{"preliminary_commentary":{"by_channel":{"x_thread":6,"youtube":3,"podcast":2},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03384654\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"name":"DELPHINUS","nct_id":"NCT03384654","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=delphinus-nct03384654. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Cohort 1 will include participants with B cell ALL/LL in second or greater relapse or refractory to at least 2 prior induction regimens. Participant will receive daratumumab in combination with vincristine and prednisone.","label":"Cohort 1: B-Cell Acute Lymphoblastic Leukemia (ALL)/LL","type":"EXPERIMENTAL"},{"description":"Cohort 2 will include participants with T-cell ALL/LL in first relapse or refractory to at least 1 prior induction/consolidation regimen. Participant will receive daratumumab in combination with vincristine, prednisone, doxorubicin and peg-asparaginase in Cycle 1 and daratumumab in combination with cyclophosphamide, cytarabine, 6- mercaptopurine and methotrexate in Cycle 2.","label":"Cohort 2: T-Cell ALL/LL","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2022-09-27","type":"ACTUAL"},"conditions":["Precursor Cell Lymphoblastic Leukemia-Lymphoma"],"enrollment":{"count":47,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Daratumumab","otherNames":[],"type":"DRUG"},{"name":"Vincristine","otherNames":[],"type":"DRUG"},{"name":"Prednisone","otherNames":[],"type":"DRUG"},{"name":"Doxorubicin","otherNames":[],"type":"DRUG"},{"name":"Peg-asparaginase","otherNames":[],"type":"BIOLOGICAL"},{"name":"Cyclophosphamide","otherNames":[],"type":"DRUG"},{"name":"Cytarabine","otherNames":[],"type":"DRUG"},{"name":"6-mercaptopurine","otherNames":[],"type":"DRUG"},{"name":"Methotrexate","otherNames":[],"type":"DRUG"}],"last_update":"2025-05-25","lead_sponsor":"Janssen Research & Development, LLC","official_title":"An Open-label, Multicenter, Phase 2 Study Evaluating the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Subjects >=1 and <=30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2022-09-22","type":"ACTUAL"},"primary_outcomes":[{"measure":"Cohort 1: Percentage of Participants With Complete Response (CR) for B-cell Acute Lymphoblastic Leukemia (ALL)","timeFrame":"Up to 2 cycles, that is, up to 56 days (each cycle of 28-days)"},{"measure":"Cohort 2: Percentage of Participants With Complete Response (CR) for T-cell ALL","timeFrame":"End of Cycle 1 (that is, up to 28 days)"}],"references":[{"citation":"Bhatla T, Hogan LE, Teachey DT, Bautista F, Moppett J, Velasco Puyo P, Micalizzi C, Rossig C, Shukla N, Gilad G, Locatelli F, Baruchel A, Zwaan CM, Bezler NS, Rubio-San-Simon A, Taussig DC, Raetz EA, Mao ZJ, Wood BL, Alvarez Arias D, Krevvata M, Nnane I, Bandyopadhyay N, Lopez Solano L, Dennis RM, Carson R, Vora A. Daratumumab in pediatric relapsed/refractory acute lymphoblastic leukemia or lymphoblastic lymphoma: the DELPHINUS study. Blood. 2024 Nov 21;144(21):2237-2247. doi: 10.1182/blood.2024024493.","pmid":"39158071","type":"DERIVED"},{"citation":"Ruhayel SD, Valvi S. Daratumumab in T-cell acute lymphoblastic leukaemia: A case report and review of the literature. Pediatr Blood Cancer. 2021 May;68(5):e28829. doi: 10.1002/pbc.28829. Epub 2020 Nov 27. No abstract available.","pmid":"33245179","type":"DERIVED"}],"start_date":{"date":"2018-05-14","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma","url":"https://clinicaltrials.gov/study/NCT03384654"},"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/delphinus-nct03384654"}