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NCT06323447 · ClinicalTrials.gov record · last posted 2026-07-31

Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia

Name: Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia — clinical trial record (NCT06323447)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: PC002

StatusActive, Not Recruiting

PhaseNot specified

SponsorLeuko Labs, Inc.

Started2025-12-15

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.

Protocol amendment history 4 changes detected by DataLookout

2026-08-01

Trial status changed: Not Yet Recruiting → Active, Not Recruiting

2026-08-01

Trial sites expanded: 0 → 6 locations

2026-08-01

Primary completion pushed: 2026-03-30 → 2027-06-30

2026-08-01

Completion pushed: 2026-04-28 → 2027-06-30

Trial Details

NCT Number	NCT06323447
Lead Sponsor	Leuko Labs, Inc.
Conditions	Diffuse Large B Cell Lymphoma, Multiple Myeloma
Enrollment	210 participants
Start Date	2025-12-15
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-31