MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Ce… (NCT07517705) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma
United States50 participantsStarted 2026-06-12
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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 to receive or have received one cycle of R-chemoimmunotherapy.
✓. Planned to receive 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
✓. Availability of sufficient and viable baseline FFPE tumor tissue to allow development of a personalized MRD assay
Exclusion criteria
✕. Limited stage DLBCL, requiring less than 3 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
What they're measuring
1
Feasibility of MRD-Adapted Low-Dose Radiation Therapy
Timeframe: From initiation of study treatment through completion of frontline therapy (approximately 6 months)