BD OneFlow CLPD Panel (BD OneFlow LST, and B-CLPD T1 to T4 Assays) on the BD FACSLyric System.

Clinical Performance Evaluation of the BD OneFlow CLPD Panel (BD OneFlow LST, and B-CLPD T1 to T4 Assays) on the BD FACSLyric System.

Multi-site, prospective performance study to determine equivalency between the investigational CLPD Full Panel on the FACSLyric system versus the final clinical diagnosis.

Study Overview

• Status: Completed
• Conditions: Chronic Lymphoproliferative Diseases (CLPD)
• Intervention / Treatment: Diagnostic test: BD OneFlow LST, and B-CLPD T1 to T4 Assays

Detailed Description

This study is a multi-site and multi-regional prospective performance evaluation to determine sensitivity and specificity of the investigational BD OneFlow CLPD Panel on the FACSLyric system when compared to the results from the Expert Analysis for market launch.

The study will be conducted at up to eight investigational sites that have previously participated in the BD OneFlow program clinical studies and/or have expertise in flow cytometric immunophenotyping, interpretation, and diagnosis of Leukemia and Lymphoma (L&L). Each site will have one 10- or 12-color FACSLyric instrument with Universal Loader (Loader).

This study will enroll at least 250 leftover de-identified PB, BM, and LT specimens from routine flow cytometry laboratory testing for hematological disorders or non-hematological disorders that provide valid results and are considered evaluable specimens. Each site will enroll a minimum of 25 evaluable specimens and a maximum of approximately 70 evaluable specimens with normal and abnormal lymphoid cell immunophenotype.

To ensure that the study satisfies enrollment by specimen type, this study will enroll lymphoid tissue specimens. Lymphoid tissue (LT) refers to organs/tissues supporting immune responses, which includes primary lymphoid tissue (BM and thymus), and secondary lymphoid tissue (lymph nodes, tonsils, spleen, and Peyer's patches). Their morphological structure is related to its function in the immune system. For this study, the term LT will be used to refer the secondary lymphoid tissue only.

Evaluable specimens will be enrolled to meet the binning requirements for specimen type, normal vs abnormal cell phenotype, and disease type, as described in Tables 3-5.

Specimens will be prepared using a minimum of three lots of the OneFlow LST and OneFlow B-CLPD T1 to T4 reagent kits across investigational sites. Stained samples will be acquired on the BD FACSLyric using the BD FACSuite Clinical application with the assay modules for each of the tubes. Results will be analyzed by the laboratory staff. In addition, the sites will collect the "Final Clinical Diagnosis" from each sample.

The study includes an "Expert Analysis." This will be conducted by qualified Experts by training and experience, who will receive the files with raw data, analyze and designate cell immune phenotype. Two Experts will analyze the data from each sample. The results from the Expert Analysis will be compared to the site's Final Clinical Diagnosis and the study acceptance criteria for the study endpoints.

• Study Type: Observational
• Enrollment (Actual): 322

Contacts and Locations

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus Medical Center, Laboratory Medical Immunology, Department of Immunology
• Portugal
  • Lisboa, Portugal
    • Champalimaud Foundation
• Spain
  • Salamanca, Spain
    • University of Salamanca
• Switzerland
  • Aarau, Switzerland
    • Kantonsspital Aarau AG / IfLM
• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of Norht Calolina
  • Texas
    • San Antonio, Texas, United States, 78256
      • CorePATH Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A minimum of evaluable 250 remnant/leftover peripheral blood, bone marrow, and lymph node specimens from routine flow cytometry laboratory testing for hematological disorders. Specimens from healthy subjects will be excluded.

Specimens are from subjects irrespective of race, gender, and ethnicity. Specimen from subject >22 years of age .

Description

Inclusion Criteria:

1. Specimen collected/handled prior to enrollment in accordance with site policies and procedures.
2. Specimen with adequate volume (min 700 µL or more) to complete protocol tests.
3. Specimen is leftover PB, BM, or LT from routine flow cytometry laboratory testing for chronic lymphoproliferative disorders, other hematological disorders, non-hematological tumors (e.g., solid tumors), or other hematological disorders (non-malignant).
4. Specimen is from subjects previous diagnosed, newly diagnosed and/or relapsed disease.
5. Only one type of specimen, either PB, BM, or LT shall be enrolled per given subject.
6. Specimen is stored at room temperature, upon receipt by the site.
7. PB and BM specimens are collected in EDTA (K2 or K3) or heparin (sodium or lithium).
8. LT specimens collected in PBS, culture media (e.g., RPMI-1640), saline, or saline wrapped gauze at the discretion of the Investigator.
9. Age of specimen for PB and BM (time of collection to start of first pre-wash): ≤ 24 hours. (Note: No Age of specimen claim is being made for LT)
10. Specimens are from subjects irrespective of race, gender, and ethnicity

Exclusion Criteria:

1. Specimen is from healthy subject.
2. Specimen is from subject undergoing any treatment for any form of L&L.
3. Specimen from subject <22 years of age.
4. Specimen is from subject with minimal residual disease (MRD) as determined by the site.
5. Specimen is from subject suspected of acute leukemia (e.g., T-ALL, BCP-ALL, AML) or myeloid dysplastic syndrome (MDS).
6. Visibly clotted specimen.
7. Visibly hemolyzed specimen.
8. Frozen specimen.
9. Refrigerated specimen.
10. Fixed specimen.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between expert analysis determination for normal and abnormal specimen and final dignosis	Determine equivalence between the investigational OneFlow CLPD panel on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (T-cell, B-cell, and NK-cell) or Abnormal (T-cell or B-cell or NK-cell) phenotype using leftover, hematologically abnormal specimens.	Age of Specimen for PB and BM (time of collection to start of first pre-washed) <24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison between expert analysis determination for normal and abnormal Peripheral Blood (PB) specimen and final dignosis	Supplement equivalence between the investigational OneFlow CLPD on FACSLyric system results analyzed by two independent experts versus the final clinical diagnosis for Normal (T-cell, B-cell, and NK-cell) or Abnormal (T-cell or B-cell or NK-cell) phenotype using leftover, hematologically abnormal peripheral blood (PB) specimens.	ge of Specimen for PB (time of collection to start of first pre-washed) <24 hours.

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Study Director: Imelda Omana-Zapata, MD, Ph.D, Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Actual): May 8, 2024
• Study Completion (Actual): May 8, 2024

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoproliferative Disorders
• Other Study ID Numbers: CAS-OFLBT1T4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No