{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["acalabrutinib"]],"indication":"Richter's syndrome","name":"STELLAR","nct_id":"NCT03899337","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=stellar-nct03899337. 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":"STELLAR","arms":[{"description":"Arm in the randomised trial. CHOP-R chemoimmunotherapy will continue for up to 6 cycles (each cycle is 21 days), and will be given according to the following schedule:\n\nRituximab, 375 mg/m2, IV infusion, OD, 6 cycles, days of cycle: 1 Cyclophosphamide, 750 mg/m2, IV bolus, OD, 6 cycles, days of cycle: 1 Doxorubicin, 50 mg/m2, IV bolus, OD, 6 cycles, days of cycle: 1 Vincristine, 1.4 mg/m2, IV infusion, OD, 6 cycles, days of cycle: 1 Prednisolone, 40 mg/m2, PO, OD, 6 cycles, days of cycle: 1-5","label":"Standard of Care Arm (CHOP-R)","type":"ACTIVE_COMPARATOR"},{"description":"Arm in the randomised trial. CHOP-R chemoimmunotherapy will continue for up to 6 cycles (each cycle is 21 days), and will be given according to the following schedule:\n\nRituximab, 375 mg/m2, IV infusion, OD, 6 cycles, days of cycle: 1 Cyclophosphamide, 750 mg/m2, IV bolus, OD, 6 cycles, days of cycle: 1 Doxorubicin, 50 mg/m2, IV bolus, OD, 6 cycles, days of cycle: 1 Vincristine, 1.4 mg/m2, IV infusion, OD, 6 cycles, days of cycle: 1 Prednisolone, 40 mg/m2, PO, OD, 6 cycles, days of cycle: 1-5\n\nAcalabrutinib 100 mg, PO, BD will be taken on days 6-21, of each cycle - up to cycle 6. Acalabrutinib treatment will be continuous thereafter until disease progression toxicity, patient choice or death.","label":"Experimental Arm (CHOP-R + Acalabrutinib)","type":"EXPERIMENTAL"},{"description":"Registration arm in platform study. Patients registered to Cohort 1 will receive 100 mg acalabrutinib monotherapy, twice daily, continuously from day 1 until disease progression, toxicity, patient choice or death.","label":"Cohort 1 - Acalabrutinib Monotherapy - Platform Trial","type":"EXPERIMENTAL"},{"description":"Registration arm in platform study. CHOP-R chemoimmunotherapy will continue for up to 6 cycles (each cycle is 21 days), and will be given according to the following schedule:\n\nRituximab, 375 mg/m2, IV infusion, OD, 6 cycles, days of cycle: 1 Cyclophosphamide, 750 mg/m2, IV bolus, OD, 6 cycles, days of cycle: 1 Doxorubicin, 50 mg/m2, IV bolus, OD, 6 cycles, days of cycle: 1 Vincristine, 1.4 mg/m2, IV infusion, OD, 6 cycles, days of cycle: 1 Prednisolone, 40 mg/m2, PO, OD, 6 cycles, days of cycle: 1-5\n\nAcalabrutinib 100 mg, PO, BD will be taken on days 6-21, of each cycle - up to cycle 6. Acalabrutinib treatment will be continuous thereafter until disease progression toxicity, patient choice or death.","label":"Cohort 2 - CHOP-R + Acalabrutinib - Platform Trial","type":"EXPERIMENTAL"}],"collaborators":["Bloodwise","AstraZeneca"],"completion_date":{"date":"2028-07-31","type":"ESTIMATED"},"conditions":["Richter Syndrome"],"enrollment":{"count":72,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Acalabrutinib","otherNames":[],"type":"DRUG"},{"name":"Cyclophosphamide","otherNames":[],"type":"DRUG"},{"name":"Doxorubicin","otherNames":[],"type":"DRUG"},{"name":"Vincristine","otherNames":[],"type":"DRUG"},{"name":"Prednisolone","otherNames":["Pevanti"],"type":"DRUG"},{"name":"Rituximab","otherNames":["Mabthera"],"type":"DRUG"}],"last_update":"2026-08-07","lead_sponsor":"University of Birmingham","official_title":"A Phase II, Randomised Study of CHOP-R in Combination With Acalabrutinib Compared to CHOP-R in Patients With Newly Diagnosed Richter's Syndrome and a Platform for Initial Investigations Into Activity of Novel Treatments in Relapsed/Refractory and Newly Diagnosed Richter's Syndrome.","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2028-06-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Randomised Component - Progression free survival (PFS)","timeFrame":"Time from randomisation to the date of progression or death from any cause, whichever came first, assessed up to 24 months.."},{"measure":"Registration Arm - Cohort 1 - Overall Response","timeFrame":"Response assessed at 24 weeks of treatment"},{"measure":"Registration Arm - Cohort 2 - Overall Response","timeFrame":"Response assessed after 6 cycles of treatment. Each cycle is 21 days."}],"references":[{"citation":"Appleby N, Eyre TA, Cabes M, Jackson A, Boucher R, Yates F, Fox S, Rawstron A, Hillmen P, Schuh A. The STELLAR trial protocol: a prospective multicentre trial for Richter's syndrome consisting of a randomised trial investigation CHOP-R with or without acalabrutinib for newly diagnosed RS and a single-arm platform study for evaluation of novel agents in relapsed disease. BMC Cancer. 2019 May 20;19(1):471. doi: 10.1186/s12885-019-5717-y.","pmid":"31109313","type":"BACKGROUND"},{"citation":"Klintman J, Appleby N, Stamatopoulos B, Ridout K, Eyre TA, Robbe P, Pascua LL, Knight SJL, Dreau H, Cabes M, Popitsch N, Ehinger M, Martin-Subero JI, Campo E, Mansson R, Rossi D, Taylor JC, Vavoulis DV, Schuh A. Genomic and transcriptomic correlates of Richter transformation in chronic lymphocytic leukemia. Blood. 2021 May 20;137(20):2800-2816. doi: 10.1182/blood.2020005650.","pmid":"33206936","type":"DERIVED"}],"start_date":{"date":"2019-07-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Trial of CHOP-R Therapy, With or Without Acalabrutinib, in Patients With Newly Diagnosed Richter's Syndrome","url":"https://clinicaltrials.gov/study/NCT03899337"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/stellar-nct03899337"}