Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING 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

NCT04994717 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 304 participants
Start Date 2021-11-02
Est. Completion 2031-07-01
Phase Phase 3

Sponsor

Amgen

266 total trials

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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04994717 reports 20 study locations spanning 11 distinct geographic areas — top geographies include New South Wales, Victoria, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04994717?

The interventions under investigation include: Blinatumomab (DRUG), Low-intensity chemotherapy regimen (DRUG), SOC chemotherapy regimen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04994717?

This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial