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NCT04994717 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL), sponsored by Amgen.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 304
- Enrollment target
- 20
- Study locations
NCT04994717: Recruiting Phase 3 study of Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL), sponsored by Amgen.
NCT04994717 is a Phase 3 study of Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL) that is actively recruiting participants, run by Amgen. The registered enrollment target is 304 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04994717, a Phase 3 study of Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL), is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 304 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Number and percentage of participants who experience one or more TEAE, serious TEAE, treatment-related adverse events, and adverse events of interest.
Conditions Studied
Interventions
- DRUG Blinatumomab
- DRUG Low-intensity chemotherapy regimen
- DRUG SOC chemotherapy regimen
Study Locations (20)
New South Wales
- Royal Prince Alfred Hospital - Camperdown
- Liverpool Hospital - Liverpool
- Royal North Shore Hospital - St Leonards
- Westmead Hospital - Westmead
Victoria
- Monash Medical Centre - Clayton
- Austin Health, Austin Hospital - Heidelberg
- Peter MacCallum Cancer Centre - Melbourne
- The Alfred Hospital - Melbourne
California
- City of Hope National Medical Center - Duarte
- University of California Irvine - Orange
- University of California San Francisco - San Francisco
Queensland
- Royal Brisbane and Womens Hospital - Herston
- Princess Alexandra Hospital - Woolloongabba
Florida
- Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando - Orlando
Ohio
- Cleveland Clinic Foundation - Cleveland
South Carolina
- Saint Francis Hospital, Inc - Greenville
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 304 participants |
| Start Date | 2021-11-02 |
| Est. Completion | 2031-07-01 |
| Phase | Phase 3 |
What NCT04994717 shows while recruiting
NCT04994717 is an interventional study that assigns participants to a tested intervention. The registered 304 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL) appearing as the primary indexed condition, and to 3 interventions - of which Blinatumomab is the first listed.
NCT04994717 names 20 study sites across 11 states, led by New South Wales, Victoria, California.
Frequently Asked Questions
What is clinical trial NCT04994717 about?
NCT04994717 is a clinical study titled "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". 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-...
What is the current status of trial NCT04994717?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 304 participants. The study started on 2021-11-02. Estimated completion is 2031-07-01.
What conditions does trial NCT04994717 study?
This clinical trial studies the following conditions: Newly Diagnosed Philadelphia (Ph)-Negative B-cell Precursor Acute Lymphoblastic Leukemia (ALL).
What interventions are being tested in trial NCT04994717?
The interventions under investigation include: Blinatumomab (DRUG), Low-intensity chemotherapy regimen (DRUG), SOC chemotherapy regimen (DRUG).
Who is sponsoring clinical trial NCT04994717?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04994717 being conducted?
This trial has 20 study locations across California, Florida, Ohio, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04994717's enrollment target sits among peer trials
304 1118th of 2000 higher than 882 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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