Feasibility Study to Evaluate Outpatient Blinatumomab in Subjects With Minimal Residual Disease (MRD) of B-precursor Acute Lymphoblastic Leukemia (ALL)
Categories (click each to see list of all clinical trials associated with that category): Leukemia/MDS/MPD (ONC)
Current Status: Open
Phase: IV (Cancer Control)
Principal Investigator: Gundabolu, Krishna
Contact Information:
Penny Hardiman, RN
402-559-4135
penny.hardiman@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04506086?term=NCT04506086&rank=1
Summary
Primary
To determine the safety of outpatient blinatumomab administration, during
the MDMP (defined as the first 3 days of cycle 1 and first 2 days of cycle 2 of
outpatient blinatumomab infusion)
Secondary
To determine the time from first detection of grade 3 or 4 vital sign, or significant clinical change to therapeutic intervention (any measurable action taken by or
performed on the subject due to onset of the clinical parameters described above) during the MDMP
Evaluate the safety and tolerability of blinatumomab administered exclusively as an outpatient
Evaluate the impact of complete outpatient blinatumomab treatment on patient-reported outcome (PRO), global health status (GHS), and quality of life (QoL).
Estimate healthcare resource utilization associated with treatment-related AEs