Clinical trial NCT05035615: Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Leukemia
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 332
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
2. Specimen with adequate volume (1 mL) to complete protocol tests.
3. 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.
4. Specimen from newly diagnosed or relapsed subject.
5. Only one specimen type (PB or BM) shall be enrolled per given subject.
6. Specimen is stored at room temperature, upon receipt by the site.
7. Specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
8. 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.
9. Specimens are from subjects irrespective of race, gender, and ethnicity

Exclusion Criteria:

1. Specimen is from healthy subject.
2. Specimen from subject \<3 years of age.
3. Specimen is from subject undergoing any treatment for any form of leukemia.
4. Specimen is from subject with minimal residual disease (MRD) as determined by the site.
5. Specimen is from subject suspected of plasma cell disorders.
6. Visibly clotted specimen.
7. Visibly hemolyzed specimen.
8. Frozen specimen.
9. Refrigerated specimen.
10. Fixed specimen.

Primary outcomes:
measure: Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis (Sensitivity Analysis)
timeFrame: Within 24 Hours of specimen collection
measure: Comparison between expert analysts' determination of normal and abnormal specimen and final diagnosis (Specificity Analysis)
timeFrame: Within 24 Hours of specimen collection
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: New York
country: United States
facility: New York-Presbyterian Hospital Weill Cornell Medicine
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina
state: North Carolina
city: San Antonio
country: United States
facility: CorePath Laboratories
state: Texas
city: San Paolo
country: Brazil
facility: Fleury Group
city: Prague
country: Czechia
facility: Motol University Hospital, Childhood Leukemia Investigation
city: Salamanca
country: Spain
facility: University of Salamanca
city: Cambridge
country: United Kingdom
facility: Cambridge University
Study officials:
affiliation: Becton, Dickinson and Company
name: Imelda Omana-Zapata, MD, PHD
role: STUDY_DIRECTOR
References: