Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
City of Hope Medical Center
With
PRIMARY OBJECTIVE: I. Evaluate the feasibility of COLT with TIL therapy. SECONDARY OBJECTIVES: I. Evaluate the safety of COLT with TIL therapy. II. Evaluate the acceptability of COLT intervention to patients. III. Evaluate the effect of COLT on patient-reported quality of life metrics. EXPLORATORY OBJECTIVES: I. Evaluate changes that occur in patient circadian clocks with COLT during TIL therapy using actigraphy and circadian clock gene analysis. II. Evaluate the alterations and time course that occur in tumor immune cell subsets and phenotype with COLT during TIL therapy. III. Evaluate the toxicities related to TIL therapy (i.e., cytopenia, interleukin 2 \[IL-2\] toxicity) that occur with COLT during TIL therapy. OUTLINE: Starting on day -14, patients receive access to the Circadian OS application and within the first hour of waking up undergo light therapy sessions over 1 hour daily between 8:00 and 10:00 am for up to 28 days after TIL in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care TIL infusion on day 0. Patients may optionally continue COLT for up to 90 days post TIL infusion. Patients also wear wrist actigraphy continuously to monitor sleep-wake cycles, light exposure, and circadian rhythms during TIL therapy. Additionally, patients undergo blood sample collection throughout the study. After completion of study intervention, patients are followed up at 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
