Actively Recruiting
A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
Led by Amgen · Updated on 2026-05-01
281
Participants Needed
109
Research Sites
437 weeks
Total Duration
On this page
Sponsors
A
Amgen
Lead Sponsor
B
BeOne Medicines
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Phase IIC, Dose Escalation, and Dose Expansion: 18 years or older (or legal adult age in your country if higher).
- For Phase IIRa and IIMa: 17 years or older at consent.
- For Phase IIRb and IIMb: between 12 and less than 17 years at consent.
- Diagnosed with Relapsed or Refractory B-precursor ALL.
- Relapsed or Refractory B-precursor ALL after first salvage therapy.
- Relapsed B-precursor ALL after allogenic hematopoietic stem cell transplant.
- Bone marrow blasts 5% or higher for Ph-IIR, Ph-IIC, Dose escalation, and Dose expansion.
- Bone marrow blasts between 0.01% and less than 5% for Phase IIM.
- Availability of appropriate bone marrow samples for Phase IIM.
- ECOG performance status 0 to 2 for participants 18 years or older.
- Karnofsky score 50% or higher for ages 16 to under 18.
- Lansky score 50% or higher for under 16 years.
- Participants intolerant or refractory to prior tyrosine kinase inhibitors are eligible.
- For Phase IIM: Blood counts must meet minimum levels (ANC ≥ 500/μL, platelets ≥ 50,000/μL with transfusion allowed, hemoglobin ≥ 9 g/dL with transfusion allowed).
You will not qualify if you...
- Active leukemia in the central nervous system with clinical signs or cerebrospinal fluid involvement.
- History or presence of serious central nervous system disorders such as epilepsy, seizures, stroke, severe brain injuries, dementia, Parkinson's disease, psychosis, or severe neurotoxicity from prior treatments.
- Isolated extramedullary disease.
- For Phase IIM: presence of current extramedullary disease or circulating leukemia blasts.
- Current or history of autoimmune disease with risk of CNS involvement.
- Active graft versus host disease requiring immunosuppressive treatment.
- Acute or uncontrolled chronic infections or other conditions that could worsen with treatment.
- Testicular leukemia.
- History of other cancers within 3 years before starting study treatment (with some exceptions).
- Stem cell transplant within 12 weeks before study treatment.
- Recent chemotherapy within 2 weeks before study treatment (exceptions apply).
- Immunotherapy within 4 weeks before study treatment.
- Prior CD19-directed therapies allowed if treatment ended over 4 weeks ago with no CNS complications.
- Participation in other investigational studies within 30 days or 5 half-lives.
- Abnormal lab tests at screening.
- Pregnant or breastfeeding females or planning pregnancy during treatment and shortly after.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 109 locations
1
University of California San Francisco Fresno at Community Cancer Institute
Clovis, California, United States, 93611
Actively Recruiting
2
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
3
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
C.S. Mott Children's Hospital - University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Actively Recruiting
7
New York University Grossman School of Medicine and New York University Langone Hospitals
New York, New York, United States, 10016
Actively Recruiting
8
Albert Einstein College of Medicine - Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively Recruiting
9
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
St Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
11
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
12
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109-1023
Actively Recruiting
13
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109-1023
Completed
14
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
15
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
Actively Recruiting
16
Sanatorio Allende
Córdoba, Córdoba Province, Argentina, X5000JHQ
Actively Recruiting
17
Instituto Alexander Fleming
Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
18
Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno
Ciudad Autonoma Buenos Aires, Argentina, C1431FWO
Actively Recruiting
19
Sydney Childrens Hospital
Randwick, New South Wales, Australia, 2031
Actively Recruiting
20
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
21
Queensland Childrens Hospital
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
22
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
23
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
24
Austin Health, Austin Hospital
Heidelberg, Victoria, Australia, 3084
Terminated
25
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
26
Perth Childrens Hospital
Nedlands, Western Australia, Australia, 6909
Actively Recruiting
27
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, Austria, 1090
Completed
28
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
Yvoir, Belgium, 5530
Actively Recruiting
29
Hospital Sirio Libanes Brasilia
Brasília, Federal District, Brazil, 70200-730
Actively Recruiting
30
Instituto Medicina Integral Imip
Recife, Pernambuco, Brazil, 50070-902
Actively Recruiting
31
Hosp de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Actively Recruiting
32
Fundacao Amaral Carvalho
Jaú, São Paulo, Brazil, 17210-120
Actively Recruiting
33
Hosp Clin Fac Med Ribeirao Preto Usp
Ribeirão Preto, São Paulo, Brazil, 14048-900
Actively Recruiting
34
Instituto Onco Ped Graac Unifesp
São Paulo, São Paulo, Brazil, 04039-001
Actively Recruiting
35
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 2T9
Actively Recruiting
36
University of Alberta
Edmonton, Alberta, Canada, T6G 2P4
Actively Recruiting
37
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
38
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1E8
Actively Recruiting
39
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
40
Beijing Childrens Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
Actively Recruiting
41
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
42
Zhujiang Hospital of Southern Medical Unversity
Guangzhou, Guangdong, China, 510280
Actively Recruiting
43
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
44
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
45
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
46
Children's Hospital of Soochow University
Suzhou, Jiangsu, China, 215002
Actively Recruiting
47
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215031
Actively Recruiting
48
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Actively Recruiting
49
The First Affiliated Hospital Of Xi'An Jiaotong Unversity
Xi’an, Shanxi, China, 710061
Actively Recruiting
50
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
51
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
52
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
53
The Childrens Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
54
Centre Hospitalier de Versailles - Hopital Andre Mignot
Le Chesnay, France, 78157
Actively Recruiting
55
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, France, 59000
Actively Recruiting
56
Centre Hospitalier Universitaire de Nice - Hopital de l Archet
Nice, France, 06202
Actively Recruiting
57
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
58
Hopital Saint Antoine
Paris, France, 75012
Actively Recruiting
59
Hopital Robert Debre
Paris, France, 75019
Actively Recruiting
60
Hopital Lyon Sud
Pierre-Bénite, France, 69645
Actively Recruiting
61
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France, 31059
Actively Recruiting
62
Universitaetsklinikum Augsburg
Augsburg, Germany, 86156
Actively Recruiting
63
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12203
Actively Recruiting
64
Charite - Universitaetsmedizin Berlin, Campus Virchow
Berlin, Germany, 13353
Actively Recruiting
65
Universitaetsklinikum Koeln
Cologne, Germany, 50937
Actively Recruiting
66
Universitaetsklinikum Jena
Jena, Germany, 07747
Actively Recruiting
67
Universitaetsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
68
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72076
Completed
69
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
70
Universitatsklinikum Ulm
Ulm, Germany, 89081
Completed
71
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
72
Hong Kong Childrens Hospital
Kowloon Bay, Hong Kong
Actively Recruiting
73
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
74
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Israel, 4941492
Actively Recruiting
75
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
Bergamo, Italy, 24127
Actively Recruiting
76
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna, Italy, 40138
Actively Recruiting
77
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
78
Azienda Ospedaliero Universitaria Policlinico G Rodolico - San Marco Presidio Ospedaliero G Rodolico
Catania, Italy, 95123
Actively Recruiting
79
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Completed
80
Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon
Naples, Italy, 80123
Actively Recruiting
81
Azienda Ospedaliera Policlinico Umberto I
Roma, Italy, 00161
Actively Recruiting
82
IRCCS Ospedale Pediatrico Bambino Gesu
Roma, Italy, 00165
Actively Recruiting
83
Akita University Hospital
Akita, Akita, Japan, 010-8543
Actively Recruiting
84
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan, 277-8577
Actively Recruiting
85
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan, 960-1295
Actively Recruiting
86
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Actively Recruiting
87
Kanagawa Childrens Medical Center
Yokohami-shi, Kanagawa, Japan, 232-8555
Actively Recruiting
88
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 CN
Actively Recruiting
89
Prinses Maxima Centrum
Utrecht, Netherlands, 3584 CS
Actively Recruiting
90
Institutul Oncologic Prof Dr Ion Chiricuta
Cluj-Napoca, Romania, 400015
Actively Recruiting
91
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, South Korea, 58128
Actively Recruiting
92
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
93
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea, 06591
Actively Recruiting
94
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain, 41013
Completed
95
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
96
Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain, 37007
Actively Recruiting
97
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain, 08916
Actively Recruiting
98
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
99
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain, 08950
Actively Recruiting
100
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, Spain, 08908
Actively Recruiting
101
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008
Actively Recruiting
102
Hospital Clinico Universitario de Valencia
Valencia, Valencia, Spain, 46010
Actively Recruiting
103
Hospital Universitario Infantil Niño Jesus
Madrid, Spain, 28009
Actively Recruiting
104
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
105
Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi
Ankara, Turkey (Türkiye), 06010
Actively Recruiting
106
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
107
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, Turkey (Türkiye), 34214
Actively Recruiting
108
Istanbul Florence Nightingale Hastanesi
Istanbul, Turkey (Türkiye), 34214
Actively Recruiting
109
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, Turkey (Türkiye), 35575
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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