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
NCT ID: NCT04994717
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
304 participants
INTERVENTIONAL
2021-11-02
2031-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Safety Run-in: Blinatumomab alternating with low-intensity chemotherapy
The safety run-in will be performed prior to initiating the phase 3 randomized part of the study. This safety run-in is to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy.
The safety run-in also evaluates a shorter dose step interval from (4 days instead of 7 days) and a 1-week (instead of 2-week) drug free interval between blinatumomab cycles. Blinatumomab will be infused at a lower dose for 4 days and increase to a higher dose on Day 5 of the infusion for the remainder of the infusion.
Blinatumomab
Continuous intravenous (cIV) infusion
Low-intensity chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Phase 3: Blinatumomab alternating with low-intensity chemotherapy
Participants will receive blinatumomab alternating with low-intensity chemotherapy.
Blinatumomab
Continuous intravenous (cIV) infusion
Low-intensity chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Phase 3: Standard of care (SOC) chemotherapy
Participants will receive 1 of 2 SOC chemotherapy regimens (GMALL or HyperCVAD) per investigator's choice.
SOC chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Interventions
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Blinatumomab
Continuous intravenous (cIV) infusion
Low-intensity chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
SOC chemotherapy regimen
Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Age 40 to \< 55 years of age if at least 1 of the following comorbidities at the time of informed consent:
* history of grades 3 and 4 pancreatitis
* diabetes mellitus with end-organ damage
* severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and aspartate transaminase (AST)/alanine aminotransferase (ALT) \> 10 x upper limit of normal (ULN) (liver cirrhosis must be confirmed by biopsy)
* body mass index (BMI) ≥ 40 combined with relevant comorbidities such as metabolic syndrome
* Any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric based, adult adapted standard chemotherapy regimen but still compatible with the suggested protocol for older participants in both the experimental and the SOC arm. The participant history will be reviewed by the medical monitor during screening to determine enrollment acceptability based on a standard list with types of comorbidities allowed.
* Participants with newly diagnosed Philadelphia (Ph)-negative B-cell precursor acute lymphoblastic leukemia (ALL)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, higher ECOG score allowed if due to underlying leukemia
* All participants must have adequate organ function as defined below:
* renal: estimated glomerular filtration rate based on MDRD calculation ≥ 50 mL/min/1.73 m\^2
* liver function: total bilirubin ≤ 2x upper limit of normal (ULN; unless Gilbert's Disease or if liver involvement with leukemia); exception for participants 40 to \< 55 years of age if they have a comorbidity listed above: severe liver disease such as cirrhosis stage 2 with portal hypertension or history of esophageal variceal bleeding and AST/ALT \> 10 x ULN (liver cirrhosis must be confirmed by biopsy)
* cardiac: left ventricular ejection fraction (LVEF) ≥ 50% and no clinically significant, uncontrolled, or active cardiovascular disease (eg, myocardial infarction or stroke within 3 months). Consult with medical monitor as needed.
Exclusion Criteria
* History of other malignancy within the past 3 years, with the following exceptions:
* Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
* Adequately treated cervical carcinoma in situ without evidence of disease
* Adequately treated breast ductal carcinoma in situ without evidence of disease
* Prostatic intraepithelial neoplasia without evidence of prostate cancer
* Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
* Clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric conditions that preclude the use of high dose of corticosteroids
* Current autoimmune disease or history of autoimmune disease with potential CNS involvement
* Known infection with human immunodeficiency virus (HIV)
* Known infection with chronic or active infection with hepatitis B (eg, hepatitis b surface \[HBs\] antigen reactive or quantifiable hepatitis b virus \[HBV\] viral load) or hepatitis C virus (HCV) (eg, HCV RNA \[qualitative\] is detected).
Active hepatitis B and C based on the following results:
* positive for hepatitis B surface antigen (HepBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B)
* negative HepBsAg and positive for hepatitis B core antibody: negative HBV DNA by PCR result is necessary to enroll.
* positive Hepatitis C virus antibody (HepCAb): negative hepatitis C virus RNA by PCR result is necessary to enroll.
* Participant with symptoms and/or clinical signs and/or radiographic and/or sonographic signs that indicate an acute or uncontrolled chronic infection.
* Cancer chemotherapy for this newly diagnosed B cell ALL before the start of protocol-required therapy with the exception of IT chemotherapy or optional pre-phase (debulking) chemotherapy. Radiation to a spot lesion such as chloroma or lytic lesion of bone or vertebrae for pain or vertebral stabilization is allowed.
40 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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City of Hope National Medical Center
Duarte, California, United States
University of California Irvine
Orange, California, United States
University of California San Francisco
San Francisco, California, United States
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
Orlando, Florida, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Saint Francis Hospital, Inc
Greenville, South Carolina, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Canberra Hospital
Garran, Australian Capital Territory, Australia
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Austin Health, Austin Hospital
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Medizinische Universitaet Graz
Graz, , Austria
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
Ordensklinikum Linz Elisabethinen
Linz, , Austria
Hanusch Krankenhaus
Vienna, , Austria
Institut Jules Bordet
Anderlecht, , Belgium
AZ Sint-Jan Brugge-Oostende AV
Bruges, , Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Jessa Ziekenhuis - Campus Virga Jesse
Hasselt, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
AZ Delta Campus Rumbeke
Roeselare, , Belgium
Centre Hospitalier Universitaire-Universite Catholique de Louvain Namur-Site Godinne
Yvoir, , Belgium
Igesd Instituto de Gestao Estrategica da Saude do Distrito Federal
Brasília, Federal District, Brazil
Hospital das Clinicas da Universidade Federal de Goias
Goiânia, Goiás, Brazil
Hospital 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
Hospital de Base de Sao Jose do Rio Preto
São Jose Do Rio Preto, São Paulo, Brazil
Hemorio
Rio de Janeiro, , Brazil
Instituto Cancer Sao Paulo Icesp
São Paulo, , Brazil
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD
Plovdiv, , Bulgaria
Specialized Hospital for Active Treatment of Hematology Diseases EAD
Sofia, , Bulgaria
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Queen Elizabeth II, Health Sciences Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CEMTL Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Fundacion Arturo Lopez Perez
Santiago, , Chile
Inmunocel
Santiago, , Chile
Clinica Alemana de Santiago
Santiago, , Chile
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Ustav hematologie a krevni transfuze
Prague, , Czechia
Aalborg Universitetshospital
Aalborg, , Denmark
Aarhus Universitetshospital
Aarhus N, , Denmark
Rigshospitalet
København Ø, , Denmark
Odense Universitetshospital
Odense, , Denmark
North Estonia Medical Centre
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
Helsinki University Hospital
Helsinki, , Finland
Turku University Hospital
Turku, , Finland
Hopital Henri Mondor
Créteil, , France
Centre Hospitalier Universitaire de Dijon - Hopital du Bocage
Dijon, , France
Centre Hospitalier de Versailles - Hopital Andre Mignot
Le Chesnay, , France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
Lille, , France
Institut Paoli Calmettes
Marseille, , France
Centre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu
Nantes, , France
Centre Hospitalier Universitaire Archet 2
Nice, , France
Hopital Saint Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque
Pessac, , France
Hopital Lyon Sud
Pierre-Bénite, , France
Centre Hospitalier Universitaire de Rennes
Rennes, , France
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, , France
Universitaetsklinikum Augsburg
Augsburg, , Germany
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, , Germany
Universitaetsklinikum Dresden
Dresden, , Germany
Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Jena
Jena, , Germany
Universitaetsklinikum Schleswig-Holstein - Kiel
Kiel, , Germany
Klinikum der LMU Muenchen
München, , Germany
Evangelismos Hospital
Athens, , Greece
Laiko General Hospital of Athens
Athens, , Greece
Attiko General University Hospital
Athens, , Greece
University Hospital of Heraklion
Heraklion, , Greece
University Hospital of Ioannina
Ioannina, , Greece
University Hospital of Larissa
Larissa, , Greece
University Hospital of Patras
Pátrai, , Greece
General Hospital of Thessaloniki Georgios Papanikolaou
Thessaloniki, , Greece
Queen Mary Hospital, The University of Hong Kong
Hong Kong, , Hong Kong
Princess Margaret Hospital
Kowloon, , Hong Kong
Tuen Mun Hospital
New Territories, , Hong Kong
Semmelweis Egyetem
Budapest, , Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet
Eger, , Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz
Nyíregyháza, , Hungary
Rambam Medical Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari, , Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
Bergamo, , Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
Bologna, , Italy
Ospedale Policlinico San Martino IRCCS
Genova, , Italy
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II
Lecce, , Italy
Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo
Mestre (VE), , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
Napoli, , Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, , Italy
Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito
Pescara, , Italy
Azienda Ospedaliera Policlinico Umberto I
Roma, , Italy
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino
Torino, , Italy
Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma
Verona, , Italy
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Akita University Hospital
Akita, Akita, Japan
Tesshokai Kameda General Hospital
Kamogawa-shi, Chiba, Japan
University of Fukui Hospital
Yoshida-gun, Fukui, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospital
Kurume-shi, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Gunma Saiseikai Maebashi Hospital
Maebashi, Gunma, Japan
Sapporo Hokuyu Hospital
Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Tokai University Hospital
Isehara-shi, Kanagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Kyoto University Hospital
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
National Hospital Organization Okayama Medical Center
Okayama, Okayama-ken, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, Japan
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
Yamagata University Hospital
Yamagata, Yamagata, Japan
Boca Clinical Trials Mexico SC
Mexico City, Mexico City, Mexico
Centro Oncologico Internacional
Mexico City, Mexico City, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Hematologica Alta Especialidad
Huixquilucan, , Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, , Mexico
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Unidade Local de Saude de Coimbra, EPE
Coimbra, , Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE
Lisbon, , Portugal
Unidade Local de Saude de Sao Jose, EPE - Hospital de Santo Antonio dos Capuchos
Lisbon, , Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria
Lisbon, , Portugal
Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
Porto, , Portugal
Institutul Clinic Fundeni
Bucharest, , Romania
Institutul Oncologic Prof Dr Ion Chiricuta
Cluj-Napoca, , Romania
Institutul Regional de Oncologie Iasi
Iași, , Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, , Romania
Narodny onkologicky ustav
Bratislava, , Slovakia
Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda
Bratislava, , Slovakia
Dong-A University Hospital
Busan, , South Korea
Pusan National University Hospital
Busan, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, , South Korea
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain
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
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
L'Hospitalet de Llobregat, Catalonia, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Inselspital Bern
Bern, , Switzerland
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan District, , Taiwan
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, , Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Memorial Antalya Hastanesi
Antalya, , Turkey (Türkiye)
Bagcilar Medipol Mega Universite Hastanesi
Istanbul, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi
Izmir, , Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, , Turkey (Türkiye)
University College London
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-503640-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20190360
Identifier Type: -
Identifier Source: org_study_id