Terminated/Withdrawn
Sponsor ID
20190014

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

Sponsor ID
20190014
Clinicaltrials.gov ID
NCT04506086
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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).

Additional Study Details

Phase
Phase 4
Product
blinatumomab
Type
Interventional
Masking
None (Open Label)
Enrollment
10
Additional Study Details

Protocol Summary

Primary Outcome Measures

Cycle 1: Incidence of grade 3 and/or 4 adverse events of special interest

Timeframe: Day 1 to 3 of Cycle 1 (each cycle is 6 weeks)

Cycle 2: Incidence of grade 3 and/or 4 adverse events of special interest

Timeframe: Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)

Cycle 1: Incidence of any adverse events requiring hospitalization

Timeframe: Day 1 to 3 of Cycle 1 (each cycle is 6 weeks)

Cycle 2: Incidence of any adverse events requiring hospitalization

Timeframe: Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)

Secondary Outcome Measures

Time (in minutes) from first onset of fever, hypotension, hypoxia, other grade 3 or 4 vital sign including seizure or neurological change (grade 3-limiting self-care activities of daily living to therapeutic intervention

Timeframe: Day 1 to 3 of Cycle 1, and Day 1 to 2 of Cycle 2 (each cycle is 6 weeks)

Incidence of treatment emergent Adverse events

Timeframe: Up to 6 months

Incidence of Adverse events of Special interest

Timeframe: Up to 6 Months

Severity of treatment emergent adverse events

Timeframe: Up to 6 months

Severity of adverse events of special interest

Timeframe: Up to 6 months

Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30

Timeframe: Prior to treatment on Day 1 of Cycle 1 and 2 (each cycle is 6 weeks)

Incidence of treatment emergent adverse events that resulted in hospitalizations

Timeframe: Up to 6 months

Incidence of treatment emergent adverse events that resulted in surgeries

Timeframe: Up to 6 months

Incidence of treatment emergent adverse events that resulted in the use of concomitant medications

Timeframe: Up to 6 months

Incidence of treatment emergent adverse events that resulted in the use of device/procedure intervention.

Timeframe: Up to 6 months

Locations

Location
Status
Contact Us
Location
Saint Francis Hospital, Inc
Greenville, SC, United States, 29607
Status
Recruiting
Location
Wake Forest University Health Sciences
Winston-Salem, NC, United States, 27157
Status
Recruiting
Location
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando
Orlando, FL, United States, 32804
Status
Completed
Location
University of California Irvine
Orange, CA, United States, 92868-3201
Status
Recruiting
Location
Advocate Lutheran General Hospital
Park Ridge, IL, United States, 60068
Status
Completed
Location
Mount Sinai Hospital
New York, NY, United States, 10029
Status
Completed
Showing {first} - {last} of {total} Results