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

Acute Leukemia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05035615
• Other study ID #: CAS-OFLYRICALL-IVDR
• Status: Recruiting
• Start date: November 2, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: Becton, Dickinson and Company
• Contact: Maryam Saleminik
• Phone: 408-518-5037
• Email: MSaleminik[@]bd.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

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.

Locations

Country	Name	City	State
Brazil	Fleury Group	San Paolo
Czechia	Motol University Hospital, Childhood Leukemia Investigation	Prague
Spain	University of Salamanca	Salamanca
United Kingdom	Cambridge University	Cambridge
United States	University Of North Carolina	Chapel Hill	North Carolina
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	New York-Presbyterian Hospital Weill Cornell Medicine	New York	New York
United States	CorePath Laboratories	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Becton, Dickinson and Company

Countries where clinical trial is conducted

United States,  Brazil,  Czechia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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