AzTrials
AzTrials

B Cell Precursor Acute Lymphoblastic LeukemiaPhase 1/2NCT04521231

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

A Phase 1/2 study testing Blinatumomab in people with B Cell Precursor Acute Lymphoblastic Leukemia, run by Amgen at 109 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
Blinatumomab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
181 participants
Where
109 sitesin 20 countries
Study dates
4 Jan 2021to 25 May 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).
Show all 18Show fewer
  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

109 sites in 20 countries.

109 sites in 20 countries

China14 sites

  • Beijing Childrens Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Zhujiang Hospital of Southern Medical Unversity

    Guangzhou, Guangdong, 510280

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The Childrens Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310005

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu, 215002

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215031

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

    Tianjin, Tianjin Municipality, 300020

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

    Tianjin, Tianjin Municipality, 300020

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

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital Of Xi'An Jiaotong Unversity

    Xi’an, Shanxi, 710061

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

United States13 sites

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

    Ann Arbor, Michigan, 48109

  • Johns Hopkins University

    Baltimore, Maryland, 21287

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

  • University of Illinois Chicago

    Chicago, Illinois, 60612

  • University of California San Francisco Fresno at Community Cancer Institute

    Clovis, California, 93611

  • City of Hope National Medical Center

    Duarte, California, 91010

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • St Jude Childrens Research Hospital

    Memphis, Tennessee, 38105

  • The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

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

    New York, New York, 10016

  • Childrens Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109-1023

  • Albert Einstein College of Medicine - Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Spain11 sites

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

    Badalona, Catalonia, 08916

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, Catalonia, 08950

  • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalonia, 08908

  • Hospital Universitario Infantil Niño Jesus

    Madrid, 28009

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca

    Salamanca, Castille and León, 37007

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio

    Seville, Andalusia, 41013

  • Hospital Clinico Universitario de Valencia

    Valencia, Valencia, 46010

Other trials in Spain

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Austin Health, Austin Hospital

    Heidelberg, Victoria, 3084

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Perth Childrens Hospital

    Nedlands, Western Australia, 6909

  • Sydney Childrens Hospital

    Randwick, New South Wales, 2031

  • Queensland Childrens Hospital

    South Brisbane, Queensland, 4101

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

France8 sites

  • Centre Hospitalier de Versailles - Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    Lille, 59000

  • Centre Hospitalier Universitaire de Nice - Hopital de l Archet

    Nice, 06202

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Saint Antoine

    Paris, 75012

  • Hopital Robert Debre

    Paris, 75019

  • Hopital Lyon Sud

    Pierre-Bénite, 69645

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059

Other trials in France

Germany8 sites

  • Universitaetsklinikum Augsburg

    Augsburg, 86156

  • Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12203

  • Charite - Universitaetsmedizin Berlin, Campus Virchow

    Berlin, 13353

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Universitaetsklinikum Jena

    Jena, 07747

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Universitaetsklinikum Tuebingen

    Tübingen, 72076

  • Universitatsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Italy8 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii

    Bergamo, 24127

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

    Bologna, 40138

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    Brescia, 25123

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

    Catania, 95123

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon

    Naples, 80123

  • Azienda Ospedaliera Policlinico Umberto I

    Roma, 00161

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Roma, 00165

Other trials in Italy

Brazil6 sites

  • Hospital Sirio Libanes Brasilia

    Brasília, Federal District, 70200-730

  • Fundacao Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Hosp de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Instituto Medicina Integral Imip

    Recife, Pernambuco, 50070-902

  • Hosp Clin Fac Med Ribeirao Preto Usp

    Ribeirão Preto, São Paulo, 14048-900

  • Instituto Onco Ped Graac Unifesp

    São Paulo, São Paulo, 04039-001

Other trials in Brazil

Canada5 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 2T9

  • University of Alberta

    Edmonton, Alberta, T6G 2P4

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1E8

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

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

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Japan5 sites

  • Akita University Hospital

    Akita, Akita, 010-8543

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • Kanagawa Childrens Medical Center

    Yokohami-shi, Kanagawa, 232-8555

Other trials in Japan

Turkey (Türkiye)5 sites

  • Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi

    Ankara, 06010

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Istanbul Florence Nightingale Hastanesi

    Istanbul, 34214

  • Izmir Ekonomi Universitesi Medical Point Hastanesi

    Izmir, 35575

Other trials in Turkey (Türkiye)

Argentina4 sites

  • Instituto Alexander Fleming

    Buenos Aires, C1426ANZ

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

    Ciudad Autonoma Buenos Aires, C1431FWO

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB

  • Sanatorio Allende

    Córdoba, Córdoba Province, X5000JHQ

Other trials in Argentina

South Korea3 sites

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Hong Kong2 sites

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

  • Hong Kong Childrens Hospital

    Kowloon Bay

Other trials in Hong Kong

Israel2 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4941492

Other trials in Israel

Mexico2 sites

  • Christus Centro de Excelencia en Investigacion

    Monterrey, Nuevo León, 64060

  • Health Pharma Queretaro Sa de Cv

    Querétaro, 76230

Other trials in Mexico

Netherlands2 sites

  • Erasmus Medisch Centrum

    Rotterdam, 3015 CN

  • Prinses Maxima Centrum

    Utrecht, 3584 CS

Other trials in Netherlands

Austria1 site

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, 1090

Other trials in Austria

Belgium1 site

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

    Yvoir, 5530

Other trials in Belgium

Romania1 site

  • Institutul Oncologic Prof Dr Ion Chiricuta

    Cluj-Napoca, 400015

Other trials in Romania

About this study

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

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.

Being tested
Blinatumomab
Keywords
R/R B-ALL, MRD+ B-ALL, Relapsed, Refractory, Minimal Residual Disease, AMG 103, Blinatumomab, Acute lymphoblastic leukemia, Adolescent, Adult
Medical subject headings
Recurrence, Neoplasm, Residual, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BlinatumomabDrug

    Also called AMG 103

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

Study groups in NCT04521231
Study groupRoleWhat they receive
Dose Escalation Phase: Blinatumomab Subcutaneous Formulation 1 (SC1)ExperimentalCohorts of at least 3 adult participants with R/R B-ALL will be treated with escalating doses of blinatumomab to determine the maximum tolerated dose (MTD). The MTD will be defined as the dose for which the estimate of the toxicity rate from an isotonic regression (Yan et al, 2017) is closest to the target toxicity rate. Safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy will be assessed.
Receives: Drug: Blinatumomab
Dose Expansion Phase: Blinatumomab SC1ExperimentalUp to 4 cohorts of adult participants with R/R B-ALL will be enrolled at different dose levels to support identification of the RP2D. Each cohort will aim to further assess safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy.
Receives: Drug: Blinatumomab
Ph-IIC: Clinical PK Evaluation of SC Blinatumomab FormulationsExperimental1 cohort of adult participants will be enrolled into the Ph-IIC arm. The clinical PK evaluation cohort (Ph-IIC) will be conducted to compare the PK of SC1 and SC2 formulations at the preliminary RP2D determined from the dose expansion phase, in participants with R/R B-ALL.
Receives: Drug: Blinatumomab
Ph-IIR: Efficacy of SC Blinatumomab in Participants with R/R B-ALLExperimentalThe efficacy of SC blinatumomab (in the SC2 formulation) will be evaluated in adults and adolescents with R/R B-ALL.
Receives: Drug: Blinatumomab
Ph-IIM: Efficacy of SC Blinatumomab in Participants with MRD+ B-ALLExperimentalThe efficacy of SC blinatumomab (in the SC2 formulation) will be evaluated in adults and adolescents with MRD+ B-ALL.
Receives: Drug: Blinatumomab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs)

    Measured: Up to 29 days

  2. Dose Escalation Phase: Number of participants who experience one or more treatment-emergent adverse events (TEAEs)

    Measured: Up to approximately 28 weeks

  3. Dose Escalation Phase: Number of participants who experience one or more serious TEAEs

    Measured: Up to approximately 28 weeks

  4. Dose Escalation Phase: Number of participants who experience one or more treatment-related TEAEs

    Measured: Up to approximately 28 weeks

  5. Dose Escalation Phase: Number of participants who experience one or more adverse events (AEs) of Interest (AEIs)

    Measured: Up to approximately 28 weeks

  6. Dose Expansion and Phase 2 Ph-IIR cohort: Number of participants who achieve complete remission (CR) / complete remission with partial hematological recovery (CRh)

    Measured: Up to 10 weeks

  7. Phase 2 Ph-IIC cohort: Maximum concentration (Cmax) of blinatumomab SC1 and SC2

    Measured: Up to approximately 4 weeks

  8. Phase 2 Ph-IIC cohort: Average concentration (Cavg) of blinatumomab SC1 and SC2

    Measured: Up to approximately 4 weeks

  9. Phase 2 Ph-IIC cohort: Time to reach maximum concentration (Tmax) of blinatumomab SC1 and SC2

    Measured: Up to approximately 4 weeks

  10. Phase 2 Ph-IIC cohort: Area under the concentration-time curve (AUC) of blinatumomab SC1 and SC2

    Measured: Up to approximately 4 weeks

  11. Phase 2 Ph-IIM cohort: Number of participants who achieve CR with MRD-negative response

    Measured: Up to 10 weeks

Secondary outcomes (28)

  1. Dose Escalation and Dose Expansion Phase: Minimum concentration over the dosing interval (Cmin) of blinatumomab

    Measured: Up to approximately 10 weeks

  2. Dose Escalation and Dose Expansion Phase: Cmax of blinatumomab

    Measured: Up to approximately 10 weeks

  3. Dose Escalation and Dose Expansion Phase: Tmax of blinatumomab

    Measured: Up to approximately 10 weeks

  4. Dose Escalation and Dose Expansion Phase: AUC of blinatumomab

    Measured: Up to approximately 10 weeks

  5. Dose Escalation Phase and Phase 2 (Ph-IIC cohort): Number of participants who achieve CR/CRh

    Measured: Up to 10 weeks

  6. Dose Escalation Phase, Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Number of participants with incidence of anti-blinatumomab antibody formation

    Measured: Up to approximately 28 weeks

  7. Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Overall survival (OS)

    Measured: Up to approximately 2 years

  8. Dose Expansion Phase and Phase 2 (Ph-IIR cohort and Ph-IIC cohort): Duration of response

    Measured: Up to approximately 2 years

  9. Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Relapse free survival

    Measured: Up to approximately 2 years

  10. Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Number of participants who experience one or more TEAEs

    Measured: Up to approximately 28 weeks

  11. Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Number of participants who experience one or more serious treatment-emergent adverse event

    Measured: Up to approximately 2 years

  12. Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Number of participants who experience one or more treatment-related treatment-emergent adverse events

    Measured: Up to approximately 28 weeks

  13. Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Number of participants who experience one or more AEIs

    Measured: Up to approximately 28 weeks

  14. Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Summary scores of quality of life at each assessment as assessed by the EORTC QLQ-C30 for participants aged ≥ 17 years at the time of consent

    The EORTC QLQ-C30 is defined as the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire.

    Measured: Baseline (Day 1) up to approximately 28 weeks

  15. Dose Expansion Phase and Phase 2 (Ph-IIR cohort, Ph-IIM cohort and Ph-IIC cohort): Change from baseline of quality of life as assessed by the EORTC QLQ-C30 for participants aged ≥ 17 years at the time of consent

    Measured: Baseline (Day 1) up to approximately 28 weeks

  16. Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Summary scores of quality of life at each assessment as assessed by PedsQL Generic Core Scale for participants aged 12 to < 17 years at time of consent

    Measured: Baseline (Day 1) up to approximately 28 weeks

  17. Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Change from baseline of quality of life as assessed by PedsQL Generic Core Scale for participants aged 12 to < 17 years at time of consent

    Measured: Baseline (Day 1) up to approximately 28 weeks

  18. Phase 2 (Ph-IIR cohort): Number of participants who achieve CR

    Measured: Up to 10 weeks

  19. Phase 2 (Ph-IIR cohort): Number of participants who achieve CR, CRh, CRi (complete remission with incomplete hematological recovery) or blast free hypoplastic or aplastic bone marrow (BM)

    Measured: Up to 10 weeks

  20. Phase 2 (Ph-IIM cohort): Number of participants who achieve CR, CRh, CRi or blast free hypoplastic or aplastic BM with MRD-negative response

    Measured: Up to 10 weeks

  21. Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Number of participants who achieve CR or CRh with MRD-negative response

    Measured: Up to 10 weeks

  22. Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Duration of molecular response

    Measured: Up to approximately 2 years

  23. Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Cmax of blinatumomab for participants participating in intense PK sampling assessment

    Measured: Up to approximately 4 weeks

  24. Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Tmax of blinatumomab for participants participating in intense PK sampling assessment

    Measured: Up to approximately 4 weeks

  25. Phase 2 (Ph-IIR cohort and Ph-IIM cohort): AUC of blinatumomab for participants participating in intense PK sampling assessment

    Measured: Up to approximately 4 weeks

  26. Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Blinatumomab serum concentrations for participants not participating in intense PK sampling assessment

    Measured: Up to approximately 4 weeks

  27. Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Proportion of time on treatment with high side effect bother from baseline to end of treatment as measured by Functional Assessment of Chronic Illness Therapy (FACIT) GP5 item for participants aged ≥ 17 years

    This endpoint applies to participants aged ≥ 17 years at time of consent.

    Measured: Baseline (Day 1) up to approximately 28 weeks

  28. Phase 2 (Ph-IIR cohort and Ph-IIM cohort): Pain difference between pain score before and after injection as reported using the Numeric Rating Scale (NRS-11) for participants aged 12 to < 17 years at time of consent

    Measured: Up to approximately 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start4 Jan 2021
  3. Primary completion24 Nov 2027 (estimated)
  4. Study completion25 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
181 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04521231
Sponsor's protocol ID
20180257
Other IDs
2023-506136-32, 2023
Status last verified
May 2026
First submitted
18 Aug 2020
Last updated
28 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • Jabbour E, Zugmaier G, Agrawal V, Martinez-Sanchez P, Rifon Roca JJ, Cassaday RD, Boll B, Rijneveld A, Abdul-Hay M, Huguet F, Cluzeau T, Diaz MT, Vucinic V, Gonzalez-Campos J, Rambaldi A, Schwartz S, Berthon C, Hernandez-Rivas JM, Gordon PR, Bruggemann M, Hamidi A, Chen Y, Wong HL, Panwar B, Katlinskaya Y, Markovic A, Kantarjian H. Single agent subcutaneous blinatumomab for advanced acute lymphoblastic leukemia. Am J Hematol. 2024 Apr;99(4):586-595. doi: 10.1002/ajh.27227. Epub 2024 Feb 5.

    PubMed 38317420

  • Jabbour E, Lussana F, Martinez-Sanchez P, Torrent A, Rifon JJ, Agrawal V, Tormo M, Cassaday RD, Cluzeau T, Huguet F, Papayannidis C, Hernandez-Rivas JM, Rijneveld A, Fleming S, Vucinic V, Boll B, Ikezoe T, Abdul-Hay M, Savoie ML, Schuh AC, Berthon C, Schwartz S, Chiaretti S, Yuda J, Miyazaki T, Gonzalez-Campos J, Chen Y, Wong H, Choudhry J, Zugmaier G, Guest E, Gordon P, Kantarjian H. Subcutaneous blinatumomab in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia: post-hoc safety and activity analysis from a multicentre, single-arm, phase 1/2 trial. Lancet Haematol. 2025 Jul;12(7):e529-e541. doi: 10.1016/S2352-3026(25)00144-9. Epub 2025 Jun 15.

    PubMed 40532723

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Blinatumomab in people with B Cell Precursor Acute Lymphoblastic Leukemia, run by Amgen at 109 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in China, United States, Spain, Australia, France and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Escalation Phase: Number of participants who experience dose limiting toxicities (DLTs) (time frame: Up to 29 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04521231, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in