[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07517705":3,"trial-entities:NCT07517705":111,"trial-summary:NCT07517705":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":50,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":78,"locations":81,"central_contacts":97,"overall_officials":106,"references":109,"see_also_links":110},"NCT07517705","MRD XRT","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)","NOT_YET_RECRUITING","2032-11-12","2026-03","2026-05-13","2026-06-12","University of Nebraska","OTHER",true,"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.","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.\n\nThis 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.",[19],"Diffuse Large B-Cell Lymphoma",[21,22,23,24,25],"Minimal Residual Disease","ctDNA","PET-CT","MRD-guided therapy","Low-Dose Radiation Therapy","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},50,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"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.",[39],"Arm- A: MRD-Detectable with Protocol-Directed LDRT Consideration",{"type":14,"name":41,"description":42,"armGroupLabels":43},"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.",[39,44],"Arm- B: MRD-Undetectable Standard Therapy",[46],{"measure":47,"description":48,"timeFrame":49},"Feasibility of Real-Time MRD-Guided Treatment Strategy","The proportion of enrolled patients who successfully complete protocol-specified ctDNA MRD testing after 2 cycles of frontline chemoimmunotherapy.\n\nAmong patients with detectable MRD after cycle 2, the proportion who successfully receive protocol-defined low-dose radiation therapy (LDRT).","From initiation of study treatment through completion of frontline therapy (approximately 6 months)",[51,54,58,62,66],{"measure":52,"description":53,"timeFrame":49},"Overall response rate (ORR), Including Complete Response (CR) and Partial Response (PR) Rates","Proportion of patients achieving complete response (CR) or overall response (CR+PR) based on PET-CT and imaging criteria",{"measure":55,"description":56,"timeFrame":57},"Progression-Free Survival (PFS)","Time from initiation of frontline therapy until disease progression or death from any cause. will be analyzed using Kaplan-Meier curves","From initiation of study treatment until disease progression or death, assessed up to 24 months",{"measure":59,"description":60,"timeFrame":61},"Overall Survival (OS)","Time from initiation of frontline therapy until death from any cause. will be analyzed using Kaplan-Meier curves","From initiation of study treatment until death from any cause, assessed up to 24 months",{"measure":63,"description":64,"timeFrame":65},"Impact of Low-Dose Radiation Therapy on Delivery of Systemic Chemoimmunotherapy","Assessment of the impact of mid-cycle low dose radiation therapy on the delivery of planned systemic chemoimmunotherapy.","From initiation of study treatment through completion of frontline Chemoimmunotherapy (approximately 6 months)",{"measure":67,"description":68,"timeFrame":69},"European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)","Patient-reported quality of life assessed using the EORTC QLQ-C30 questionnaire.","From baseline through end of treatment, assessed up to 24 months","ALL","19 Years",null,false,{"inclusion":75,"exclusion":76,"raw_text":77},[],[],"Inclusion Criteria:\n\n1. Adults ≥19 years of age\n2. 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.\n3. Planned to receive 6 cycles of frontline R-chemoimmunotherapy for diseases mentioned in criterion 2\n4. Presence of measurable disease on imaging, nodal lesion \\>1.5cm or extra-nodal lesion \\>1 cm prior to initiation of R-chemoimmunotherapy\n5. Availability of sufficient and viable baseline FFPE tumor tissue to allow development of a personalized MRD assay\n\nExclusion Criteria:\n\n1. Limited stage (Ann Arbor stage I-II) DLBCL, requiring less than 6 cycles of R-chemoimmunotherapy\n2. Primary or secondary CNS lymphoma\n3. Subject has exceeded maximum lifelong cumulative doses of radiation therapy or is unsafe for radiation therapy as determined by the investigator and\u002For radiation oncologist\n4. Pregnant and lactating patients\n5. Has received two or more cycles of R-chemoimmunotherapy relating to this disease",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"Fred & Pamela Buffet Cancer Center","Omaha","Nebraska","68198","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"Snegha Ananth, MBBS","CONTACT","(402)559-3848","sananth@unmc.edu",{"lat":95,"lon":96},41.25626,-95.94043,[98,102],{"name":99,"role":91,"phone":100,"email":101},"Krishna vamsi Gottipati, MS","(402) 5593518","krgottipati@unmc.edu",{"name":103,"role":91,"phone":104,"email":105},"IIT Office Clinical Trails Office","(402) 5590963","IITOFFICE@unmc.edu",[107],{"name":90,"affiliation":13,"role":108},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":116},[19,113,114,115],"Grade 3b Follicular Lymphoma","Large B-cell lymphoma","Post-Transplant Lymphoproliferative Disorder",[],{"nct_id":4,"found":15,"summary":118,"prompt_version":128},{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is a single-arm study, meaning all participants receive the same general treatment approach. It aims to enroll 50 participants and is evaluating a new treatment strategy.","completed","MRD-Adapted Radiation for Diffuse Large B-Cell Lymphoma","This study is looking at a new way to treat diffuse large B-cell lymphoma (DLBCL), a type of cancer that starts in white blood cells. It combines standard chemotherapy (like R-CHOP or similar treatments) with a special approach using low-dose radiation therapy (LDRT). After two cycles of chemotherapy, doctors will check your blood for minimal residual disease (MRD), which means a very small amount of cancer cells that might still be present, and also use PET imaging to see if any cancer remains. If MRD is found, you might receive low-dose radiation to those areas. If no MRD is found, you'll continue with standard chemotherapy. The main goal is to see if this approach is practical and safe. You can join if you are an adult aged 19 or older with newly diagnosed DLBCL and are planning to receive 6 cycles of standard chemotherapy.","The feasibility of the treatment strategy will be measured from the start of treatment through its completion, which is approximately 6 months.",144,"You would receive standard chemotherapy and have blood tests and PET scans after two cycles of treatment. If needed, you might also receive low-dose radiation therapy.","Not stated in the trial record.",[36],"v2"]