NCT04521231

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 281 (estimated)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

• B Cell Precursor Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Blinatumomab	Blinatumomab will be administered as a subcutaneous (SC) injection.

Timeline

• Start date: 2021-01-04
• Primary completion: 2027-11-24
• Completion: 2029-05-25
• First posted: 2020-08-20
• Last updated: 2026-04-16

Locations

102 sites across 19 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Romania, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study