Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia (PC002)

Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma; Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Diagnostic test: PointCheck

• Study Type: Observational
• Enrollment (Estimated): 210

Contacts and Locations

• Study Contact: Name: Alvaro Sanchez-Ferro, MD, PhD; Phone Number: +1 617 419 0974; Email: alvaro@leuko.io

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a multi-site (4 US sites) observational open-label diagnostic study of a non-significant risk medical device, PointCheckTM. Participants (N=210) with specific malignancies who are scheduled to receive antineoplastic therapy will be evaluated during their routine management before the planned cytotoxic drug administration at two-time points (baseline and nadir evaluation). This will be an event-driven study with a total number of 70 positive cases (ANC < 500 cells/mm3) and 140 negative cases (ANC >= 500 cells/mm3) has been considered sufficient to provide accurate estimates of Sensitivity and Specificity. They will have concurrent evaluations with PointCheckTM and a blood differential cell count in addition to the standard clinical visits. A subset (N=45) of patients will be evaluated for between-instrument reproducibility. Finally, a sub-study (N=30) will confirm the usability of PointCheckTM in the home setting.

Description

Inclusion Criteria:

• Able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
• Male or Female aged 10 years or above.
• Diagnosed with either Diffuse Large B Cell Lymphoma or Multiple Myeloma.
• Scheduled treatment with any antineoplastic therapy with an associated high/intermediate risk of neutropenia according to NCCN guidelines.
• Able (in the investigator's opinion) and willing to comply with all study requirements.

Exclusion Criteria:

• Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator.
• Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold.
• Participants with circulating tumour cells in previous or current lab determinations.
• Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
• Unstable participants or participants with hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PointCheck Accuracy	The main primary endpoints for this study will be the sensitivity and specificity of PointCheckTM to detect grade IV neutropenia ac cording to the CTCAE V5 definition of severe neutropenia in a standard blood analysis.	Two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PointCheck Precision	Repeatability and reproducibility will be assessed using the % positive/negative results of the test's classification compared to the gold standard after multiple measurements in different contexts.	Two-weeks
PointCheck Usability	Mean System Usability Score	Two-weeks
PointCheck Errors	Device related errors (number/type)	Two-weeks
PointCheck Safety	total number (and %) of AEs and SAEs related to the device use.	Two-weeks

Collaborators and Investigators

• Sponsor: Leuko Labs, Inc.
• Investigators: Principal Investigator: Carlos Castro Gonzalez, PhD, Leuko Labs

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): April 28, 2026

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Agranulocytosis; Leukopenia; Leukocyte Disorders; Lymphoma; Lymphoma, B-Cell; Cytopenia; Lymphoma, Large B-Cell, Diffuse; Multiple Myeloma; Neutropenia
• Other Study ID Numbers: PC002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No