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NCT04521231 · ClinicalTrials.gov registry record · Phase 1
A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
A Phase 1 study of B Cell Precursor Acute Lymphoblastic Leukemia, sponsored by Amgen.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 281
- Enrollment target
- 20
- Study locations
NCT04521231 is a Phase 1 study of B Cell Precursor Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Amgen. The registered enrollment target is 281 participants. The trial reports 20 study locations across 16 states.
The verdict
NCT04521231, a Phase 1 study of B Cell Precursor Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Amgen.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 281 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 281 participants |
| Start Date | 2021-01-04 |
| Est. Completion | 2029-05-25 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. 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 558 total studies on file at ClinicalTrials.gov.
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.
NCT04521231 reports 20 study locations spanning 16 distinct geographic areas - top geographies include New York, Washington, Other.
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.
What interventions are being tested in trial NCT04521231?
The interventions under investigation include: Blinatumomab (DRUG).
Who is sponsoring clinical trial NCT04521231?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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