RecruitingPhase 1Phase 2NCT04521231

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL

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

Sponsor

Amgen

Enrollment

281 participants

Start Date

Jan 4, 2021

Study Type

INTERVENTIONAL

Conditions

B Cell Precursor Acute Lymphoblastic Leukemia

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.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new form of blinatumomab — given as an injection under the skin instead of through a vein — for people with a type of blood cancer called B-cell acute lymphoblastic leukemia (B-ALL) that has either come back or stopped responding to treatment. **You may be eligible if...** - You are 12 years or older (age requirements vary by study phase) - You have been diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) - Your leukemia has relapsed (come back) or is refractory (not responding to treatment) - In some parts of the study: your leukemia shows minimal residual disease (tiny amounts of cancer still detectable after treatment) **You may NOT be eligible if...** - You have active cancer in the central nervous system - You have had a stem cell transplant too recently - You have significant organ dysfunction 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

Blinatumomab will be administered as a subcutaneous (SC) injection.

Locations(109)

University of California San Francisco Fresno at Community Cancer Institute

Clovis, California, United States

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

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, 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

Perth Childrens Hospital

Nedlands, Western Australia, 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

Beijing Childrens Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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

The Childrens Hospital, 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

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

Rambam Medical Center

Haifa, Israel

Rabin Medical Center - Beilinson Hospital

Petah Tikva, Israel

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 Universitari Vall d Hebron

Barcelona, 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)

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NCT04521231