{"preliminary_commentary":{"by_channel":{"x_thread":4,"podcast":1},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":false},"name":"LOTIS-9","nct_id":"NCT05144009","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=lotis-9-nct05144009. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"LOTIS-9","arms":[{"description":"Participants who are unfit (per sGA) will receive Lonca-R for 3 cycles. Participants who achieve a complete response (CR) will receive Lonca-R for 1 additional cycle. Participants who achieve a partial response (PR) will receive Lonca-R for 3 additional cycles.\n\nLonca-R will be administered as rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and loncastuximab tesirine 150 µg/kg on Day 2 of Cycle 1. During Cycle 2, Lonca-R will be administered as rituximab\\* 375 mg/m\\^2 and loncastuximab tesirine 150 µg/kg on Day 1. For cycles 3 and beyond, Lonca-R will be administered as rituximab 375 mg/m\\^2 and loncastuximab tesirine 75 µg/kg on Day 1.\n\n\\*subcutaneous rituximab 1400mg/dose may be used during Cycle 2 and beyond","label":"Cohort A : Loncastuximab Tesirine + Rituximab (Lonca-R)","type":"EXPERIMENTAL"},{"description":"Participants who are frail (per sGA) or participants with cardiac comorbidities will receive Lonca-R for 3 cycles. Participants who achieve a CR will receive Lonca-R for 1 additional cycle. Participants who achieve a PR will receive Lonca-R for 3 additional cycles for a total of up to 6 cycles. Only participants enrolled in Cohort B, who achieve stable disease (SD) and deriving clinical benefit per the treating physician, may also receive Lonca-R for an additional 3 cycles.\n\nLonca-R will be administered as rituximab 375 mg/m\\^2 on Day 1 of Cycle 1 and loncastuximab tesirine 150 µg/kg on Day 2 of Cycle 1. During Cycle 2, Lonca-R will be administered as rituximab\\* 375 mg/m\\^2 and loncastuximab tesirine 150 µg/kg on Day 1. For cycles 3 and beyond, Lonca-R will be administered as rituximab 375 mg/m\\^2 and loncastuximab tesirine 75 µg/kg on Day 1.\n\n\\*subcutaneous rituximab 1400mg/dose may be used during Cycle 2 and beyond","label":"Cohort B : Loncastuximab Tesirine + Rituximab (Lonca-R)","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-01-22","type":"ACTUAL"},"conditions":["Diffuse Large B-cell Lymphoma"],"enrollment":{"count":41,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Loncastuximab Tesirine","otherNames":["Zynlonta","ADCT-402"],"type":"DRUG"},{"name":"Rituximab","otherNames":[],"type":"DRUG"}],"last_update":"2025-01-30","lead_sponsor":"ADC Therapeutics S.A.","official_title":"A Phase 2 Open-label Study of Loncastuximab Tesirine in Combination With Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients With Diffuse Large B-cell Lymphoma (DLBCL) (LOTIS-9)","overall_status":"TERMINATED","phases":["PHASE2"],"primary_completion_date":{"date":"2024-01-22","type":"ACTUAL"},"primary_outcomes":[{"measure":"CR Rate","timeFrame":"Up to a maximum of 17.1 months"},{"measure":"Cohort B: Percentage of Participants Who Completed 4 Cycles of Treatment","timeFrame":"Up to 12 weeks (3 week cycle length)"}],"references":[{"citation":"Nair R, Kumar A, Chapman AE, Levy MY, Sharman JP, Choudhary Y, Jehangir W, Melear JM, Urban A, Niewarowski A, Wang L, Toukam M, Burke JM, Westin JR. Loncastuximab and Rituximab in Elderly Unfit/Frail Patients With Previously Untreated Diffuse Large B-Cell Lymphoma. Blood Adv. 2026 Oct 15:bloodadvances.2026020494. doi: 10.1182/bloodadvances.2026020494. Online ahead of print.","pmid":"42879743","type":"DERIVED"}],"start_date":{"date":"2022-06-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)","url":"https://clinicaltrials.gov/study/NCT05144009"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/lotis-9-nct05144009"}