Lymphocyte Depletion and Change in Lymphocyte Functionality
Active, enrolledNAResults postedLast updated 10 December 2024
What this trial tests
NA trial testing SBRT with additional treatment planning dose optimization in Lymphocyte Depletion in 55 participants. Participants enrolled and being followed up; not accepting new ones.
Timeline
12 February 2020
Primary endpoint 15 May 2023
1 June 2025
Quick facts
Lead sponsor
University of Virginia
Phase
NA
Status
Active, enrolled
Study type
INTERVENTIONAL
Allocation
randomized
Design
parallel
Masking
single
Primary purpose
prevention
Enrollment
55
Start date
12 February 2020
Primary completion
15 May 2023
Estimated completion
1 June 2025
Sites
1 location across United States
Drugs / interventions tested
SBRT with additional treatment planning dose optimization
18 and older, any sex, with Lymphocyte Depletion. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Impact of Lymphocyte-Sparing SBRT Planning Objectives on Post-SBRT Lymphocyte CountPrimary· Baseline to End of SBRT (up to 12 days), 4 weeks after SBRT (up to 1.5 months) and 6 months after SBRT (up to 10 months)
Mean percentage difference of measured absolute lymphocyte counts between the baseline and at each time points for the two separate arms
Determine if an Algorithm Can Predict the Magnitude of Post SBRT Lymphocyte Depletion Prospectively for Participants With NSCLCPrimary· Baseline to End of SBRT (up to 12 days), 4 weeks after SBRT (up to 1.5 months) and 6 months after SBRT (up to 10 months)
Median of the difference between predicted value and observed measurement of lymphocyte absolute counts.
Time frame: From the time informed consent is obtained until 6 months after completion of SBRT (up to 11months).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Lymphocytes are a type of white blood cell (WBC) responsible for adaptive immunity. Thoracic tumors are adjacent to many blood/immune rich organs including the great vessels, heart, thoracic-spine, and lymph-node-stations. During radiation treatment the impact to lymphocytes can be significant. This may cause a decrease in the amount of lymphocytes. A researcher at UVA has created a system to predict and reduce the immune cell reduction following lung SBRT treatments beyond standard of care. The predicted decrease in lymphocytes will be compared to the actual decrease in lymphocytes found in peripheral blood.
Researchers have found a way to give radiation that they think will result in a smaller decrease in lymphocytes after radiation. There will be two groups in this study, about half of the participants will have their radiation designed to decrease radiation to organs with a lot of blood and the other half will receive standard radiation therapy.
Participants are being asked to take part in this study because the participants have been diagnosed with NSCLC and will be receiving a type of radiation therapy called stereotactic body radiation therapy (SBRT) where high doses of radiation will be delivered to the tumor, while minimizing damage to healthy surrounding tissues.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05880355 — Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI
· EARLY_PHASE1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Virginia
Last refreshed: 10 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04273893.