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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Safety run-in: Number of Participants who Experience Treatment-emergent Adverse Events (TEAEs) — Up to approximately 5 years
Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest. - Phase 3: Event-free Survival (EFS) — Up to approximately 5 years
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. - Phase 3: Overall Survival (OS) — Up to approximately 5 years
OS is defined as time from randomization (enrollment) until death due to any cause.
Trial sites (192)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 South Korea
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 South Korea