NCT04506086

Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)

A Phase 4, Multi-center Open-label Feasibility Study to Evaluate Outpatient Blinatumomab Administration in Adult Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL) in Complete Hematologic Remission

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The study aims to determine the safety and feasibility of complete outpatient blinatumomab administration for subjects with minimal/measurable residual disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL).

Conditions

• B-precursor Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Blinatumomab	Participants will receive blinatumomab continuous IV infusion for a maximum of 4 cycles. Each cycle is 6 weeks in duration consisting of 4 weeks of treatment and 2 weeks of rest.
DEVICE	Current Wearable Heatlth Monitoring System (CWHMS)	The study will use the CWHMS device to monitor participants' vital signs while they are at home.

Timeline

• Start date: 2021-08-26
• Primary completion: 2024-07-04
• Completion: 2024-09-16
• First posted: 2020-08-10
• Last updated: 2025-05-18
• Results posted: 2025-05-18

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study