Actively Recruiting
Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
Led by Amgen · Updated on 2026-05-08
304
Participants Needed
192
Research Sites
504 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.
CONDITIONS
Official Title
Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 years or older at the time of consent, OR age 40 to less than 55 years with at least one specified severe comorbidity such as history of severe pancreatitis, diabetes with organ damage, severe liver disease, or BMI of 40 or higher with related conditions
- Newly diagnosed Philadelphia-negative B-cell precursor acute lymphoblastic leukemia
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less, or higher if due to leukemia
- Adequate organ function including kidney function with estimated glomerular filtration rate of at least 50 mL/min/1.73 m²
- Liver function with total bilirubin less than or equal to twice the upper limit of normal, except for specified liver conditions in younger participants
- Cardiac function with left ventricular ejection fraction of 50% or higher and no uncontrolled cardiovascular disease
- Acceptable combination of severe comorbidities as judged compatible with the study treatment by the medical monitor
You will not qualify if you...
- Active central nervous system leukemia not resolved with intrathecal chemotherapy
- History of other malignancy within the past 3 years except for certain treated cancers without active disease
- Clinically relevant central nervous system conditions such as epilepsy, stroke, severe brain injuries, dementia, or psychiatric conditions that prevent corticosteroid use
- Current or history of autoimmune disease with possible CNS involvement
- Known infection with HIV
- Active or chronic infection with hepatitis B or C without required negative viral tests
- Symptoms or signs of acute or uncontrolled chronic infection
- Prior cancer chemotherapy for this leukemia before starting the study treatment except for intrathecal or optional pre-phase chemotherapy
- Radiation therapy only allowed for specific localized lesions for pain or stabilization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 192 locations
1
City of Hope National Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of California Irvine
Orange, California, United States, 92868-3201
Actively Recruiting
3
University of California San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
4
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
Orlando, Florida, United States, 32804
Terminated
5
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Terminated
6
Saint Francis Hospital, Inc
Greenville, South Carolina, United States, 29607
Completed
7
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Completed
8
Canberra Hospital
Garran, Australian Capital Territory, Australia, 2605
Actively Recruiting
9
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
10
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
11
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
12
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Terminated
13
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia, 4029
Actively Recruiting
14
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
15
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
16
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Completed
17
Austin Health, Austin Hospital
Heidelberg, Victoria, Australia, 3084
Actively Recruiting
18
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
19
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
20
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Actively Recruiting
21
Medizinische Universitaet Graz
Graz, Austria, 8036
Actively Recruiting
22
Medizinische Universitaet Innsbruck
Innsbruck, Austria, 6020
Completed
23
Ordensklinikum Linz Elisabethinen
Linz, Austria, 4020
Completed
24
Hanusch Krankenhaus
Vienna, Austria, 1140
Completed
25
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
26
AZ Sint-Jan Brugge-Oostende AV
Bruges, Belgium, 8000
Actively Recruiting
27
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Terminated
28
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
29
Universitair Ziekenhuis Gent
Ghent, Belgium, 9000
Actively Recruiting
30
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, Belgium, 3500
Actively Recruiting
31
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, Belgium, 4000
Actively Recruiting
32
AZ Delta Campus Rumbeke
Roeselare, Belgium, 8800
Actively Recruiting
33
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
Yvoir, Belgium, 5530
Actively Recruiting
34
Igesd Instituto de Gestao Estrategica da Saude do Distrito Federal
Brasília, Federal District, Brazil, 70335-902
Actively Recruiting
35
Hospital das Clinicas da Universidade Federal de Goias
Goiânia, Goiás, Brazil, 74605-020
Actively Recruiting
36
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Actively Recruiting
37
Fundacao Amaral Carvalho
Jaú, São Paulo, Brazil, 17210-120
Actively Recruiting
38
Hosp Clin Fac Med Ribeirao Preto Usp
Ribeirão Preto, São Paulo, Brazil, 14048-900
Actively Recruiting
39
Hospital de Base de Sao Jose do Rio Preto
São Jose Do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
40
Hemorio
Rio de Janeiro, Brazil, 22640-000
Actively Recruiting
41
Instituto Cancer Sao Paulo Icesp
São Paulo, Brazil, 01246-000
Actively Recruiting
42
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, Bulgaria, 40002
Actively Recruiting
43
Specialized Hospital for Active Treatment of Hematology Diseases EAD
Sofia, Bulgaria, 1797
Terminated
44
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
45
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
46
Cancer Care Manitoba
Winnipeg, Manitoba, Canada, R3H 0V9
Actively Recruiting
47
Queen Elizabeth II, Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V8
Actively Recruiting
48
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
49
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
50
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
51
CEMTL Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
52
Fundacion Arturo Lopez Perez
Santiago, Chile, 7500921
Actively Recruiting
53
Inmunocel
Santiago, Chile, 7580206
Actively Recruiting
54
Clinica Alemana de Santiago
Santiago, Chile, 7650729
Actively Recruiting
55
Fakultni nemocnice Brno
Brno, Czechia, 625 00
Actively Recruiting
56
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Actively Recruiting
57
Ustav hematologie a krevni transfuze
Prague, Czechia, 128 20
Actively Recruiting
58
Aalborg Universitetshospital
Aalborg, Denmark, 9000
Actively Recruiting
59
Aarhus Universitetshospital
Aarhus N, Denmark, 8200
Terminated
60
Rigshospitalet
København Ø, Denmark, 2100
Actively Recruiting
61
Odense Universitetshospital
Odense, Denmark, 5000
Actively Recruiting
62
North Estonia Medical Centre
Tallinn, Estonia, 13 419
Terminated
63
Tartu University Hospital
Tartu, Estonia, 51014
Terminated
64
Helsinki University Hospital
Helsinki, Finland, 00029
Actively Recruiting
65
Turku University Hospital
Turku, Finland, 20521
Actively Recruiting
66
Hopital Henri Mondor
Créteil, France, 94010
Actively Recruiting
67
Centre Hospitalier Universitaire de Dijon - Hopital du Bocage
Dijon, France, 21000
Actively Recruiting
68
Centre Hospitalier de Versailles - Hopital Andre Mignot
Le Chesnay, France, 78157
Actively Recruiting
69
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, France, 59000
Actively Recruiting
70
Institut Paoli Calmettes
Marseille, France, 13009
Actively Recruiting
71
Centre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu
Nantes, France, 44000
Actively Recruiting
72
Centre Hospitalier Universitaire Archet 2
Nice, France, 06202
Actively Recruiting
73
Hopital Saint Louis
Paris, France, 75010
Actively Recruiting
74
Hopital Saint Antoine
Paris, France, 75012
Terminated
75
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, France, 33604
Actively Recruiting
76
Hopital Lyon Sud
Pierre-Bénite, France, 69645
Actively Recruiting
77
Centre Hospitalier Universitaire de Rennes
Rennes, France, 35000
Actively Recruiting
78
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, France, 31059
Actively Recruiting
79
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
80
Universitaetsklinikum Augsburg
Augsburg, Germany, 86156
Completed
81
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, Germany, 12203
Completed
82
Universitaetsklinikum Dresden
Dresden, Germany, 01307
Completed
83
Universitaetsklinikum Duesseldorf
Düsseldorf, Germany, 40225
Completed
84
Universitaetsklinikum Heidelberg
Heidelberg, Germany, 69120
Completed
85
Universitaetsklinikum Jena
Jena, Germany, 07747
Completed
86
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, Germany, 24105
Completed
87
Klinikum der LMU Muenchen
München, Germany, 81377
Completed
88
Evangelismos Hospital
Athens, Greece, 10676
Actively Recruiting
89
Laiko General Hospital of Athens
Athens, Greece, 11527
Actively Recruiting
90
Attiko General University Hospital
Athens, Greece, 12462
Actively Recruiting
91
University Hospital of Heraklion
Heraklion, Greece, 71500
Actively Recruiting
92
University Hospital of Ioannina
Ioannina, Greece, 45500
Actively Recruiting
93
University Hospital of Larissa
Larissa, Greece, 41110
Actively Recruiting
94
University Hospital of Patras
Pátrai, Greece, 26504
Actively Recruiting
95
General Hospital of Thessaloniki Georgios Papanikolaou
Thessaloniki, Greece, 57010
Actively Recruiting
96
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
97
Princess Margaret Hospital
Kowloon, Hong Kong
Actively Recruiting
98
Tuen Mun Hospital
New Territories, Hong Kong
Actively Recruiting
99
Semmelweis Egyetem
Budapest, Hungary, 1088
Actively Recruiting
100
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, Hungary, 1097
Actively Recruiting
101
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Actively Recruiting
102
Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, Hungary, 3300
Terminated
103
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
Nyíregyháza, Hungary, 4400
Actively Recruiting
104
Rambam Medical Center
Haifa, Israel, 3109601
Actively Recruiting
105
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Actively Recruiting
106
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Israel, 4941492
Actively Recruiting
107
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, Italy, 70124
Terminated
108
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
Bergamo, Italy, 24127
Actively Recruiting
109
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna, Italy, 40138
Actively Recruiting
110
Ospedale Policlinico San Martino IRCCS
Genova, Italy, 16132
Actively Recruiting
111
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
Lecce, Italy, 73100
Terminated
112
Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo
Mestre (VE), Italy, 30174
Actively Recruiting
113
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
114
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Naples, Italy, 80131
Actively Recruiting
115
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, Italy, 06156
Actively Recruiting
116
Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito
Pescara, Italy, 65124
Actively Recruiting
117
Azienda Ospedaliera Policlinico Umberto I
Roma, Italy, 00161
Actively Recruiting
118
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Actively Recruiting
119
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
Verona, Italy, 37134
Terminated
120
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
Actively Recruiting
121
Akita University Hospital
Akita, Akita, Japan, 010-8543
Actively Recruiting
122
Tesshokai Kameda General Hospital
Kamogawa-shi, Chiba, Japan, 296-8602
Actively Recruiting
123
University of Fukui Hospital
Yoshida-gun, Fukui, Japan, 910-1193
Actively Recruiting
124
Kyushu University Hospital
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
125
Kurume University Hospital
Kurume-shi, Fukuoka, Japan, 830-0011
Actively Recruiting
126
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan, 960-1295
Actively Recruiting
127
Gunma Saiseikai Maebashi Hospital
Maebashi, Gunma, Japan, 371-0821
Actively Recruiting
128
Sapporo Hokuyu Hospital
Sapporo, Hokkaido, Japan, 003-0006
Actively Recruiting
129
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan, 650-0047
Actively Recruiting
130
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan, 920-8641
Actively Recruiting
131
Tokai University Hospital
Isehara-shi, Kanagawa, Japan, 259-1193
Actively Recruiting
132
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan, 232-0024
Actively Recruiting
133
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507
Actively Recruiting
134
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
135
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan, 852-8501
Actively Recruiting
136
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, Japan, 701-1192
Actively Recruiting
137
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan, 545-8586
Actively Recruiting
138
Kindai University Hospital
Sakai-shi, Osaka, Japan, 590-0197
Actively Recruiting
139
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan, 329-0498
Actively Recruiting
140
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, Japan, 113-8677
Actively Recruiting
141
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan, 173-8610
Actively Recruiting
142
Yamagata University Hospital
Yamagata, Yamagata, Japan, 990-9585
Actively Recruiting
143
Boca Clinical Trials Mexico SC
Mexico City, Mexico City, Mexico, 01120
Terminated
144
Centro Oncologico Internacional
Mexico City, Mexico City, Mexico, 01330
Actively Recruiting
145
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
146
Hematologica Alta Especialidad
Huixquilucan, Mexico, 52787
Actively Recruiting
147
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico, 14080
Actively Recruiting
148
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Active, Not Recruiting
149
Unidade Local de Saude de Coimbra, EPE
Coimbra, Portugal, 3004-561
Actively Recruiting
150
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, Portugal, 1099-023
Actively Recruiting
151
Unidade Local de Saude de Sao Jose, EPE - Hospital de Santo Antonio dos Capuchos
Lisbon, Portugal, 1169-050
Actively Recruiting
152
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, Portugal, 1649-035
Actively Recruiting
153
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, Portugal, 4200-072
Actively Recruiting
154
Institutul Clinic Fundeni
Bucharest, Romania, 022328
Actively Recruiting
155
Spitalul Universitar de Urgenta Bucuresti
Bucharest, Romania, 050098
Actively Recruiting
156
Institutul Oncologic Prof Dr Ion Chiricuta
Cluj-Napoca, Romania, 400015
Actively Recruiting
157
Spitalul Clinic Municipal Filantropia Craiova
Craiova, Romania, 200143
Actively Recruiting
158
Institutul Regional de Oncologie Iasi
Iași, Romania, 700483
Actively Recruiting
159
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, Romania, 550245
Actively Recruiting
160
Narodny onkologicky ustav
Bratislava, Slovakia, 833 10
Actively Recruiting
161
Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda
Bratislava, Slovakia, 851 07
Actively Recruiting
162
Dong-A University Hospital
Busan, South Korea, 49201
Actively Recruiting
163
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
164
Chungnam National University Hospital
Daejeon, South Korea, 35015
Actively Recruiting
165
Chonnam National University Hwasun Hospital
Hwasun, South Korea, 58128
Actively Recruiting
166
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
167
Severance Hospital Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
168
The Catholic University of Korea Seoul St Marys Hospital
Seoul, South Korea, 06591
Actively Recruiting
169
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain, 14004
Actively Recruiting
170
Hospital Universitario Virgen del Rocio
Seville, Andalusia, Spain, 41013
Terminated
171
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
172
Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain, 37007
Actively Recruiting
173
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain, 08916
Actively Recruiting
174
Hospital Universitari Vall d Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
175
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, Spain, 08908
Actively Recruiting
176
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain, 46026
Actively Recruiting
177
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Terminated
178
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden, 413 45
Actively Recruiting
179
Inselspital Bern
Bern, Switzerland, 3010
Active, Not Recruiting
180
China Medical University Hospital
Taichung, Taiwan, 40458
Actively Recruiting
181
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
182
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
183
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
184
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan, Taiwan, 33305
Actively Recruiting
185
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
186
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
187
Memorial Antalya Hastanesi
Antalya, Turkey (Türkiye), 07025
Actively Recruiting
188
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, Turkey (Türkiye), 34214
Actively Recruiting
189
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
Izmir, Turkey (Türkiye), 35340
Actively Recruiting
190
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, Turkey (Türkiye), 55139
Actively Recruiting
191
University College London
London, United Kingdom, NW1 2PG
Completed
192
Kings College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
A
Amgen Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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