MRD-Adapted Low-Dose Radiation Therapy During Frontline Chemoimmunotherapy for Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT07517705
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low-Dose Radiation Therapy (LDRT) — 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 — 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

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.

Key Dates

Start date
Jun 12, 2026
Status verified
Mar 2026
Primary completion
Nov 12, 2030
Completion
Nov 12, 2032

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm- A: MRD-Detectable with Protocol-Directed LDRT Consideration
    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.
  • Active Comparator: Arm- B: MRD-Undetectable Standard Therapy
    Patients with undetectable ctDNA MRD after cycle 2 of frontline chemoimmunotherapy continue standard systemic therapy without the addition of radiation therapy.

Primary Outcome Measure

Feasibility of Real-Time MRD-Guided Treatment Strategy [ Time Frame: From initiation of study treatment through completion of frontline therapy (approximately 6 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred & Pamela Buffet Cancer CenterOmahaNebraska68198
Snegha Ananth, MBBS
[email protected]
(402)559-3848

Find similar trials in Omaha, NE

By research site
Fred & Pamela Buffet Cancer Center· Omaha, NE

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