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NCT Number: NCT02633111

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

B-Cell Non-Hodgkin Lymphoma Aberrant Motor Behavior in Dementia Aggression Aggressive Behavior Behavioral Symptoms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

collected at pre-treatment tumor biopsy

Other

to identify the tumor-specific clonotype

Peripheral blood tests

Other

for MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month).

PET/CT

Device

at 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

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

Registry information

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2015
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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