MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-Dose Radiation Therapy (LDRT), Standard Frontline Chemoimmunotherapy.
- Who it may be relevant to
- Registry conditions: Diffuse Large B-Cell Lymphoma. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of MRD-Adapted Mid-Cycle Low-Dose Radiation Combined With Frontline R-Chemoimmunotherapy in Diffuse Large B-Cell Lymphoma (MRD XRT)
Overview
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.
Detailed description
Diffuse large B-cell lymphoma (DLBCL) is commonly treated with frontline chemoimmunotherapy regimens such as R-CHOP or related combinations. Early response assessment using positron emission tomography (PET) imaging provides prognostic information but may not fully capture minimal residual disease. Circulating tumor DNA (ctDNA)-based MRD assays allow for sensitive detection of molecular residual disease during treatment.
This study evaluates an MRD-adapted treatment strategy that integrates interim PET imaging and ctDNA MRD testing during frontline therapy for DLBCL. Patients receiving standard-of-care chemoimmunotherapy undergo MRD testing and PET imaging after cycle 2 of treatment. Patients with detectable MRD may receive low-dose radiation therapy (LDRT) directed at residual PET-avid disease sites, while patients with undetectable MRD continue standard therapy without radiation.
Interventions
- Radiation Low-Dose Radiation Therapy (LDRT)
Low-dose radiation therapy delivered to residual PET-avid disease sites identified after interim assessment with PET imaging and MRD testing. - Other Standard Frontline Chemoimmunotherapy
Standard-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.
Primary outcome measures
- Feasibility of Real-Time MRD-Guided Treatment Strategy [Time frame: From initiation of study treatment through completion of frontline therapy (approximately 6 months)]
Secondary outcome measures (5)
- Overall response rate (ORR), Including Complete Response (CR) and Partial Response (PR) Rates [Time frame: From initiation of study treatment through completion of frontline therapy (approximately 6 months)]
- Progression-Free Survival (PFS) [Time frame: From initiation of study treatment until disease progression or death, assessed up to 24 months]
- Overall Survival (OS) [Time frame: From initiation of study treatment until death from any cause, assessed up to 24 months]
- Impact of Low-Dose Radiation Therapy on Delivery of Systemic Chemoimmunotherapy [Time frame: From initiation of study treatment through completion of frontline Chemoimmunotherapy (approximately 6 months)]
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [Time frame: From baseline through end of treatment, assessed up to 24 months]
Eligibility criteria
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 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
- Availability of sufficient and viable baseline FFPE tumor tissue to allow development of a personalized MRD assay
Exclusion criteria
- 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
- Has received two or more cycles of R-chemoimmunotherapy relating to this disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Fred & Pamela Buffet Cancer Center — Omaha
Identifiers
NCT: NCT07517705 · MRD XRT