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Pediatric ALL Experience and Data

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Data support monitoring of patients throughout the disease continuum1-6

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 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

Guidelines suggest assessing MRD following induction therapy

If patient is MRD-positive post-induction, consider intensified consolidation with additional therapy, blinatumomab or tisagenlecleucel

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Standard Consolidation

Guidelines suggest assessing MRD following consolidation therapy

Hematopoietic Stem Cell Transplant (HSCT)

In patients undergoing transplant, consider MRD monitoring post-transplant

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Surveillance

  • Regardless of whether patient undergoes transplant, continue to measure MRD via bone marrow during post-treatment surveillance (every 6-12 months)
  • Consider interim MRD assessments in peripheral blood (eg, between bone marrow assessments) if more frequent monitoring is desired

Prognostic value pre- and post-transplant

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.

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Clinical vignette: Tracking MRD over time

Patient Scenario

Pre-adolescent male diagnosed with B-cell acute lymphoblastic leukemia. Physician decided to monitor disease burden with a goal of achieving MRD negativity by clonoSEQ (<10-6)

At initiation of induction therapy, clonoSEQ ID test identified dominant DNA sequence(s)

After induction therapy, patient remained MRD-positive. Patient received unrelated donor transplant in March 2017

March 2018
Assessing response post-transplant: Patient is MRD-negative 1-year post-transplant. Physician initiates quarterly peripheral blood* assessments.

March-December 2018
Monitoring disease: Patient remains MRD-negative by clonoSEQ in the peripheral blood for 9 months.

March 2019
Detecting molecular relapse: Two years post-HSCT, low-level MRD in peripheral blood identified. Physician confirms rising MRD in bone marrow.

April 2019
Detecting relapse: Low-level recurrence. Patient enrolled in CAR T trial.

*Testing for validated sample types other than bone marrow (in B-ALL, myeloma, CLL) and peripheral blood (in CLL) is available via Adaptive’s CLIA-validated LDT service. Other sample types have not been cleared or approved by the FDA.

Download pediatric ALL case Study

Peer-reviewed data show how clonoSEQ can be used to stratify risk in this vulnerable population

In pediatric ALL patients before transplant, clonoSEQ provided more prognostic value than multiparameter flow cytometry (MFC)2

clonoSEQ MRD detection pre-allogeneic transplant predicted relapse and OS significantly better than MFC.

Probability curves of patients who were MRD-negative or -positive by MFC or clonoSEQ assessed pre-transplant.

About the study

NGS-MRD (10-6) was performed on pre-transplant BM samples from 41 patients with B-cell ALL enrolled in the COG ASCT0431 trial to determine whether the increased sensitivity of NGS-MRD better identifies pre- and post-HSCT relapse risk vs 6-color MFC (10-4).


In pediatric ALL patients after transplant, clonoSEQ was better at predicting relapse than MFC2

clonoSEQ offers predictive power at Day 30 and beyond.

At Day 30 post-transplant, MFC was unable to distinguish between patients who ultimately relapsed and those who did not.

At Day 30 post-transplant, the better predictive power of clonoSEQ is demonstrated.

About the study

BM samples from 112 pediatric patients were analyzed by MFC and 53 pediatric patients’ BM was analyzed by clonoSEQ 1, 3, and 8 months post-HSCT.


Compared to patients who were MRD-negative by both methods, those who were clonoSEQ MRD-positive/MFC MRD-negative had poorer outcomes7

MFC missed 4 out of 10 patients who were MRD-positive by clonoSEQ.

About the study

Study evaluated MRD in the BM of 579 pediatric B-ALL patients from the (COG) trials AALL0331 or AALL0232. The threshold for MFC and clonoSEQ was 10-4 (1:10,000). MRD was assessed post-induction.

Advanced MRD assessment starts today

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NCCN Guidelines®

Clinical Practice Guidelines recommend MRD testing in pediatric ALL

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines)1

Diagnostic workup
Baseline characterization of leukemic clone to facilitate subsequent MRD analysis

MRD assessment:

  • MRD is an essential component of patient evaluation over the course of sequential therapy
  • If validated MRD assessment technology with appropriate sensitivity is not available locally, commercial tests are available
  • Studies in both children and adults with ALL have demonstrated the strong correlation between MRD and risk for relapse, as well as the prognostic significance of MRD measurements during and after initial induction therapy
  • Additional MRD assessment time points should be guided by the regimen used

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). 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 Pediatric Acute Lymphoblastic Leukemia V.1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed November 4, 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.
  • Pulsipher M, et al. Blood. 2015;125(22):35‌01-35‌08.
  • Sala Torra O, et al. Biol Blood Marrow Transplant. 2017;23(4):691-696.
  • Logan A, et al. Biol Blood Marrow Transplant. 2014;20(9):1307-13.
  • Muffly L, et al. ASH 2020; Abstract 975.
  • Pulsipher M, et al. ASH 2018; Abstract 1551.
  • Wood B, et al. Blood. 2018;131(12):1350-1359.