What this study is
This prospective Phase IIA feasibility study evaluates a minimal residual disease (MRD)-adapted treatment strategy in patients with diffuse large B-cell lymphoma (DLBCL) receiving frontline R-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 and residual PET-avid or measurable disease suitable for radiation therapy receive protocol-directed low-dose radiation therapy (LDRT) in addition to standard systemic therapy. Patients with undetectable MRD, or detectable MRD without targetable residual disease, continue standard frontline chemoimmunotherapy without protocol-directed LDRT.
What's being tested
- Low-Dose Radiation Therapy (LDRT)
Intervention · RADIATION
Low-dose radiation therapy delivered to residual PET-avid disease sites identified after interim assessment with PET imaging and MRD testing.
- Standard Frontline Chemoimmunotherapy
Intervention · OTHER
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.
Study details
- Official title
- Feasibility of MRD-Adapted Mid-Cycle Low-Dose Radiation Combined With Frontline R-Chemoimmunotherapy in Diffuse Large B-Cell Lymphoma (MRD XRT)
- Sponsor
- University of Nebraska
- Conditions
- Diffuse Large B-Cell Lymphoma
- Enrolling
- 50 people
- Starts
- 2026-12-12
- Est. completion
- 2033-02-12
- Design
- Open-label, non-randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 19 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openFred & Pamela Buffet Cancer Center
Omaha, Nebraska, United States
- Snegha Ananth, MBBS · Contact(402)559-3848sananth@unmc.edu
Study team
Sponsor
University of Nebraska
Study ID 0342-26-FB
Principal investigator
Snegha Ananth, MBBS
University of Nebraska
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.