NCT04994717

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 304 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Blinatumomab	Continuous intravenous (cIV) infusion
DRUG	Low-intensity chemotherapy regimen	Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.
DRUG	SOC chemotherapy regimen	Intravenous (IV), oral (PO), subcutaneous (SC), or intrathecal (IT) administration.

Timeline

• Start date: 2021-11-02
• Primary completion: 2029-09-07
• Completion: 2031-07-01
• First posted: 2021-08-06
• Last updated: 2026-04-16

Locations

192 sites across 32 countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Portugal, Romania, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study