DNA Sequencing-Based Monitoring of Minimal Residual Disease to Predict Clinical Relapse in Aggressive B-cell Non-Hodgkin Lymphomas
NCT ID: NCT02633111
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
501 participants
OBSERVATIONAL
2015-10-31
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
collected at pre-treatment tumor biopsy
to identify the tumor-specific clonotype
Peripheral blood tests
for MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month).
PET/CT
at 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month)
Interventions
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collected at pre-treatment tumor biopsy
to identify the tumor-specific clonotype
Peripheral blood tests
for MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month).
PET/CT
at 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month)
Eligibility Criteria
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Inclusion Criteria
* 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
* Stage I or II disease.
* Primary mediastinal B-cell lymphoma.
* Transformation from antecedent or coincident indolent B-cell Non-Hodgkin lymphoma.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
M.D. Anderson Cancer Center
OTHER
University of Pennsylvania
OTHER
University of Miami
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Anita Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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University of Miami
Miami, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
Harrison, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Md Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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15-180
Identifier Type: -
Identifier Source: org_study_id
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