Clinical trial · Interventional
MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma
Feasibility of MRD-Adapted Mid-Cycle Low-Dose Radiation Combined With Frontline R-Chemoimmunotherapy in Diffuse Large B-Cell Lymphoma (MRD XRT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-Dose Radiation Therapy (LDRT) | Radiation | — | UNRESOLVED |
| Standard Frontline Chemoimmunotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm- A: MRD-Detectable with Protocol-Directed LDRT Consideration
- description
- Patients with detectable circulating tumor DNA minimal residual disease (ctDNA MRD) after cycle 2 of frontline chemoimmunotherapy and residual PET-avid disease may receive low-dose radiation therapy (LDRT) to PET-positive sites in addition to standard systemic therapy.
- interventionNames
- Radiation: Low-Dose Radiation Therapy (LDRT)
- Other: Standard Frontline Chemoimmunotherapy
- type
- ACTIVE_COMPARATOR
- label
- Arm- B: MRD-Undetectable Standard Therapy
- description
- Patients with undetectable ctDNA MRD after cycle 2 of frontline chemoimmunotherapy continue standard systemic therapy without the addition of radiation therapy.
- interventionNames
- Other: Standard Frontline Chemoimmunotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults ≥19 years of age 2. 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. 3. Planned to receive 6 cycles of frontline R-chemoimmunotherapy for diseases mentioned in criterion 2 4. Presence of measurable disease on imaging, nodal lesion \>1.5cm or extra-nodal lesion \>1 cm prior to initiation of R-chemoimmunotherapy 5. Availability of sufficient and viable baseline FFPE tumor tissue to allow development of a personalized MRD assay Exclusion Criteria: 1. Limited stage (Ann Arbor stage I-II) DLBCL, requiring less than 6 cycles of R-chemoimmunotherapy 2. Primary or secondary CNS lymphoma 3. 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 4. Pregnant and lactating patients 5. Has received two or more cycles of R-chemoimmunotherapy relating to this disease
References
Publications (0)
Data not yet available