{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT04139304","title":"A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma","sponsor":"AIDS Malignancy Consortium","phases":["EARLY_PHASE1"],"status":"RECRUITING","indication":null,"disease":null},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"not published","detail":"This trial's cancer could not be matched to an Open Targets disease.","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T22:05:06.666Z"},"context":[]},{"id":"human_genetic","label":"Human genetic evidence","value":"not published","detail":"This trial's cancer could not be matched to an Open Targets disease.","rule":"Any germline or somatic human genetic evidence for the target in this cancer","source":{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T22:05:06.666Z"},"context":[]},{"id":"pediatric_target","label":"Pediatric target","value":"yes","detail":"CD38 on the FDA list","rule":"Target is on FDA's Pediatric Molecular Target List (relevant targets); membership alone neither requires nor waives a study","source":{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"},"context":[]},{"id":"haematologic","label":"Haematologic cancer","value":"yes","detail":"Haematologic","rule":"From the indication, or the registry conditions when no indication matches","source":{"label":"ClinicalTrials.gov NCT04139304","url":"https://clinicaltrials.gov/study/NCT04139304","date":"2026-11-11T22:05:06.666Z"},"context":[{"figure":"Likelihood of approval from phase 1: 7.5% haematologic vs 4.6% solid","dataset":"BIO / Informa / QLS 2021","years":"2011–2020","caveat":"Population-level, not a prediction."}]}],"facts":[{"label":"Background therapy","text":"Cyclophosphamide, Doxorubicin, Etoposide, Vincristine: standard agents, not counted in these flags."}],"pending":[{"what":"Normal-tissue expression in vital organs","source":"Human Protein Atlas (ticket 36)"},{"what":"Pan-essential in cell lines","source":"DepMap (ticket 36)"},{"what":"Approved drug on this target","source":"Drugs@FDA (ticket 30)"}]},{"n":2,"question":"Can the result be trusted?","flags":[{"id":"randomised","label":"Randomised","value":"no","detail":"Single group","rule":"Registry allocation field","source":{"label":"ClinicalTrials.gov NCT04139304","url":"https://clinicaltrials.gov/study/NCT04139304","date":"2026-11-11T22:05:06.666Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"yes","detail":"15 planned; each patient moves a rate by 100 ÷ 15 = 6.7 points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT04139304","url":"https://clinicaltrials.gov/study/NCT04139304","date":"2026-11-11T22:05:06.666Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"no","detail":"Percentage of newly diagnosed plasmablastic lymphoma patients who complete at least 3 cycles of daratumumab with dose…","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT04139304","url":"https://clinicaltrials.gov/study/NCT04139304","date":"2026-11-11T22:05:06.666Z"},"context":[{"figure":"Non-OS primary endpoint: odds ratio 2.79 for a positive phase 3","dataset":"Otsuka 2021, 400 phase 3 oncology trials","years":"to 2020","caveat":"Shown with the next figure: a surrogate is easier to hit, and often a weak guide to survival."},{"figure":"52% of surrogate-to-OS correlations are low","dataset":"Prasad 2015","years":"published to 2014","caveat":"Shown with the figure above."}]},{"id":"results_overdue","label":"Results overdue","value":"no","detail":"Primary completion expected 2029-07; not yet due","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT04139304","url":"https://clinicaltrials.gov/study/NCT04139304","date":"2026-11-11T22:05:06.666Z"},"context":[]}],"facts":[],"pending":[{"what":"Treated and evaluable counts, assessor, confirmed response, follow-up and data cutoff","source":"Readout extraction (ticket 32)"},{"what":"Primary endpoint changed between registry versions","source":"Registry versions in the store (ticket 32)"}]},{"n":3,"question":"What must it beat?","flags":[],"facts":[],"pending":[{"what":"Control-arm result and approved therapies for the same segment, with label links","source":"Drugs@FDA, FDA labels and readouts (tickets 30, 32)"}]},{"n":4,"question":"Too crowded, or too late?","flags":[],"facts":[{"label":"Stopped on this target","text":"75 terminated, withdrawn or suspended trials of drugs against CD38. Reasons are quoted as the registry gives them on the target page.","source":{"label":"CD38: what already stopped","url":"/target/ENSG00000004468#stopped","date":"2026-11-11T22:05:06.678Z"}}],"pending":[{"what":"Programs on the target by phase and months behind the leader","source":"Programs and Drugs@FDA (ticket 33)"}]},{"n":5,"question":"Can it be approved, and stay approved?","flags":[{"id":"single_country","label":"Single-country","value":"yes","detail":"All 9 sites in United States","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT04139304","url":"https://clinicaltrials.gov/study/NCT04139304?tab=locations","date":"2026-11-11T22:05:06.666Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMEA-002152-PIP01-17-M04 (daratumumab, Treatment of lymphoid malignancies (except mature B-cell neoplasms)): PM: decision on the application for modification of an agreed PIP, 13 Sept 2024; compliance positive 13 Dec 2024; EMEA-002152-PIP03-19 (daratumumab, Treatment of systemic light chain amyloidosis): W: decision granting a waiver in all age groups for all conditions or indications, 18 Mar 2020; EMEA-002152-PIP02-17-M01 (daratumumab, Treatment of lymphoid malignancies (except mature B-cell neoplasms)): PM: decision on the application for modification of an agreed PIP, 12 Jun 2019; EMEA-002043-PIP01-16 (doxorubicin hydrochloride, Treatment of hepatocellular carcinoma): W: decision granting a waiver in all age groups for all conditions or indications, 31 Jan 2017","rule":"An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-paediatric_investigation_plans-output-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_orphan","label":"EU orphan designation","value":"yes","detail":"EU/3/18/2020 withdrawn 25 May 2018: Treatment of AL amyloidosis; EU/3/13/1153 expired 17 Jul 2013: Treatment of plasma-cell myeloma; EU/3/25/3056 positive 22 May 2025: Treatment of soft-tissue sarcoma; EU/3/22/2624 positive 21 Jun 2022: Treatment of soft tissue sarcoma; +5 more","rule":"An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-orphan_designations-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"yes","detail":"Zolsketil pegylated liposomal: authorised since 31 May 2022; Darzalex: authorised since 20 May 2016; Caelyx pegylated liposomal: authorised since 20 Jun 1996; Celdoxome pegylated liposomal: lapsed since 15 Sept 2022; +4 more","rule":"An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"fda_orphan","label":"FDA orphan designation","value":"not published","detail":"FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the link","rule":"Would be: an FDA orphan designation names the drug","source":{"label":"FDA orphan designations search","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/","date":""},"context":[]},{"id":"fda_ped_approval","label":"FDA pediatric oncology approval","value":"yes","detail":"Doxorubicin Hydrochloride, 7 Aug 1974: MULTIPLE; Vincristine Sulfate, date not given: Acute leukemia; MULTIPLE (in combination)","rule":"FDA's Pediatric Oncology Drug Approvals table names the drug","source":{"label":"FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03)","url":"https://www.fda.gov/about-fda/oncology-center-excellence/pediatric-oncology-drug-approvals","date":"2026-11-11T22:05:06.689Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"877 interventional studies of Daratumumab, Doxorubicin Hydrochloride, Vincristine Sulfate include patients under 18; 198 are recruiting, not yet recruiting or active","rule":"The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age","source":{"label":"ClinicalTrials.gov search","url":"https://clinicaltrials.gov/search?intr=%22Daratumumab%22+OR+%22Doxorubicin+Hydrochloride%22+OR+%22Vincristine+Sulfate%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-11T22:05:06.699Z"},"context":[]}],"facts":[{"label":"Caveat","text":"Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where the sites are is a fact about the record, not a judgement of its quality."},{"label":"Rare pediatric disease voucher","text":"FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news.","source":{"label":"FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs","url":"https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs","date":"2026-11-11"}}],"pending":[{"what":"Precedent approvals for target, modality and endpoint; accelerated-approval status","source":"Drugs@FDA and FDA accelerated-approval tables (ticket 30)"}]},{"n":6,"question":"Can the sponsor finish?","flags":[],"facts":[{"label":"Sponsor","text":"AIDS Malignancy Consortium (academic or other)","source":{"label":"ClinicalTrials.gov NCT04139304","url":"https://clinicaltrials.gov/study/NCT04139304","date":"2026-11-11T22:05:06.666Z"}},{"label":"principal investigator","text":"Ariela Noy, MD, Memorial Sloan Kettering Cancer Center","source":{"label":"Person page","url":"/person/Ariela%20Noy%2C%20MD","date":"2026-11-11T22:05:06.666Z"}}],"pending":[{"what":"Filed cash, quarterly spend and the runway arithmetic","source":"SEC XBRL company facts (ticket 37)"},{"what":"Sponsor's completed vs stopped oncology trials and results-reporting record","source":"Registry, by company (ticket 37)"}]}],"limits":"Public records cannot show: sales forecasts; a probability of success for this asset; full deal terms and net prices; FDA designations and action dates before approval (shown only as company-reported); clinical holds unless the company disclosed them; manufacturing; patents on unapproved drugs; whether preclinical findings have been replicated.","sources":[{"label":"ClinicalTrials.gov NCT04139304","url":"https://clinicaltrials.gov/study/NCT04139304","date":"2026-11-11T22:05:06.666Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T22:05:06.666Z"},{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"}]},"source":"ClinicalTrials.gov + Open Targets","fetchedAt":"2026-11-11T22:05:06.662Z"}