NCT05035615

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 332 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Leukemia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	IUO Acute Leukemia Panel	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.

Timeline

• Start date: 2021-11-02
• Primary completion: 2024-06-29
• Completion: 2024-07-18
• First posted: 2021-09-05
• Last updated: 2024-08-06

Locations

8 sites across 5 countries: United States, Brazil, Czechia, Spain, United Kingdom

Regulatory

• FDA-regulated device study