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

Study Overview
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Brief Summary
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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.

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

Conditions
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B-cell Non-Hodgkin Lymphoma, Aggressive

Intervention / Treatment
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* Other: collected at pre-treatment tumor biopsy
* Other: Peripheral blood tests
* Device: PET/CT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with aggressive B-cell Non-Hodgkin lymphoma<br>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<br>* to identify the tumor-specific clonotype<br>Other: Peripheral blood tests<br>* for MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month).<br>Device: PET/CT<br>* at 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNA Sequencing, 15-180