CLLFDA-cleared and CLIA-validated in bone marrow and peripheral blood
Serial MRD monitoring with clonoSEQ delivers answers during
fixed-duration treatment and beyond
clonoSEQ can help you track disease kinetics
Monitoring MRD with clonoSEQ provides clinically valuable information at multiple stages of CLL care1-3
Fixed-duration doesn’t mean fixed decisions
Disease kinetics during and after fixed-duration therapy can provide data on disease growth or regression.3
clonoSEQ digs deeper than MFC
At deeper levels, clonoSEQ uncovers more patients with residual disease than MFC4
Clinical practice guidelines and clinical trial experience support MRD monitoring at multiple timepoints1-3,5
| Clinical practice guidelines |
Clinical trial experience |
|
|---|---|---|
| During fixed-duration therapy* | 
|
|
| End of treatment |
|
|
| Periodically following therapy |
|
MRD status is highly prognostic of outcomes following fixed-duration therapy
Different treatment strategies for fixed-duration therapy have been suggested for patients who do not reach uMRD at EoT, including continuation of treatment or treatment intensification.
-Al-Sawaf et al3
Higher Sensitivity and Specificity
clonoSEQ detects disease that MFC cannot
Percentage of patients who were MRD negative by MFC but had residual disease by clonoSEQ
of MFC-negative patients were positive by clonoSEQ at any threshold4
of the MFC-negative patients had disease burden detected by clonoSEQ at >10-4
Even measured at 10-4, clonoSEQ is a stronger detector of residual disease than MFC4
EoT, end of therapy; FCR, fludarabine + cyclophosphamide + rituximab; MFC, multiparameter flow cytometry; OS, overall survival; uMRD, undetectable minimal residual disease.
*MRD following cycles 6 and 9 of fixed duration therapy were protocol-directed measurements from the CLL14 trial.
About the studies
Prognosis and Serial Monitoring
In the phase 3, open-label, randomized CLL14 study, Al-Sawaf et al evaluated rates of undetectable MRD and OS after one-year fixed-duration treatment of Ven-Obi in patients with previously untreated CLL.3
clonoSEQ vs MFC
MRD was assessed using 4-color MFC (10-4) and clonoSEQ (10-6) in a total of 124 samples from a study in newly diagnosed CLL patients who received up to 6 courses of standard FCR conducted at the University of Texas MD Anderson Cancer Center (NCT00759798).4
This page is intended for a US-based audience.
clonoSEQ® is available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). CLL Clonality (ID) Tests will also produce an IGHV status result, which is provided as a CLIA-validated laboratory developed test (LDT) but which has not been cleared or approved by the FDA. Additionally, clonoSEQ is available for use in other lymphoid cancers and specimen types as a CLIA-validated LDT. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.
References
- Al-Sawaf O, et al. Lancet Oncol. 2020;21(9):1188-1200.
- Al-Sawaf O, et al. ASH 2020. Abstract 127. https://ash.confex.com/ash/2020/webprogram/Paper136977.html
- Al-Sawaf O, et al. J Clin Oncol. 2021;39(36):4049-4060.
- Data on file. Adaptive Biotechnologies. 2022.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.3.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed July 1, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
- clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020.