Acute LeukemiaNCT05035615
Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer
An observational study of Acute Leukemia, run by Becton, Dickinson and Company at 8 sites in 5 countries.
Trial summary
This study is a multi-site, prospective performance study to determine equivalency between the investigational OneFlow Acute Leukemia Panel on the FACSLyric system versus the final clinical diagnosis. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- IUO Acute Leukemia Panel
- How many people
- 332 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 2 Nov 2021to 18 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A minimum of evaluable 200 remnant/leftover peripheral blood and bone marrow specimens from routine flow cytometry laboratory testing for specimens from subjects 3 Years and older having or suspected of having acute leukemia disorders , myelodysplastic syndrome (MDS), and other hematological or non-hematological disorders. Specimens from healthy subjects will be excluded. At least 100 specimens must have abnormal lymphoid or myeloid cells, at least 100 must have normal lymphoid and myeloid cells.
Who may be able to join
- Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
- Specimen with adequate volume (1 mL) to complete protocol tests.
- Specimen is leftover PB and BM from routine flow cytometry laboratory testing for having or suspected of having acute leukemia disorders (i.e. AML, BCP-ALL, ALAL, etc.), myelodysplastic syndrome (MDS), other hematological, or non-hematological disorders.
- Specimen from newly diagnosed or relapsed subject.
- Only one specimen type (PB or BM) shall be enrolled per given subject.
- Specimen is stored at room temperature, upon receipt by the site.
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- Specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
- Age of specimen (BCP ALL T1: time of collection to start of first pre-wash; ALOT, AML T1-T4: time of collection to start of staining): ≤ 24 hours.
- Specimens are from subjects irrespective of race, gender, and ethnicity
Who cannot join
- Specimen is from healthy subject.
- Specimen from subject <3 years of age.
- Specimen is from subject undergoing any treatment for any form of leukemia.
- Specimen is from subject with minimal residual disease (MRD) as determined by the site.
- Specimen is from subject suspected of plasma cell disorders.
- Visibly clotted specimen.
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- Visibly hemolyzed specimen.
- Frozen specimen.
- Refrigerated specimen.
- Fixed specimen.
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United States4 sites
University Of North Carolina
Chapel Hill, North Carolina, 27514
Childrens Hospital Los Angeles
Los Angeles, California, 90027
New York-Presbyterian Hospital Weill Cornell Medicine
New York, New York, 10065
CorePath Laboratories
San Antonio, Texas, 78229
Czechia1 site
Motol University Hospital, Childhood Leukemia Investigation
Prague
About this study
Official title: Evaluation of the BD OneFlow Acute Leukemia Panel (BD OneFlow ALOT, BCP-ALL T1, and AML T1-T4) on the BD FACSLyric Flow Cytometer Using Leftover, De-identified Specimens
This study is a multi-site, prospective performance study to determine equivalency between the investigational OneFlow Acute Leukemia Panel on the FACSLyric system versus the final clinical diagnosis.
Read the detailed description
Hematology laboratories rely on flow cytometry technology (in addition to classic hematological methods) to aid in screening, diagnosing, and monitoring patients with hematological disorders. High speed and broad applicability of flow cytometry allows for the diagnosis. Currently, there are no consensus panels being used; consequently, the leukemia \& lymphoma (L\&L) testing remains a single-vial antibody being used, with various in-house laboratory developed tests (LDTs) being used to test patient specimens. Furthermore, the analysis of flow cytometer generated data is not standardized and requires a high level of expertise and training for interpretation of complex data. Therefore, optimized and standardized immunostaining protocols for the diagnosis, classification, and prognostic sub-classification of hematological malignancies are needed.
Enrollment will occur at up to 8 investigational sites . Data will be acquired from Eligible remnant/leftover specimens on the BD FACSLyric flow cytometer and evaluated by site personnel and expert analysts .
The final diagnosis and the affected cell population will be determined by site standard of care .
Analysis of data will evaluate identification of 1) normal vs abnormal cell populations and 2) BCP-ALL, AML, and less certain diseases by the expert \& site analysts as compared to the final diagnosis.
- Conditions
- Acute Leukemia
- Being tested
- IUO Acute Leukemia Panel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUO Acute Leukemia PanelDiagnostic test
This Investigational Panel , comprised of 6 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of immature hematopoietic cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, B-cell acute lymphoblastic leukemia or acute myeloid leukemia.
| Study group | Role | What they receive |
|---|---|---|
| Remnant/ Leftover specimens | Specimens that meet inclusion/exclusions criteria, are leftover from routine flow cytometry testing, and are from subjects having or suspected of having a hematological or non-hematological disorder. Receives: Diagnostic Test: IUO Acute Leukemia Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis (Sensitivity Analysis)
Determine equivalence between the investigational OneFlow Acute Leukemia Panel on the BD FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (lymphoid and myeloid) or Abnormal (neoplastic lymphoid or myeloid) phenotypes.
Sensitivity will be calculated
Measured: Within 24 Hours of specimen collection
Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis (Specificity Analysis)
Determine equivalence between the investigational OneFlow Acute Leukemia Panel on the BD FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (lymphoid and myeloid) or Abnormal (neoplastic lymphoid or myeloid) phenotypes.
Specificity will be calculated
Measured: Within 24 Hours of specimen collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start2 Nov 2021
- Primary completion29 Jun 2024
- Study completion18 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Imelda Omana-Zapata, MD, PHD, Study director, Becton, Dickinson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035615
- Sponsor's protocol ID
- CAS-OFLYRICALL-IVDR
- Status last verified
- Oct 2023
- First submitted
- 27 Aug 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the BD OneFlow Acute Leukemia Panel (BD OneFlow ALOT, BCP-ALL T1, and AML T1-T4) on the BD FACSLyric Flow Cytometer Using Leftover, De-identified Specimens
- ClinicalTrials.gov ID
- NCT05035615
- Acronym / sponsor ID
- CAS-OFLYRICALL-IVDR
- Conditions
- Acute Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 332 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 18 Jul 2024 (actual)
- First posted
- 5 Sep 2021 (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.
This study is a multi-site, prospective performance study to determine equivalency between the investigational OneFlow Acute Leukemia Panel on the FACSLyric system versus the final clinical diagnosis.
Detailed description
Hematology laboratories rely on flow cytometry technology (in addition to classic hematological methods) to aid in screening, diagnosing, and monitoring patients with hematological disorders. High speed and broad applicability of flow cytometry allows for the diagnosis. Currently, there are no consensus panels being used; consequently, the leukemia \& lymphoma (L\&L) testing remains a single-vial antibody being used, with various in-house laboratory developed tests (LDTs) being used to test patient specimens. Furthermore, the analysis of flow cytometer generated data is not standardized and requires a high level of expertise and training for interpretation of complex data. Therefore, optimized and standardized immunostaining protocols for the diagnosis, classification, and prognostic sub-classification of hematological malignancies are needed.
Enrollment will occur at up to 8 investigational sites . Data will be acquired from Eligible remnant/leftover specimens on the BD FACSLyric flow cytometer and evaluated by site personnel and expert analysts .
The final diagnosis and the affected cell population will be determined by site standard of care .
Analysis of data will evaluate identification of 1) normal vs abnormal cell populations and 2) BCP-ALL, AML, and less certain diseases by the expert \& site analysts as compared to the final diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remnant/ Leftover specimens | – | Diagnostic Test: IUO Acute Leukemia PanelSpecimens that meet inclusion/exclusions criteria, are leftover from routine flow cytometry testing, and are from subjects having or suspected of having a hematological or non-hematological disorder. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A minimum of evaluable 200 remnant/leftover peripheral blood and bone marrow specimens from routine flow cytometry laboratory testing for specimens from subjects 3 Years and older having or suspected of having acute leukemia disorders , myelodysplastic syndrome (MDS), and other hematological or non-hematological disorders. Specimens from healthy subjects will be excluded. At least 100 specimens must have abnormal lymphoid or myeloid cells, at least 100 must have normal lymphoid and myeloid cells.
Key inclusion criteria (9 listed)
- Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
- Specimen with adequate volume (1 mL) to complete protocol tests.
- Specimen is leftover PB and BM from routine flow cytometry laboratory testing for having or suspected of having acute leukemia disorders (i.e. AML, BCP-ALL, ALAL, etc.), myelodysplastic syndrome (MDS), other hematological, or non-hematological disorders.
- Specimen from newly diagnosed or relapsed subject.
- Only one specimen type (PB or BM) shall be enrolled per given subject.
Key exclusion criteria (10 listed)
- Specimen is from healthy subject.
- Specimen from subject <3 years of age.
- Specimen is from subject undergoing any treatment for any form of leukemia.
- Specimen is from subject with minimal residual disease (MRD) as determined by the site.
- Specimen is from subject suspected of plasma cell disorders.
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 |
|---|---|---|
| IUO Acute Leukemia PanelThis Investigational Panel , comprised of 6 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of immature hematopoietic cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, B-cell acute lymphoblastic leukemia or acute myeloid leukemia. | Diagnostic test | Remnant/ Leftover specimens |
Primary outcome
Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis (Sensitivity Analysis)
Time frame: Within 24 Hours of specimen collection
Determine equivalence between the investigational OneFlow Acute Leukemia Panel on the BD FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (lymphoid and myeloid) or Abnormal (neoplastic lymphoid or myeloid) phenotypes. Sensitivity will be calculated
Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis (Specificity Analysis)
Time frame: Within 24 Hours of specimen collection
Determine equivalence between the investigational OneFlow Acute Leukemia Panel on the BD FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (lymphoid and myeloid) or Abnormal (neoplastic lymphoid or myeloid) phenotypes. Specificity will be calculated
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Imelda Omana-Zapata, MD, PHD study director
Becton, Dickinson and Company
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Leukemia, run by Becton, Dickinson and Company at 8 sites in 5 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Brazil, Czechia, Spain, United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis (Sensitivity Analysis) (time frame: Within 24 Hours of specimen collection). The study lists 2 primary outcomes in all. 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 6 Aug 2024.