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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 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. The trial reports 20 study locations across 11 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04994717
The ClinicalTrials.gov registry entry for NCT04994717 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 304 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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