Anderlecht, Belgium

AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Universite Catholique de Louvain Cliniques Universitaires Saint Luc

Brussels, Belgium

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Jessa Ziekenhuis - Campus Virga Jesse

Hasselt, Belgium

Centre Hospitalier Universitaire de Liege - Sart Tilman

Liège, Belgium

AZ Delta Campus Rumbeke

Roeselare, Belgium

Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne

Yvoir, Belgium

Igesd Instituto de Gestao Estrategica da Saude do Distrito Federal

Brasília, Federal District, Brazil

Hospital das Clinicas da Universidade Federal de Goias

Goiânia, Goiás, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Fundacao Amaral Carvalho

Jaú, São Paulo, Brazil

Hosp Clin Fac Med Ribeirao Preto Usp

Ribeirão Preto, São Paulo, Brazil

Hospital de Base de Sao Jose do Rio Preto

São Jose Do Rio Preto, São Paulo, Brazil

Hemorio

Rio de Janeiro, Brazil

Instituto Cancer Sao Paulo Icesp

São Paulo, Brazil

University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

Plovdiv, Bulgaria

Specialized Hospital for Active Treatment of Hematology Diseases EAD

Sofia, Bulgaria

Arthur J E Child Comprehensive Cancer Centre

Calgary, Alberta, Canada

Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre

Vancouver, British Columbia, Canada

Cancer Care Manitoba

Winnipeg, Manitoba, Canada

Queen Elizabeth II, Health Sciences Centre

Halifax, Nova Scotia, Canada

Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

Hamilton, Ontario, Canada

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

CEMTL Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

Fundacion Arturo Lopez Perez

Santiago, Chile

Inmunocel

Santiago, Chile

Clinica Alemana de Santiago

Santiago, Chile

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Ustav hematologie a krevni transfuze

Prague, Czechia

Aalborg Universitetshospital

Aalborg, Denmark

Aarhus Universitetshospital

Aarhus N, Denmark

Rigshospitalet

København Ø, Denmark

Odense Universitetshospital

Odense, Denmark

North Estonia Medical Centre

Tallinn, Estonia

Tartu University Hospital

Tartu, Estonia

Helsinki University Hospital

Helsinki, Finland

Turku University Hospital

Turku, Finland

Hopital Henri Mondor

Créteil, France

Centre Hospitalier Universitaire de Dijon - Hopital du Bocage

Dijon, France

Centre Hospitalier de Versailles - Hopital Andre Mignot

Le Chesnay, France

Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

Lille, France

Institut Paoli Calmettes

Marseille, France

Centre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu

Nantes, France

Centre Hospitalier Universitaire Archet 2

Nice, France

Hopital Saint Louis

Paris, France

Hopital Saint Antoine

Paris, France

Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

Pessac, France

Hopital Lyon Sud

Pierre-Bénite, France

Centre Hospitalier Universitaire de Rennes

Rennes, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

Vandœuvre-lès-Nancy, France

Universitaetsklinikum Augsburg

Augsburg, Germany

Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

Berlin, Germany

Universitaetsklinikum Dresden

Dresden, Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

Universitaetsklinikum Jena

Jena, Germany

Universitaetsklinikum Schleswig-Holstein - Kiel

Kiel, Germany

Klinikum der LMU Muenchen

München, Germany

Evangelismos Hospital

Athens, Greece

Laiko General Hospital of Athens

Athens, Greece

Attiko General University Hospital

Athens, Greece

University Hospital of Heraklion

Heraklion, Greece

University Hospital of Ioannina

Ioannina, Greece

University Hospital of Larissa

Larissa, Greece

University Hospital of Patras

Pátrai, Greece

General Hospital of Thessaloniki Georgios Papanikolaou

Thessaloniki, 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, Hungary

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary

Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet

Eger, Hungary

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

Nyíregyháza, Hungary

Rambam Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Israel

Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

Bari, Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii

Bergamo, Italy

IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

Bologna, Italy

Ospedale Policlinico San Martino IRCCS

Genova, Italy

Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

Lecce, Italy

Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo

Mestre (VE), Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

Naples, Italy

Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

Perugia, Italy

Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito

Pescara, Italy

Azienda Ospedaliera Policlinico Umberto I

Roma, Italy

Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino

Torino, Italy

Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma

Verona, Italy

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Akita University Hospital

Akita, Akita, Japan

Tesshokai Kameda General Hospital

Kamogawa-shi, Chiba, Japan

University of Fukui Hospital

Yoshida-gun, Fukui, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Kurume University Hospital

Kurume-shi, Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Gunma Saiseikai Maebashi Hospital

Maebashi, Gunma, Japan

Sapporo Hokuyu Hospital

Sapporo, Hokkaido, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo, Japan

Kanazawa University Hospital

Kanazawa, Ishikawa-ken, Japan

Tokai University Hospital

Isehara-shi, Kanagawa, Japan

Yokohama City University Medical Center

Yokohama, Kanagawa, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Nagasaki University Hospital

Nagasaki, Nagasaki, Japan

National Hospital Organization Okayama Medical Center

Okayama, Okayama-ken, Japan

Osaka Metropolitan University Hospital

Osaka, Osaka, Japan

Kindai University Hospital

Sakai-shi, Osaka, Japan

Jichi Medical University Hospital

Shimotsuke-shi, Tochigi, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyo-ku, Tokyo, Japan

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, Japan

Yamagata University Hospital

Yamagata, Yamagata, Japan

Boca Clinical Trials Mexico SC

Mexico City, Mexico City, Mexico

Centro Oncologico Internacional

Mexico City, Mexico City, Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Hematologica Alta Especialidad

Huixquilucan, Mexico

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Unidade Local de Saude de Coimbra, EPE

Coimbra, Portugal

Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

Lisbon, Portugal

Unidade Local de Saude de Sao Jose, EPE - Hospital de Santo Antonio dos Capuchos

Lisbon, Portugal

Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

Lisbon, Portugal

Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

Porto, Portugal

Institutul Clinic Fundeni

Bucharest, Romania

Spitalul Universitar de Urgenta Bucuresti

Bucharest, Romania

Institutul Oncologic Prof Dr Ion Chiricuta

Cluj-Napoca, Romania

Spitalul Clinic Municipal Filantropia Craiova

Craiova, Romania

Institutul Regional de Oncologie Iasi

Iași, Romania

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, Romania

Narodny onkologicky ustav

Bratislava, Slovakia

Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda

Bratislava, Slovakia

Dong-A University Hospital

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

The Catholic University of Korea Seoul St Marys Hospital

Seoul, South Korea

Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

Hospital Universitario Virgen del Rocio

Seville, Andalusia, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain

Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

L'Hospitalet de Llobregat, Catalonia, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Inselspital Bern

Bern, Switzerland

China Medical University Hospital

Taichung, Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Taoyuan, Taiwan

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye)

Memorial Antalya Hastanesi

Antalya, Turkey (Türkiye)

Bagcilar Medipol Mega Universite Hastanesi

Istanbul, Turkey (Türkiye)

Dokuz Eylul Universitesi Tip Fakultesi Hastanesi

Izmir, Turkey (Türkiye)

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

Samsun, Turkey (Türkiye)

University College London

London, United Kingdom

Kings College Hospital

London, United Kingdom

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NCT04994717