Recruiting

PointCheck

Sponsor:

Leuko Labs, Inc.

Code:

NCT06323447

Conditions

Diffuse Large B Cell Lymphoma

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Interventions

PointCheck

Study Details

Brief summary:

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.

Conditions

Diffuse Large B Cell Lymphoma

Multiple Myeloma

Study ID

NCT06323447

Start date

Dec 15, 2025

Status verified date

Oct, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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 Design

Enrollment

210 participants

Anticipated

Interventions and Outcome Measures

Interventions

PointCheck

Binary classification of severe neutropenia

Primary outcome measure

  • PointCheck Accuracy [ Time Frame: Two weeks ]

Central Contacts and Locations

Central contacts

Alvaro Sanchez-Ferro, MD, PhD

+1 617 419 0974alvaro@leuko.io

Locations

University of Hawaii Cancer Center

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Toshiake Iwase, MD

808-356-5799study@leuko.io

Norton Healthcare Cancer Center

Recruiting

Louisville, Kentucky, United States, 40241

Contacts

Don Stevens, MD

502-899-3366study@leuko.io

Massachussetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Patrick Connor Johnson, MD

866-493-1612study@leuko.io

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Andrew Ip, MD

551-996-5855study@leuko.io

MDA

Recruiting

Houston, Texas, United States, 77030

Contacts

Chijioke Nze, MD

713-792-2860study@leuko.io

More Information

Sponsor

Leuko Labs, Inc.

Last update posted

Nov 3, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-04. This information was provided to ClinicalTrials.gov by Leuko Labs, Inc. on 2026-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.