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

ClinicalTrials.gov ID: NCT04994717

Public ClinicalTrials.gov record NCT04994717. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 10, 2026, 9:42 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Study identification

NCT ID: NCT04994717
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Amgen; Industry
Enrollment: 304 participants

Conditions and interventions

Conditions

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

Interventions

Blinatumomab Drug
Low-intensity chemotherapy regimen Drug
SOC chemotherapy regimen Drug

Drug

Eligibility (public fields only)

Age range: 40 Years to 100 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 1, 2021
Primary completion: Sep 6, 2029
Completion: Jun 30, 2031
Last update posted: May 7, 2026

2021 – 2031

United States locations

U.S. sites: 7
U.S. states: 5
U.S. cities: 7

Facility	City	State	ZIP	Site status
City of Hope National Medical Center	Duarte	California	91010	Recruiting
University of California Irvine	Orange	California	92868-3201	Recruiting
University of California San Francisco	San Francisco	California	94143	Recruiting
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando	Orlando	Florida	32804	Terminated
Cleveland Clinic Foundation	Cleveland	Ohio	44195	Terminated
Saint Francis Hospital, Inc	Greenville	South Carolina	29607	Completed
University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Completed

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 185 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04994717, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 7, 2026 · Synced May 10, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04994717 live on ClinicalTrials.gov.

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