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RECRUITING Phase 1

A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL

NCT04521231 · View on ClinicalTrials.gov ↗

Study Summary

The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. The Phase II part of the study will evaluate the safety, efficacy, and tolerability of SC blinatumomab for treatment of R/R B-ALL and Minimum Residual Disease Positive (MRD+) B-ALL in participants 12 years old and greater. It will also conduct a clinical pharmacokinetic (PK) evaluation of SC1 and SC2 blinatumomab formulations.

Interventions

  • DRUG Blinatumomab

Study Locations (20)

New York

  • New York University Grossman School of Medicine and New York University Langone Hospitals — New York
  • Albert Einstein College of Medicine - Montefiore Medical Center — The Bronx

Washington

  • Fred Hutchinson Cancer Center — Seattle
  • Fred Hutchinson Cancer Center — Seattle

Other

  • Instituto Alexander Fleming — Buenos Aires
  • Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno — Ciudad Autonoma Buenos Aires

New South Wales

  • Sydney Childrens Hospital — Randwick
  • Westmead Hospital — Westmead

California

  • City of Hope National Medical Center — Duarte

Illinois

  • University of Illinois Chicago — Chicago

Maryland

  • Johns Hopkins University — Baltimore

Michigan

  • C.S. Mott Children's Hospital - University of Michigan — Ann Arbor

Trial Details

FieldValue
Enrollment Target 281 participants
Start Date 2021-01-04
Est. Completion 2029-05-25
Phase Phase 1

Sponsor

Amgen

266 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04521231

The ClinicalTrials.gov registry entry for NCT04521231 describes a study currently listed as recruiting. It is categorized as Phase 1, 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 281 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 B Cell Precursor Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention — 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: NCT04521231 reports 20 study locations spanning 16 distinct geographic areas — top geographies include New York, Washington, Other. 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 NCT04521231 about?

NCT04521231 is a clinical study titled "A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL". The Phase I part of the study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Relapsed or Refractory B cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (R...

What is the current status of trial NCT04521231?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 281 participants. The study started on 2021-01-04. Estimated completion is 2029-05-25.

What conditions does trial NCT04521231 study?

This clinical trial studies the following conditions: B Cell Precursor Acute Lymphoblastic Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04521231?

The interventions under investigation include: Blinatumomab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04521231?

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 NCT04521231 being conducted?

This trial has 20 study locations across California, Illinois, Maryland, Michigan, New York. 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