DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas

November 3, 2025 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to determine whether a blood test can accurately detect whether if the participant's lymphoma has come back after completion of initial chemotherapy treatment for their aggressive B-cell Non-Hodgkin lymphoma. The purpose of the study is to see if MRD in blood samples can potentially replace CT scans after completion of chemotherapy in the future.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States
        • University of Miami
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, United States, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, United States, 07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Westchester
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Uniondale, New York, United States, 11553
        • Memorial Sloan Kettering Nassau
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team.

Description

Inclusion Criteria:

  • 18 years of age at time of signing informed consent

  • Histology-confirmed aggressive B-cell Non-Hodgkin lymphoma

    • De novo diffuse large B-cell lymphoma (including all subtypes such as primary mediastinal B-cell lymphoma and T-cell rich B-cell lymphoma). According to the 2008 WHO Classification of Hematopoietic and Lymphoid Tumors. These would include double or triple-hit diffuse large B-cell lymphomas with MYC/BCL2 and/or BCL6 gene rearrangements. These cases may be classified as high grade B-cell lymphomas according to the 2017 revision of the WHO Classification of Hematopoietic and Lymphoid Tumors.
  • Recipient of frontline multi-agent chemotherapy (for example, RCHOP, dose adjusted-REPOCH, RCHOP/RICE, RCHOP+investigational agent, etc). Eligible patients will have recently received (≤ 4 months from end of treatment assessment), be actively receiving, or planned to receive frontline chemotherapy in near future (within 3 months of signing consent). A frontline therapy program can include different sequential phases of treatment, including high-dose therapy and autologous stem cell transplantation.
  • Required pre-treatment test specimen from bone marrow, blood, lymph node, or alternate site to identify tumor-specific clonotype.
  • Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and MRD test specimen collection at specified time points.

Exclusion Criteria:

  • Patients receiving 2nd or greater line of therapy.
  • Stage I or II disease.
  • Primary mediastinal B-cell lymphoma.
  • Transformation from antecedent or coincident indolent B-cell Non-Hodgkin lymphoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with aggressive B-cell Non-Hodgkin lymphoma
This is a non-therapeutic protocol aimed to assess the ability of Adaptive clonoSEQ® MRD assay to detect clinical relapse in DLBCLwhen compared to conventional approaches for detecting relapse such as patient-reported symptoms, clinical exams, and CT scans.
Other: collected at pre-treatment tumor biopsy
to identify the tumor-specific clonotype
Other: Peripheral blood tests
for MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month).
Device: PET/CT
at 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRD assay to predict clinical relapse
Time Frame: 2 years
using the Sequenta diagnostic tool prior to detection using the conventional means (clinical exams and scans) in DLBCL patients.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

M.D. Anderson Cancer Center
Mayo Clinic
University of Pennsylvania
University of Miami

Investigators

  • Principal Investigator: Anita Kumar, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimated)

December 17, 2015

Study Record Updates

Last Update Posted (Estimated)

November 4, 2025

Last Update Submitted That Met QC Criteria

November 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-180

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aggressive

Clinical Trials on collected at pre-treatment tumor biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe