This prospective feasibility study evaluates a minimal residual disease (MRD)-adapted treatment strategy in patients with diffuse large B-cell lymphoma (DLBCL) receiving frontline chemoimmunotherapy. Circulating tumor DNA (ctDNA)-based MRD testing and interim positron emission tomography (PET) imaging after two cycles of therapy are used to guide treatment decisions. Patients with detectable MRD may receive low-dose radiation therapy (LDRT) to residual PET-avid disease sites in addition to standard systemic therapy, while patients with undetectable MRD continue standard frontline chemoimmunotherapy. The study aims to assess the feasibility and safety of integrating MRD-guided radiation therapy into frontline treatment of DLBCL.
Adults ≥19 years of age
Biopsy-proven newly diagnosed DLBCL, transformed from indolent lymphoma, Follicular lymphoma grade 3B, post-transplant lymphoproliferative disorder, or any other subtypes of Large B-cell lymphoma under WHO-HAEM5 classification who are eligible and plan to receive 6 cycles of R-chemoimmunotherapy. Note: patients may receive up to one cycle of R-chemoimmunotherapy prior to enrollment.
Planned to receive 6 cycles of frontline R-chemoimmunotherapy for diseases mentioned in criterion 2
Presence of measurable disease on imaging, nodal lesion >1.5cm or extra-nodal lesion >1 cm prior to initiation of R-chemoimmunotherapy
Limited stage (Ann Arbor stage I-II) DLBCL, requiring less than 6 cycles of R-chemoimmunotherapy
Primary or secondary CNS lymphoma
Subject has exceeded maximum lifelong cumulative doses of radiation therapy or is unsafe for radiation therapy as determined by the investigator and/or radiation oncologist
Pregnant and lactating patients
Parallel
Low-Dose Radiation Therapy (LDRT)
RadiationLow-dose radiation therapy delivered to residual PET-avid disease sites identified after interim assessment with PET imaging and MRD testing.
Standard Frontline Chemoimmunotherapy
Other interventionStandard-of-care frontline chemoimmunotherapy regimens for diffuse large B-cell lymphoma, including R-CHOP, Pola-R-CHP, DA-EPOCH-R, R-CEOP, or related regimens as determined by the treating physician.
Feasibility of Real-Time MRD-Guided Treatment Strategy
The proportion of enrolled patients who successfully complete protocol-specified ctDNA MRD testing after 2 cycles of frontline chemoimmunotherapy. Among patients with detectable MRD after cycle 2, the proportion who successfully receive protocol-defined low-dose radiation therapy (LDRT).
Overall response rate (ORR), Including Complete Response (CR) and Partial Response (PR) Rates
Proportion of patients achieving complete response (CR) or overall response (CR+PR) based on PET-CT and imaging criteria
Progression-Free Survival (PFS)
Time from initiation of frontline therapy until disease progression or death from any cause. will be analyzed using Kaplan-Meier curves
Overall Survival (OS)
Time from initiation of frontline therapy until death from any cause. will be analyzed using Kaplan-Meier curves
Impact of Low-Dose Radiation Therapy on Delivery of Systemic Chemoimmunotherapy
Assessment of the impact of mid-cycle low dose radiation therapy on the delivery of planned systemic chemoimmunotherapy.
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