Diffuse Large B Cell LymphomaPC002NCT06323447
Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
An observational study of Diffuse Large B Cell Lymphoma and Multiple Myeloma, run by Leuko Labs, Inc. at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Diffuse Large B Cell Lymphoma, Multiple Myeloma
- What is being tested?
- PointCheck
- How many people
- 210 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 15 Dec 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
Massachussetts General Hospital
Boston, Massachusetts, 02114
Patrick Connor Johnson, MD, 866-493-1612, study@leuko.io
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Andrew Ip, MD, 551-996-5855, study@leuko.io
- Recruiting
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
Toshiake Iwase, MD, 808-356-5799, study@leuko.io
- Recruiting
MDA
Houston, Texas, 77030
Chijioke Nze, MD, 713-792-2860, study@leuko.io
- Recruiting
Norton Healthcare Cancer Center
Louisville, Kentucky, 40241
Don Stevens, MD, 502-899-3366, study@leuko.io
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Joaquín Martinez, MD, +34 913908000, study@leuko.io
About this study
Official title: 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.
- Conditions
- Diffuse Large B Cell Lymphoma, Multiple Myeloma
- Being tested
- PointCheck
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PointCheckDiagnostic test
Binary classification of severe neutropenia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Secondary outcomes (4)
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.
Measured: Two-weeks
PointCheck Usability
Mean System Usability Score
Measured: Two-weeks
PointCheck Errors
Device related errors (number/type)
Measured: Two-weeks
PointCheck Safety
total number (and %) of AEs and SAEs related to the device use.
Measured: Two-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start15 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leuko Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Castro Gonzalez, PhD, Principal investigator, Leuko Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323447
- Sponsor's protocol ID
- PC002
- Acronym
- PC002
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
- ClinicalTrials.gov ID
- NCT06323447
- Acronym / sponsor ID
- PC002 / PC002
- Conditions
- Diffuse Large B Cell Lymphoma, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Leuko Labs, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PointCheckBinary classification of severe neutropenia | Diagnostic test | – |
Primary outcome
PointCheck Accuracy
Time frame: Two weeks
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.
4 secondary outcomes
PointCheck Precision
Time frame: Two-weeks
PointCheck Usability
Time frame: Two-weeks
PointCheck Errors
Time frame: Two-weeks
PointCheck Safety
Time frame: Two-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carlos Castro Gonzalez, PhD principal investigator
Leuko Labs
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B Cell Lymphoma and Multiple Myeloma, run by Leuko Labs, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alvaro Sanchez-Ferro, MD, PhD (+1 617 419 0974, alvaro@leuko.io), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PointCheck Accuracy (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.