NCT02633111 · ACTIVE NOT RECRUITING

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

This study looks at whether a blood test can spot aggressive B-cell lymphoma coming back after first-round chemotherapy. The test reads tumor DNA left in the blood. Researchers want to know if it could someday replace follow-up CT scans. It is an observational study with no new drug, and no phase was listed.

Eligibility criteria

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.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-11-04

View full record on ClinicalTrials.gov

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