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Clinical Trials in the UK / NCT04994717
Active, not recruiting Phase 3

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

NCT04994717 · tracked via the Priya Life Science UK tracker
Sponsor
Amgen
Phase
Phase 3
Started
2021-11-02
Last updated
2026-06-30

Condition(s) studied

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

Investigational drug(s) / intervention(s)

BlinatumomabLow-intensity chemotherapy regimenSOC chemotherapy regimen

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.

Study 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 chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.

Eligibility

Sex
ALL
Min age
40 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: \- 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 * 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: * 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 * 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.

Primary outcome measure(s)

Trial sites (192)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California
University of California Irvine Orange California
University of California San Francisco San Francisco California
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando Orlando Florida
Cleveland Clinic Foundation Cleveland Ohio
Saint Francis Hospital, Inc Greenville South Carolina
University of Texas MD Anderson Cancer Center Houston Texas
Canberra Hospital Garran Australian Capital Territory
Royal Prince Alfred Hospital Camperdown New South Wales
Liverpool Hospital Liverpool New South Wales
Royal North Shore Hospital St Leonards New South Wales
Westmead Hospital Westmead New South Wales
Royal Brisbane and Womens Hospital Herston Queensland
Princess Alexandra Hospital Woolloongabba Queensland
Royal Adelaide Hospital Adelaide South Australia
Monash Medical Centre Clayton Victoria
Austin Health, Austin Hospital Heidelberg Victoria
Peter MacCallum Cancer Centre Melbourne Victoria
The Alfred Hospital Melbourne Victoria
Fiona Stanley Hospital Murdoch Western 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
Hospital das Clinicas da Universidade Federal de Goias Goiânia Goiás
Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul
Fundacao Amaral Carvalho Jaú São Paulo
Hosp Clin Fac Med Ribeirao Preto Usp Ribeirão Preto São Paulo
Hospital de Base de Sao Jose do Rio Preto São Jose Do Rio Preto São Paulo
Hemorio Rio de Janeiro Brazil

+ 152 more sites — see the full list on the official registry below.

More Amgen trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04994717 on ClinicalTrials.gov ↗ ← All trials in the UK