A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL
Public ClinicalTrials.gov record NCT04521231. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Adults and Adolescents With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (R/R B-ALL) and Minimal Residual Disease Positive (MRD+) B-ALL
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04521231
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 181 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 4, 2021 (Actual)
- Primary completion
- Nov 24, 2027 (Estimated)
- Completion
- May 25, 2029 (Estimated)
- Last update posted
- May 28, 2026
2021 – 2029
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco Fresno at Community Cancer Institute | Clovis | California | 93611 | — |
| City of Hope National Medical Center | Duarte | California | 91010 | — |
| University of Illinois Chicago | Chicago | Illinois | 60612 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| C.S. Mott Children's Hospital - University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | — |
| New York University Grossman School of Medicine and New York University Langone Hospitals | New York | New York | 10016 | — |
| Albert Einstein College of Medicine - Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Childrens Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| St Jude Childrens Research Hospital | Memphis | Tennessee | 38105 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109-1023 | — |
| The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 96 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04521231, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 28, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04521231 live on ClinicalTrials.gov.