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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02633111

Enrollment

501

Registered

2015-12-17

Start date

2015-10-31

Completion date

2026-10-31

Last updated

2025-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aggressive, B-cell Non-Hodgkin Lymphoma

Keywords

DNA Sequencing, 15-180

Brief summary

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.

Interventions

OTHERcollected at pre-treatment tumor biopsy

to identify the tumor-specific clonotype

OTHERPeripheral blood tests

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

DEVICEPET/CT

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026