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Could a simple shot help fight tough leukemia?

NCT ID NCT04521231

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a subcutaneous (under the skin) injection of blinatumomab for people with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) or minimal residual disease. The goal is to see if this new method is safe and effective. About 181 adults and adolescents are taking part in this early-phase trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blinatumomab
What this could lead to
If successful, this could offer a more convenient, injectable version of blinatumomab for treating hard-to-control B-cell acute lymphoblastic leukemia.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so safety and effectiveness are not yet proven. Side effects may include serious immune reactions or infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

181 people

The number who actually took part.

Started

Jan 2021

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ph-IIC, Dose Escalation and Dose Expansion: Aged 18 years or older (or same or greater than legal age within the country if it is older than 18 years). * Ph-IIRa and Ph-IIMa: Aged ≥ 17 years at time of informed consent. * Ph-IIRb and Ph-IIMb: Age ≥ 12 years and \< 17 years at time of informed consent. * Ph-IIR, Ph-IIC, Dose escalation, Dose Expansion: Participants with R/R B-precursor ALL. * Relapsed or Refractory B-precursor ALL at any time after first salvage therapy. * Relapsed B-precursor ALL at any time after allogenic hematopoietic stem cell transplant (HSCT). * Ph-IIR, Ph-IIC, Dose escalation, Dose expansion: Greater than or equal to 5% blasts in the Bone Marrow per local assessment. * Ph-IIM: B-precursor ALL and bone marrow blasts (BMB) ≥ 0.01% and \< 5% per local assessment. * Ph-IIM: Availability of an appropriate archival BM specimen from initial or relapse diagnosis and the screening BM sample. * Participants aged ≥ 18 years: Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. * Participants aged 16 to \< 18 years old: Karnofsky Performance Score ≥ 50%. * Participants aged \< 16 years old: Lansky Performance Score ≥ 50%. * Any Ph+ participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible. * Ph-IIM: BM function as follows: * Absolute Neutrophil Count (ANC) ≥ 500/μL * Platelet count ≥ 50 000/μL (transfusion permitted) * Hemoglobin level ≥ 9 g/dL (transfusion permitted) The above is a summary, other inclusion criteria details may apply. Exclusion Criteria: * Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and/or clinical signs of CNS leukemia. If CSF leukemia is present subjects will have to receive intrathecal therapy and have documented negative CSF prior to enrolling. * History or presence of clinically relevant CNS pathology (excluding headache) such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (≥ grade 3) CNS events including immune effector cell-associated neurotoxicity syndrome (ICANS) from prior chimeric antigen receptor T-cell (CAR T) or other T cell engager therapies. * Isolated Extramedullary (EM) Disease. * For Ph-IIM only: Current EM disease or presence of circulating leukemia blasts. * Current autoimmune disease or history of autoimmune disease with potential CNS involvement. * Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication. * Symptoms and/or signs that indicate an acute or uncontrolled chronic infection, any other disease or condition that could be exacerbated by the treatment or would complicate protocol compliance. * Testicular leukemia. * History of malignancy (with certain exceptions) other than ALL within 3 years prior to start of protocol-specified therapy. * Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy. * Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy (with certain exceptions). * Immunotherapy within 4 weeks before start of protocol-specified therapy. * Prior failed cluster of differentiation (CD19) directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed (with demonstrated continued CD19+ expression), if treatment ended more than 4 weeks prior to start of protocol therapy and no prior CNS complications. * Currently receiving treatment in or less than 30 days or 5 half-lives since ending treatment on another investigational study(ies). * Abnormal screening laboratory parameters. * Female participant: Pregnant or breastfeeding or planning to become pregnant or donate eggs, or expected to breastfeed during treatment and for 96 hours after the last dose of investigational product (SC blinatumomab). The above is a summary, other exclusion criteria details may apply.

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Conditions

The condition(s) this trial relates to.

B-cell acute lymphoblastic leukemia Neoplasm, Residual precursor B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B cell precursor acute lymphoblastic leukemia

Contacts and locations

Locations

  • Akita University Hospital

    Akita, Akita, 010-8543, Japan

  • Albert Einstein College of Medicine - Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800, Turkey (Türkiye)

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 2T9, Canada

  • Austin Health, Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliera Policlinico Umberto I

    Roma, 00161, Italy

  • Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

    Naples, 80123, Italy

  • Azienda Ospedaliero Universitaria Policlinico G Rodolico - San Marco Presidio Ospedaliero G Rodolico

    Catania, 95123, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii

    Bergamo, 24127, Italy

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214, Turkey (Türkiye)

  • Beijing Childrens Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045, China

  • C.S. Mott Children's Hospital - University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno

    Ciudad Autonoma Buenos Aires, C1431FWO, Argentina

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    Lille, 59000, France

  • Centre Hospitalier Universitaire de Nice - Hopital de l Archet

    Nice, 06202, France

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

    Yvoir, 5530, Belgium

  • Centre Hospitalier de Versailles - Hopital Andre Mignot

    Le Chesnay, 78157, France

  • Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12203, Germany

  • Charite - Universitaetsmedizin Berlin, Campus Virchow

    Berlin, 13353, Germany

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu, 215002, China

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, 58128, South Korea

  • Christus Centro de Excelencia en Investigacion

    Monterrey, Nuevo León, 64060, Mexico

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008, Spain

  • Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca

    Salamanca, Castille and León, 37007, Spain

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CN, Netherlands

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109-1023, United States

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295, Japan

  • Fundacao Amaral Carvalho

    Jaú, São Paulo, 17210-120, Brazil

  • Health Pharma Queretaro Sa de Cv

    Querétaro, 76230, Mexico

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Hong Kong Childrens Hospital

    Kowloon Bay, Hong Kong

  • Hopital Lyon Sud

    Pierre-Bénite, 69645, France

  • Hopital Robert Debre

    Paris, 75019, France

  • Hopital Saint Antoine

    Paris, 75012, France

  • Hopital Saint Louis

    Paris, 75010, France

  • Hosp Clin Fac Med Ribeirao Preto Usp

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Hosp de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010, Spain

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, Catalonia, 08950, Spain

  • Hospital Sirio Libanes Brasilia

    Brasília, Federal District, 70200-730, Brazil

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Infantil Niño Jesus

    Madrid, 28009, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013, Spain

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

    Bologna, 40138, Italy

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165, Italy

  • IRCCS Ospedale San Raffaele

    Milan, 20132, Italy

  • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

    Badalona, Catalonia, 08916, Spain

  • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalonia, 08908, Spain

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059, France

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020, China

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020, China

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ, Argentina

  • Instituto Medicina Integral Imip

    Recife, Pernambuco, 50070-902, Brazil

  • Instituto Onco Ped Graac Unifesp

    São Paulo, São Paulo, 04039-001, Brazil

  • Institutul Oncologic Prof Dr Ion Chiricuta

    Cluj-Napoca, 400015, Romania

  • Istanbul Florence Nightingale Hastanesi

    Istanbul, 34214, Turkey (Türkiye)

  • Izmir Ekonomi Universitesi Medical Point Hastanesi

    Izmir, 35575, Turkey (Türkiye)

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

  • Kanagawa Childrens Medical Center

    Yokohami-shi, Kanagawa, 232-8555, Japan

  • Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • New York University Grossman School of Medicine and New York University Langone Hospitals

    New York, New York, 10016, United States

  • Perth Childrens Hospital

    Nedlands, Western Australia, 6909, Australia

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Prinses Maxima Centrum

    Utrecht, 3584 CS, Netherlands

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong, Hong Kong

  • Queensland Childrens Hospital

    South Brisbane, Queensland, 4101, Australia

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010, Turkey (Türkiye)

  • Sanatorio Allende

    Córdoba, Córdoba Province, X5000JHQ, Argentina

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • St Jude Childrens Research Hospital

    Memphis, Tennessee, 38105, United States

  • Sydney Childrens Hospital

    Randwick, New South Wales, 2031, Australia

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003, China

  • The Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The Childrens Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310005, China

  • The First Affiliated Hospital Of Xi'An Jiaotong Unversity

    Xi’an, Shanxi, 710061, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215031, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1E8, Canada

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090, Austria

  • Universitaetsklinikum Augsburg

    Augsburg, 86156, Germany

  • Universitaetsklinikum Jena

    Jena, 07747, Germany

  • Universitaetsklinikum Koeln

    Cologne, 50937, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076, Germany

  • Universitatsklinikum Ulm

    Ulm, 89081, Germany

  • University of Alberta

    Edmonton, Alberta, T6G 2P4, Canada

  • University of California San Francisco Fresno at Community Cancer Institute

    Clovis, California, 93611, United States

  • University of Illinois Chicago

    Chicago, Illinois, 60612, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024, Japan

  • Zhujiang Hospital of Southern Medical Unversity

    Guangzhou, Guangdong, 510280, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.