AzTrials
AzTrials

Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL)Phase 3NCT04994717

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

A Phase 3 study testing Blinatumomab, Low-intensity chemotherapy regimen and SOC chemotherapy regimen in people with Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL), run by Amgen at 192 sites in 32 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 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… Read more about this study

Who is it for?
Ages 40 to 100 years
What is being tested?
Blinatumomab, Low-intensity chemotherapy regimen and SOC chemotherapy regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
192 sitesin 32 countries
Study dates
2 Nov 2021to 30 Jun 2031
Phase
Phase 3
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 40 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 55 years at the time of informed consent. OR
  • 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
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  • 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.

Who cannot join

  • Active central nervous system (CNS) leukemia (i.e., CNS 3 leukemia, confirmed by lumbar puncture) not resolved with IT chemotherapy during screening.
  • 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 Note: History of other malignancy (eg, multiple myeloma) treated with immunomodulatory drugs (eg, lenalidomide, thalidomide) in the past 3 years is an exclusion.
  • 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
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  • 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.

Trial locations and contacts

192 sites in 32 countries.

192 sites in 32 countries

Japan23 sites

  • Akita University Hospital

    Akita, Akita, 010-8543

  • Tokyo Metropolitan Komagome Hospital

    Bunkyo-ku, Tokyo, 113-8677

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Fukushima Medical University Hospital

    Fukushima, Fukushima, 960-1295

  • Tokai University Hospital

    Isehara-shi, Kanagawa, 259-1193

  • Nihon University Itabashi Hospital

    Itabashi-ku, Tokyo, 173-8610

  • Tesshokai Kameda General Hospital

    Kamogawa-shi, Chiba, 296-8602

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Gunma Saiseikai Maebashi Hospital

    Maebashi, Gunma, 371-0821

  • Nagasaki University Hospital

    Nagasaki, Nagasaki, 852-8501

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

  • Kindai University Hospital

    Sakai-shi, Osaka, 590-0197

  • Sapporo Hokuyu Hospital

    Sapporo, Hokkaido, 003-0006

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Jichi Medical University Hospital

    Shimotsuke-shi, Tochigi, 329-0498

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024

  • University of Fukui Hospital

    Yoshida-gun, Fukui, 910-1193

Other trials in Japan

France14 sites

  • Hopital Henri Mondor

    Créteil, 94010

  • Centre Hospitalier Universitaire de Dijon - Hopital du Bocage

    Dijon, 21000

  • Centre Hospitalier de Versailles - Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez

    Lille, 59000

  • Institut Paoli Calmettes

    Marseille, 13009

  • Centre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu

    Nantes, 44000

  • Centre Hospitalier Universitaire Archet 2

    Nice, 06202

  • Hopital Saint Louis

    Paris, 75010

  • Hopital Saint Antoine

    Paris, 75012

  • Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque

    Pessac, 33604

  • Hopital Lyon Sud

    Pierre-Bénite, 69645

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35000

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059

  • Centre Hospitalier Universitaire de Nancy - Hopital de Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Australia13 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Austin Health, Austin Hospital

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Womens Hospital

    Herston, Queensland, 4029

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Italy13 sites

  • Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari

    Bari, 70124

  • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii

    Bergamo, 24127

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola

    Bologna, 40138

  • IRCCS Azienda Ospedaliera Metropolitana

    Genova, 16132

  • Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

    Lecce, 73100

  • Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo

    Mestre (VE), 30174

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli

    Naples, 80131

  • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

    Perugia, 06156

  • Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito

    Pescara, 65124

  • Azienda Ospedaliera Policlinico Umberto I

    Roma, 00161

  • Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126

  • Azienda Ospedaliera Universitaria Integrata di Verona Ospedale G B Rossi Borgo Roma

    Verona, 37134

Other trials in Italy

Belgium9 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, 8000

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Jessa Ziekenhuis - Campus Virga Jesse

    Hasselt, 3500

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

  • AZ Delta Campus Rumbeke

    Roeselare, 8800

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

    Yvoir, 5530

Other trials in Belgium

Spain9 sites

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

    Badalona, Catalonia, 08916

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalonia, 08908

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • 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 Universitari i Politecnic La Fe

    Valencia, Valencia, 46026

Other trials in Spain

Brazil8 sites

  • Igesd Instituto de Gestao Estrategica da Saude do Distrito Federal

    Brasília, Federal District, 70335-902

  • Hospital das Clinicas da Universidade Federal de Goias

    Goiânia, Goiás, 74605-020

  • Fundacao Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Hosp Clin Fac Med Ribeirao Preto Usp

    Ribeirão Preto, São Paulo, 14048-900

  • Hemorio

    Rio de Janeiro, 22640-000

  • Hospital de Base de Sao Jose do Rio Preto

    São Jose Do Rio Preto, São Paulo, 15090-000

  • Instituto Cancer Sao Paulo Icesp

    São Paulo, 01246-000

Other trials in Brazil

Canada8 sites

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Queen Elizabeth II, Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V8

  • Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • CEMTL Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

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

    Vancouver, British Columbia, V5Z 1M9

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3H 0V9

Other trials in Canada

Germany8 sites

  • Universitaetsklinikum Augsburg

    Augsburg, 86156

  • Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

    Berlin, 12203

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Jena

    Jena, 07747

  • Universitaetsklinikum Schleswig-Holstein - Kiel

    Kiel, 24105

  • Klinikum der LMU Muenchen

    München, 81377

Other trials in Germany

Greece8 sites

  • Evangelismos Hospital

    Athens, 10676

  • Laiko General Hospital of Athens

    Athens, 11527

  • Attiko General University Hospital

    Athens, 12462

  • University Hospital of Heraklion

    Heraklion, 71500

  • University Hospital of Ioannina

    Ioannina, 45500

  • University Hospital of Larissa

    Larissa, 41110

  • University Hospital of Patras

    Pátrai, 26504

  • General Hospital of Thessaloniki Georgios Papanikolaou

    Thessaloniki, 57010

Other trials in Greece

United States7 sites

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Saint Francis Hospital, Inc

    Greenville, South Carolina, 29607

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California Irvine

    Orange, California, 92868-3201

  • Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando

    Orlando, Florida, 32804

  • University of California San Francisco

    San Francisco, California, 94143

Other trials in United States

South Korea7 sites

  • Dong-A University Hospital

    Busan, 49201

  • Pusan National University Hospital

    Busan, 49241

  • Chungnam National University Hospital

    Daejeon, 35015

  • Chonnam National University Hwasun Hospital

    Hwasun, 58128

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

Other trials in South Korea

Romania6 sites

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098

  • Institutul Oncologic Prof Dr Ion Chiricuta

    Cluj-Napoca, 400015

  • Spitalul Clinic Municipal Filantropia Craiova

    Craiova, 200143

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550245

Other trials in Romania

Turkey (Türkiye)6 sites

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Memorial Antalya Hastanesi

    Antalya, 07025

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214

  • Dokuz Eylul Universitesi Tip Fakultesi Hastanesi

    Izmir, 35340

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55139

Other trials in Turkey (Türkiye)

Hungary5 sites

  • Semmelweis Egyetem

    Budapest, 1088

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet

    Eger, 3300

  • Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz

    Nyíregyháza, 4400

Other trials in Hungary

Mexico5 sites

  • Hematologica Alta Especialidad

    Huixquilucan, 52787

  • Boca Clinical Trials Mexico SC

    Mexico City, Mexico City, 01120

  • Centro Oncologico Internacional

    Mexico City, Mexico City, 01330

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

Other trials in Mexico

Portugal5 sites

  • Unidade Local de Saude de Coimbra, EPE

    Coimbra, 3004-561

  • Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

    Lisbon, 1099-023

  • Unidade Local de Saude de Sao Jose, EPE - Hospital de Santo Antonio dos Capuchos

    Lisbon, 1169-050

  • Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria

    Lisbon, 1649-035

  • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE

    Porto, 4200-072

Other trials in Portugal

Taiwan5 sites

  • China Medical University Hospital

    Taichung, 40458

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital

    Taipei, 10002

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305

Other trials in Taiwan

Austria4 sites

  • Medizinische Universitaet Graz

    Graz, 8036

  • Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • Ordensklinikum Linz Elisabethinen

    Linz, 4020

  • Hanusch Krankenhaus

    Vienna, 1140

Other trials in Austria

Denmark4 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Aarhus Universitetshospital

    Aarhus N, 8200

  • Rigshospitalet

    København Ø, 2100

  • Odense Universitetshospital

    Odense, 5000

Other trials in Denmark

Chile3 sites

  • Fundacion Arturo Lopez Perez

    Santiago, 7500921

  • Inmunocel

    Santiago, 7580206

  • Clinica Alemana de Santiago

    Santiago, 7650729

Other trials in Chile

Czechia3 sites

  • Fakultni nemocnice Brno

    Brno, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Ustav hematologie a krevni transfuze

    Prague, 128 20

Other trials in Czechia

Hong Kong3 sites

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

  • Princess Margaret Hospital

    Kowloon

  • Tuen Mun Hospital

    New Territories

Other trials in Hong Kong

Israel3 sites

  • Rambam Medical Center

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4941492

Other trials in Israel

Bulgaria2 sites

  • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD

    Plovdiv, 40002

  • Specialized Hospital for Active Treatment of Hematology Diseases EAD

    Sofia, 1797

Other trials in Bulgaria

Estonia2 sites

  • North Estonia Medical Centre

    Tallinn, 13 419

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Finland2 sites

  • Helsinki University Hospital

    Helsinki, 00029

  • Turku University Hospital

    Turku, 20521

Other trials in Finland

Slovakia2 sites

  • Narodny onkologicky ustav

    Bratislava, 833 10

  • Univerzitna nemocnica Bratislava, Nemocnica sv Cyrila a Metoda

    Bratislava, 851 07

Other trials in Slovakia

United Kingdom2 sites

  • University College London

    London, NW1 2PG

  • Kings College Hospital

    London, SE5 9RS

Other trials in United Kingdom

Netherlands1 site

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

Other trials in Netherlands

Sweden1 site

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

Other trials in Sweden

Switzerland1 site

  • Inselspital Bern

    Bern, 3010

Other trials in Switzerland

About this study

Official title: Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)

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.

Being tested
Blinatumomab, Low-intensity chemotherapy regimen, SOC chemotherapy regimen
Keywords
Newly Diagnosed Philadelphia (Ph)-negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL), Blinatumomab, Low-intensity Chemotherapy, GMALL HyperCVAD

What participants receive

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

  • BlinatumomabDrug

    Also called Blincyto®

    Continuous intravenous (cIV) infusion

  • Low-intensity chemotherapy regimenDrug

    Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.

  • SOC chemotherapy regimenDrug

    Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.

Study groups in NCT04994717
Study groupRoleWhat they receive
Safety Run-in: Blinatumomab alternating with low-intensity chemotherapyExperimentalThe 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.
Receives: Drug: Blinatumomab; Drug: Low-intensity chemotherapy regimen
Phase 3: Blinatumomab alternating with low-intensity chemotherapyExperimentalParticipants will receive blinatumomab alternating with low-intensity chemotherapy.
Receives: Drug: Blinatumomab; Drug: Low-intensity chemotherapy regimen
Phase 3: Standard of care (SOC) chemotherapyActive comparatorParticipants will receive 1 of 2 SOC chemotherapy regimens (GMALL or HyperCVAD) per investigator's choice.
Receives: Drug: SOC chemotherapy regimen

What is being measured

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

  1. Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)

    Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.

    Measured: Up to approximately 5 years

  2. Phase 3: Event-free Survival (EFS)

    Time from randomization (enrollment) until treatment failure, relapse or death from any cause, whichever is earlier.

    Treatment failure is defined as not achieving a hematological complete CR with MRD response <10-4 by the end of the initial disease assessment period.

    Relapse is defined as hematologic relapse, extramedullary relapse, and/or molecular relapse (MRD positivity >= 10^-3), whichever occurs earlier, in participants with prior achievement of hematologic CR with MRD response <10^-4.

    Participants without an event will be censored at their last evaluable disease assessment date.

    Measured: Up to approximately 5 years

  3. Phase 3: Overall Survival (OS)

    OS is defined as time from randomization (enrollment) until death due to any cause.

    Measured: Up to approximately 5 years

Secondary outcomes (35)

  1. Safety run-in: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period

    Measured: Baseline to Week 14

  2. Safety run-in: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period

    MRD response is defined as the percentage of participants who achieve a response of < 10^-4 measured by polymerase chain reaction (PCR).

    Measured: Baseline to Week 14

  3. Safety run-in: Relapse-free Survival (RFS)

    RFS: In participants who achieve CR, the time from first achievement of this response until date of the first relapse including hematologic relapse, extramedullary relapse, or death due to any cause, whichever occurs first.

    Measured: Up to approximately 5 years

  4. Safety run-in: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)

    MRD RFS: In participants who achieve CR with MRD response, the time from first achievement of this response until date of of the first relapse including molecular relapse, hematological relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs first. (Molecular relapse will be defined 2 ways: MRD>= 10^-3 and MRD>=10^-4. Participants without an event will be censored at their last evaluable disease assessment date.

    Measured: Up to approximately 5 years

  5. Safety run-in: Steady State Concentration (Css) of Blinatumomab

    Measured: Up to approximately 34 weeks

  6. Safety run-in: Clearance (CL) of Blinatumomab

    Measured: Up to approximately 34 weeks

  7. Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Fatigue Score

    Fatigue score will be measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue - Short Form 7a.

    Measured: Baseline to Week 14

  8. Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Pain Score

    Pain score will be measured by Brief Pain Inventory - Short Form (BPI-SF); Item 3: pain at its worst in the last 24 hours.

    Measured: Baseline to Week 14

  9. Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Global Health Status

    Global health status will be measured by the Quality of Life Questionnaire (QLQ)-C30 global health status quality of life scale.

    Measured: Baseline to Week 14

  10. Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Physical Function

    Physical function will be measured by the QLQ-C30 functional scale.

    Measured: Baseline to Week 14

  11. Phase 3: Change from Baseline to End of Initial Disease Assessment Period in Nausea and Vomiting

    Nausea and vomiting will be measured by the QLQ-C30 symptom scale.

    Measured: Baseline to Week 14

  12. Phase 3: Complete Remission (CR) Rate by the End of Initial Disease Assessment Period

    Measured: Baseline to Week 14

  13. Phase 3: Minimal Residual Disease (MRD) Response by the End of Initial Disease Assessment Period

    MRD response is defined as the percentage of participants who achieve a response of < 10^4 measured by polymerase chain reaction (PCR).

    Measured: Baseline to Week 14

  14. Phase 3: Relapse-free Survival (RFS)

    RFS: In participants who achieve CR, the time from first achievement of this response until the date of the first relapse including hematologic relapse, extra medullary relapse, or death due to any cause, whichever occurs first. Participants without an event will be censored at their last evaluable disease assessment date.

    Measured: Up to approximately 5 years

  15. Phase 3: Minimal Residual Disease (MRD) Relapse Free Survival (RFS)

    In participants who achieve CR with MRD response, the time from first achievement of this response until date of the first relapse including molecular relapse, hematologic relapse, and/or extramedullary relapse, or death due to any cause, whichever occurs first. Molecular relapse will be defined 2 ways: MRD>= 10^-3 and MRD>= 10^-4. Participants without an event will be censored at their last evaluable disease assessment date

    Measured: Up to approximately 5 years

  16. Phase 3: Minimal Residual Disease (MRD) Over Time

    Measured: Up to approximately 5 years

  17. Phase 3: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs)

    Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.

    Measured: Up to approximately 5 years

  18. Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse by Flow Cytometry for Bone Marrow

    Measured: Up to approximately 5 years

  19. Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse Identified by Immunohistochemistry or Flow Cytometry for Cerebrospinal Fluid

    Measured: Up to end of safety follow up (approximately 44 months)

  20. Phase 3: Number of Participants who Experience Cluster of Differentiation (CD) 19 Positive and Negative Relapse for Extramedullary Sites other than Cerebrospinal Fluid

    Measured: Up to end of safety follow up (approximately 44 months)

  21. Phase 3: Rate of Lineage Switch to Acute Myeloid Leukemia (AML)

    Measured: Up to end of safety follow up (approximately 44 months)

  22. Phase 3: Localization of Relapse by Clinical Assessment

    Measured: Up to end of safety follow up (approximately 44 months)

  23. Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR)

    Measured: Up to approximately 5 years

  24. Phase 3: Number of Participants who have Allogeneic Hematopoietic Stem Cell Transplant (alloHSCT) in Participants who Experience Continuous First Complete Remission (CR)

    Measured: Up to approximately 5 years

  25. Phase 3: Mortality Rate in Participants who Experience Complete Remission (CR) after Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)

    Measured: Up to approximately 5 years

  26. Phase 3: Relapse Rate Following Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT)

    Measured: Up to approximately 5 years

  27. Phase 3: Time to Deterioration using the Fatigue Score

    Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.

    Measured: Up to approximately 5 years

  28. Phase 3: Time to Improvements using the Fatigue Score

    Fatigue score will be measured by PROMIS Fatigue-Short Form 7a.

    Measured: Up to approximately 5 years

  29. Phase 3: Time to Deterioration using the Pain Score

    Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.

    Measured: Up to approximately 5 years

  30. Phase 3: Time to Improvements using the Pain Score

    Pain score will be measured by BPI-SF; Item 3: pain at its worst in the last 24 hours.

    Measured: Up to approximately 5 years

  31. Phase 3: Change from Baseline in Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    EORTC QLQ-C30 will include global health status, physical functioning, emotional functioning, cognitive functioning, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QLQ-C30.

    Measured: Baseline to end of study (up to approximately 5 years)

  32. Phase 3: Time to Deterioration for Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QCQ-C30.

    Measured: Up to approximately 5 years

  33. Phase 3: Time to Improvements for Global Health Status, Physical Function, Nausea/Vomiting, and All Other Subscales of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, diarrhea, and financial difficulties will be measured by EORTC QCQ-C30.

    Measured: Up to approximately 5 years

  34. Steady State Concentration of Blinatumomab

    Measured: Up to approximately Day 36

  35. Clearance of Blinatumomab

    Measured: Up to approximately Day 36

Timeline

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

  1. First posted6 Aug 2021
  2. Study start2 Nov 2021
  3. Primary completion7 Sep 2029 (estimated)
  4. Study completion30 Jun 2031 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04994717
Sponsor's protocol ID
20190360
Other IDs
2023-503640-14, 2023
Status last verified
Jun 2026
First submitted
30 Jul 2021
Last updated
30 Jun 2026
Results posted
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Blinatumomab, Low-intensity chemotherapy regimen and SOC chemotherapy regimen in people with Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL), run by Amgen at 192 sites in 32 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 13 inclusion and 18 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in Japan, France, Australia, Italy, Belgium and 27 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) (time frame: Up to approximately 5 years). The study lists 3 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 NCT04994717.

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 30 Jun 2026.

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