Assessment of Clonotypic Rearrangements and Minimal Residual Disease in Lymphoid Malignancies.

Context.—: Measurable (minimal) residual disease (MRD) is an independent prognostic factor for survival outcomes in patients with lymphoid and plasma cell malignancies and has been incorporated into consensus criteria regarding treatment response, strategy, and clinical trial endpoints. clonoSEQ (a next-generation sequencing [NGS]-MRD assay) uses multiplex polymerase chain reaction and NGS to identify clonotypic rearrangements at the immunoglobulin (Ig) H, IgK, IgL, T-cell receptor (TCR)-β, and TCR-γ loci, as well as translocated B-cell lymphoma 1/IgH and 2/IgH sequences for MRD assessment. Additionally, it can be used to confirm diagnoses of cutaneous T-cell lymphoma (CTCL).
Objective.—: To review the technical aspects of our experience using the clonoSEQ Assay in routine clinical practice.
Design.—: In this single-center experience, 390 patients with lymphoid and plasma cell malignancies were assessed with the NGS-MRD Assay at a central laboratory.
Results.—: Median time from arrival of the shipment to initiation of the assay (defined as captured in Adaptive's secure tracking system) was 2.1 hours. Overall, 317 patients had 1 or more samples submitted for sequence identification. Of these, 290 (91.5%) had trackable sequences identified. The median calibration rate of samples by malignancy (where n ≥ 10 samples, excluding CTCL samples) was 88.1%, across a variety of fresh and archived sample sources (177 of 201 samples). TCR-β and/or TCR-γ clonotypes were identified in 40 of 95 samples (42.1%) from 66 patients with suspected CTCL.
Conclusions.—: This NGS-MRD Assay is a valuable and sensitive tool for monitoring MRD in patients with plasma cell and lymphoid malignancies and assisting in the diagnosis of CTCL.
Competing Interests: Hussaini declares participating on advisory councils or committees for, and receiving honoraria from, Adaptive Biotechnologies Corp and consulting fees from Amgen. Srivastava and Lee are employees of, and hold stocks/shares with, Adaptive Biotechnologies Corp. Shah declares participating on advisory councils or committees for Adaptive Biotechnologies Corp. Pinilla-Ibarz declares receipt of honoraria from Adaptive Biotechnologies Corp. Shain declares receiving honoraria from Amgen, Inc, and consulting fees from Adaptive Biotechnologies Corp. Alsina has no relevant financial interest in the products or companies described in this article.