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A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
Sponsor: Amgen
Summary
The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.
Official title: A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
281
Start Date
2021-01-04
Completion Date
2029-05-25
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
Blinatumomab
Blinatumomab will be administered as a subcutaneous (SC) injection.
Locations (100)
City of Hope National Medical Center
Duarte, California, United States
University of Illinois Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
C.S. Mott Children's Hospital - University of Michigan
Ann Arbor, Michigan, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, United States
Albert Einstein College of Medicine - Montefiore Medical Center
The Bronx, New York, United States
St Jude Childrens Research Hospital
Memphis, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio Allende
Córdoba, Córdoba Province, Argentina
Instituto Alexander Fleming
Buenos Aires, Argentina
Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno
Ciudad Autonoma Buenos Aires, Argentina
Sydney Childrens Hospital
Randwick, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Queensland Childrens Hospital
South Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Austin Health, Austin Hospital
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
Yvoir, Belgium
Hospital Sirio Libanes Brasilia
Brasília, Federal District, Brazil
Instituto Medicina Integral Imip
Recife, Pernambuco, Brazil
Hosp 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
Instituto Onco Ped Graac Unifesp
São Paulo, São Paulo, Brazil
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
University of Alberta
Edmonton, Alberta, Canada
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Zhujiang Hospital of Southern Medical Unversity
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
The First Affiliated Hospital Of Xi'An Jiaotong Unversity
Xi’an, Shanxi, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Centre Hospitalier de Versailles - Hopital Andre Mignot
Le Chesnay, France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, France
Centre Hospitalier Universitaire de Nice - Hopital de l Archet
Nice, France
Hopital Saint Louis
Paris, France
Hopital Saint Antoine
Paris, France
Hopital Robert Debre
Paris, France
Hopital Lyon Sud
Pierre-Bénite, France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France
Universitaetsklinikum Augsburg
Augsburg, Germany
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, Germany
Universitaetsklinikum Koeln
Cologne, Germany
Universitaetsklinikum Jena
Jena, Germany
Universitaetsklinikum Leipzig
Leipzig, Germany
Universitaetsklinikum Tuebingen
Tübingen, Germany
Universitatsklinikum Ulm
Ulm, Germany
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Hong Kong Childrens Hospital
Kowloon Bay, Hong Kong
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
Bergamo, Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Italy
Azienda Ospedaliero Universitaria Policlinico G Rodolico - San Marco Presidio Ospedaliero G Rodolico
Catania, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon
Naples, Italy
Azienda Ospedaliera Policlinico Umberto I
Roma, Italy
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy
Akita University Hospital
Akita, Akita, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Kanagawa Childrens Medical Center
Yokohami-shi, Kanagawa, Japan
Erasmus Medisch Centrum
Rotterdam, Netherlands
Prinses Maxima Centrum
Utrecht, Netherlands
Institutul Oncologic Prof Dr Ion Chiricuta
Cluj-Napoca, Romania
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea
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 Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario Infantil Niño Jesus
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, Turkey (Türkiye)
Istanbul Florence Nightingale Hastanesi
Istanbul, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, Turkey (Türkiye)