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CLL Experience and Data

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Available evidence shows that MRD may help identify the true kinetics of the disease

Dig deeper into the clinical pathways using the green dots

Initial Diagnosis

Perform Clonality (ID) assessment from sample taken at time of diagnosis to establish patient-specific sequences to track throughout the course of treatment and to determine IGHV* mutation status

  • Use a fresh blood or marrow sample collected prior to initiation of treatment
  • Utilize clonoSEQ to enable parallel processing of IGHV mutation analysis and clonality (ID) assessment from a single specimen

the value of mrd

*IGHV testing is available as a CLIA-validated LDT and has not been cleared or approved by the FDA.

Fixed-Duration Combination Therapy

  • Assess MRD at months 6 and 9 of a 12-month regimen
  • Assess MRD at end of therapy

Follow-up Phase

  • Implement an MRD surveillance plan that is suitable to your patients’ treatment goals and disease characteristics

Determining disease kinetics

Initial Diagnosis

Perform Clonality (ID) assessment from sample taken at time of diagnosis to establish patient-specific sequences to track throughout the course of treatment and to determine IGHV* mutation status

  • Use a fresh blood or marrow sample collected prior to initiation of treatment
  • Utilize clonoSEQ to enable parallel processing of IGHV mutation analysis and clonality (ID) assessment from a single specimen

the value of mrd

*IGHV testing is available as a CLIA-validated LDT and has not been cleared or approved by the FDA.

Fixed-Duration Combination Therapy

  • Assess MRD at months 6 and 9 of a 12-month regimen
  • Assess MRD at end of therapy

Follow-up Phase

  • Implement an MRD surveillance plan that is suitable to your patients’ treatment goals and disease characteristics

Determining disease kinetics

Initial Diagnosis

Perform Clonality (ID) assessment from sample taken at time of diagnosis to establish patient-specific sequences to track throughout the course of treatment and to determine IGHV* mutation status

  • Use a fresh blood or marrow sample collected prior to initiation of treatment
  • Utilize clonoSEQ to enable parallel processing of IGHV mutation analysis and clonality (ID) assessment from a single specimen

the value of mrd

*IGHV testing is available as a CLIA-validated LDT and has not been cleared or approved by the FDA.

Chemoimmunotherapy

  • Assess MRD in peripheral blood at interim staging (typically after cycle 3 of a 6-cycle regimen)
  • Assess MRD in peripheral blood or bone marrow again at final staging (typically 2-3 months after the beginning of the last treatment cycle)

Download case study

Follow-up Phase

  • Implement an MRD surveillance plan that is suitable to your patients’ treatment goals and disease characteristics

Determining disease kinetics

*At least once 3 months post-treatment to determine disease kinetics; every 3-6 months thereafter for surveillance.

On an annual basis for surveillance.

Adaptive Biotechnologies does not recommend or endorse any particular course of treatment.

Other testing approaches may be medically appropriate and final testing decisions should be made by the patient’s healthcare provider. The results obtained from the clonoSEQ® Assay should always be used in combination with the clinical examination, patient medical history, and other findings.

FIXED-DURATION PATHWAYCIT PATHWAY

Clinical vignette: Setting and monitoring treatment goals

Patient Scenario

68-year-old male with intermediate-risk cytogenetics and no significant comorbidities

Physician and patient agree to aim for treatment goal of undetectable MRD at a level of <1 CLL cell in 1 million total cells (U-MRD6) using clonoSEQ

Clonality ID assessment at diagnosis using a fresh blood sample established patient-specific sequences to track

May 2019
Defining goals: Physician and patient make shared decision to initiate 1 year of fixed-duration venetoclax + obinutuzumab with a goal of U-MRD6.

November 2019-February 2020
Assessing response: Physician assesses MRD at months 6 and 9 of 1-year regimen to determine disease kinetics.

May 2020
Monitoring disease: At the end of fixed-duration venetoclax + obinutuzumab, the patient achieves U-MRD by clonoSEQ and is counseled on the potential length of remission. The physician and patient agree to monitor disease with clonoSEQ every 6 months.

Adaptive Biotechnologies does not recommend or endorse any particular course of treatment.

Download CLL case Study

Data show clonoSEQ is prognostic of
progression-free survival in CLL

clonoSEQ reveals that MRD-positive patients have an almost 7x higher event risk than patients with U-MRD16

MRD above 10-5 was associated with an increased risk of progression.

clonoSEQ reveals that MRD-positive patients have an almost 7x higher event risk than patients with U-MRD16

MRD above 10-5 was associated with an increased risk of progression.

About the study

CLL14 study assessed the combination of G + Ven vs G + Clb in previously untreated CLL patients with coexisting conditions. MRD was assessed in PB samples from 337 patients 3 months after completion of fixed-duration therapy (12 months) using an MRD threshold of 10-5.


clonoSEQ may identify disease burden in patients that are MRD-negative by multiparameter flow cytometry (MFC)16,17

Of 90 MFC MRD-negative patients, 71 (79%) had residual disease identified by clonoSEQ.

About the study

MRD was assessed using 4-color MFC and clonoSEQ in a total of 109 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).

About the study

MRD was assessed using 4-color MFC and clonoSEQ in a total of 109 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).


clonoSEQ predicts outcomes in both BM and PB samples16

MRD negativity using either sample type was able to predict longer PFS.

About the study

Data derived from a phase 2 study of 111 CLL patients receiving FCR as frontline therapy. Of 111 patients, 75 provided BM and 62 provided PB. Twenty-six patients provided both PB and BM. U-MRD was defined as <10-6. Kaplan-Meier curves show PFS according to U-MRD (<10-6) or MRD ≥10-6 in blood (first) and BM (second).1

Advanced MRD assessment starts today

Contact Adaptive about ordering clonoSEQ
through our single-site laboratory.

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NCCN Guidelines®

Clinical Practice Guidelines recommend MRD testing in CLL

NCCN Guidelines for chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL)2

MRD assessment:

  • ASO-PCR and 6-color flow cytometry (MRD flow) are the 2 validated methods used for the detection of MRD at the level of 10-4 to 10-5
  • Next-generation DNA sequencing (NGS)-based assays have been shown to be more sensitive, thus allowing for the detection of MRD at the level of 10-6
  • MRD evaluation should be performed using an assay with sensitivity of 10-4 according to the standardized ERIC method or standardized NGS method

Evidence from clinical trials suggests that undetectable MRD in the peripheral blood after the end of treatment is an important predictor of treatment efficacy.

visit the NCCN website

NCCN makes no warranties of any kind whatsoever regarding its content, use, or application and disclaims any responsibility for how its content is applied or used, in any way.


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.
  • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma V.4.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed July 27, 2021. 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.
  • Al-Sawaf O, et al. ASH 2020. Abstract 127. https://ash.confex.com/ash/2020/webprogram/Paper136977.html
  • Al-Sawaf O, et al. ASH 2020. Abstract 1310. https://ash.confex.com/ash/2020/webprogram/Paper134865.html
  • ClinicalTrials.gov. NCT04560322. Accessed June 4, 2021.
  • Hallek M, et al. Blood. 2018;131(25):27‌45-27‌60.
  • Eichhorst B, et al. Lancet Oncol. 2016;17(7):92‌8-9‌42.
  • Goede V, et al. N Engl J Med. 2014;370(12):11‌01-11‌10.
  • Hillmen P, et al. Lancet. 2015;385(9980):18‌73-18‌83.
  • Fischer K, et al. J Clin Oncol. 2012;30(26):32‌09-32‌16.
  • Thompson P, et al. Leukemia. 2018;32(11):2‌388-23‌98.
  • Thompson P, et al. Blood. 2019;134(22):195‌1-19‌59.
  • Strati P, et al. Blood. 2014;123(24):37‌27-373‌2.
  • Böttcher S, et al. J Clin Oncol. 2012;30(9):9‌80-98‌8.
  • Hallek M, et al. Lancet. 2010;376(9747):1‌164-11‌74.
  • clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020. https://clonoseq.com/technical-summary
  • Data on File. Adaptive Biotechnologies. 2020.