Evaluation of the BD OneFlow Acute Leukemia Panel on the BD FACSLyric Flow Cytometer

NCT05035615 | Completed FDA Device

• 1 other identifier: CAS-OFLYRICALL-IVDR
• Study Type: observational
• Target: 332
• Locations: 5 countries
• Sites: 8

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.

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Within 24 Hours of specimen collection

Study Arms (1)

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.

Diagnostic Test: IUO Acute Leukemia Panel

Interventions

IUO Acute Leukemia Panel DIAGNOSTIC_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.

Remnant/ Leftover specimens

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• Visibly hemolyzed specimen.
• Frozen specimen.
• Refrigerated specimen.
• Fixed specimen.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (8)

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

New York-Presbyterian Hospital Weill Cornell Medicine

New York, New York, 10065, United States

Location

University Of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

CorePath Laboratories

San Antonio, Texas, 78229, United States

Location

Fleury Group

São Paulo, 01323--020, Brazil

Location

Motol University Hospital, Childhood Leukemia Investigation

Prague, Czechia

Location

University of Salamanca

Salamanca, 37007, Spain

Location

Cambridge University

Cambridge, CB2 0QQ, United Kingdom

Location

Study Officials

• Imelda Omana-Zapata, MD, PHD

  Becton, Dickinson and Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 5, 2021
• Study Start: November 2, 2021
• Primary Completion: June 29, 2024
• Study Completion: July 18, 2024
• Last Updated: August 6, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4); ES (1); GB (1); CZ (1); BR (1)