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

Active, not recruiting

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

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Patients with aggressive B-cell Non-Hodgkin lymphoma	collected at pre-treatment tumor biopsy	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.
Patients with aggressive B-cell Non-Hodgkin lymphoma	Peripheral blood tests	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.
Patients with aggressive B-cell Non-Hodgkin lymphoma	PET/CT	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.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method

Locations (11): University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Memorial Sloan Kettering Nassau
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Uniondale, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Md Anderson Cancer Center
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Houston, Texas, United States
Mayo Clinic
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Rochester, Minnesota, United States
Memorial Sloan Kettering Basking Ridge
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Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
🇺🇸
Middletown, New Jersey, United States
Memorial Sloan Kettering Commack
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Commack, New York, United States
Memorial Sloan Kettering Westchester
🇺🇸
Harrison, New York, United States
University of Miami
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Miami, Florida, United States
Memorial Sloan Kettering Bergen
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Montvale, New Jersey, United States