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adult ALL Experience and Data

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Available evidence shows that clonoSEQ® may help inform treatment decisions at multiple stages of care1-8

Dig deeper into the clinical pathways using the green dots

Initial Diagnosis

Clinical practice guidelines suggest performing a Clonality (ID) assessment from sample taken at time of diagnosis to establish tumor-specific B- and T-cell* receptor DNA sequences to track; use a fresh or archived bone marrow or blood sample collected prior to initiation of treatment

the value of mrd

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

Induction

  • Evaluation of MRD status should be considered upon completion of initial induction
  • In general, MRD positivity at the end of induction predicts high relapse rates and should prompt evaluation for allogeneic hematopoietic cell transplantation (HCT)

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Consolidation

  • Evaluation of MRD status can be considered during post-consolidation surveillance as clinically indicated

Consolidation pre-transplant

Hematopoietic Cell Transplantation (HCT)

In general, MRD positivity at the end of induction/consolidation predicts high relapse rates and should prompt an evaluation for allogeneic HCT

Download case StudiesInforming transplant decisions

Maintenance/Surveillance

Prospective MRD monitoring is recommended for MRD-negative patients in 3- to 6-month intervals during maintenance therapy and follow-up

Concordance between PB and BM samples

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.

Download clinical pathway

Clinical vignette: Detecting MRD in patient treated with blinatumomab

Patient Scenario

Transplant-eligible adult Ph-negative patient with normal karyotype, 70% blasts in bone marrow, and immunophenotype consistent with B-ALL

clonoSEQ ID test identified dominant DNA sequence(s)

Upon initiation of Linker induction with rituximab therapy, the patient achieved a CR but was MRD-positive by clonoSEQ in July 2015

January 2016
Defining goals: After consolidation, patient achieves MRD negativity and proceeds to unrelated donor transplant. Patient remains MRD-negative 60 days post-transplant.

August 2016
Monitoring disease: Low level but rising MRD post-transplant led to immune suppression taper. Patient then becomes MRD-negative.

September 2017
Detecting relapse: Peripheral blood (PB) and confirmatory bone marrow (BM) sample show increasing MRD. Patient initiated blinatumomab therapy.

January 2018
Assessing response: Post-blinatumomab therapy, physician utilizes frequent PB and interim BM MRD assessments. Patient remains MRD-negative by clonoSEQ.

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


View additional real-world case studies that inform care

See how Dr. Jessica Leonard uses MRD to inform decisions in pre-transplant ALL.

watch videosee other case studies

Peer-reviewed data show the prognostic power of clonoSEQ in clinic

In adult ALL patients, clonoSEQ provides greater prognostic value compared to multiparameter flow cytometry (MFC)9

In 25 patients who were MRD-negative by MFC, 17 patients were identified as clonoSEQ MRD-positive. These patients had worse outcomes compared to patients who were MRD-negative by both methods.

About the study

A retrospective study of previously untreated Ph-negative ALL patients (n = 67) who received frontline regimens consisting of either hyper-CVAD-based (n = 44) or lower intensity hyper-CVD-based (n = 23), which was usually combined with inotuzumab ozogamicin, and achieved CR. BM biopsy samples were analyzed for MRD with 6-color MFC (sensitivity: 0.01% [10-4]) and clonoSEQ (sensitivity: 0.0001% [10-6]).


In adult ALL patients, clonoSEQ MRD status based on BM and PB samples is highly concordant10,11

  • MRD monitoring of PB* could be an alternative to frequent BM assessment
  • Across all patients, MRD assessment in peripheral blood was highly correlated with bone marrow (r = 0.87)

  • Disease burden was 6-fold higher in BM compared to PB
  • Discordant samples predominantly had low levels of MRD in the BM (<10-4)

About the studies

Graph 1: One hundred twenty-six paired BM and PB samples from 62 patients with adult ALL who received cellular therapies (HSCT and chimeric antigen receptor [CAR] T cells) were assessed using clonoSEQ.

Graph 2: One hundred fifty-three samples were collected from 32 newly diagnosed adult B-cell ALL patients treated with combination chemotherapy; 54 paired BM and PB samples were available for analysis.

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

Advanced MRD assessment starts today

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NCCN Guidelines®

Clinical Practice Guidelines recommend MRD testing in adult ALL

NCCN Guidelines for adult and AYA patients with ALL1†

Diagnostic workup
Baseline flow cytometric and/or molecular characterization of leukemic clone to facilitate subsequent MRD analysis

MRD assessment:

  • Additional MRD assessment time points should be guided by the regimen used
  • Serial monitoring frequency may be increased in patients with molecular relapse or persistent low-level disease burden
  • Consider periodic MRD monitoring (≥ every 3 months) for patients with complete molecular remission (undetectable levels). Increased frequency may be indicated for detectable levels

visit the NCCN website

The ALL Panel considers AYA to be within the age range of 15-39 years. However, this age is not a firm reference point because some of the recommended regimens have not been comprehensively tested across all ages.

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). clonoSEQ is also available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.

References

  • Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Lymphoblastic Leukemia V.2.2021. © 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.
  • Brüggemann M, et al. Blood. 2006;107(3):11‌16-112‌3.
  • Raff T, et al. Blood. 2007;109(3):910-915.
  • Gökbuget N, et al. Blood. 2012;120(9):186‌8-18‌76.
  • Vidriales MB, et al. Blood. 2003;101(12):46‌95-4‌70‌0.