[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637034":3},{"organization":4,"armGroups":7,"interventions":35,"overallOfficials":51,"centralContacts":56,"locations":65,"responsibleParty":81,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":41,"enrollmentInfo":97,"targetDuration":41,"studyType":100,"phases":101,"briefSummary":104,"conditions":105,"keywords":41,"overallStatus":107,"whyStopped":41,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University of Utah","OTHER",[8,15,19,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level 1 (starting dose): SD or PD","EXPERIMENTAL","Dose Level 1:\n\n* Loncastuximab tesirine: 0.075 mg\u002Fkg IV every 3 weeks\n* Rituximab: 375 mg\u002Fm2 IV\n\nThis arm included participants who had SD (Stable Disease) or PD (Progressive Disease) after the first 6 weeks of treatment.\n\nLonca-R will be administered for 4 cycles with response assessment at 6 weeks (+\u002F- 1 week) following the last Lonca-R treatment. If they do not achieve a response, they will come off the study but will be monitored for survival.",[13,14],"Drug: Loncastuximab tesirine","Drug: Rituximab or rituximab biosimilar",{"label":16,"type":10,"description":17,"interventionNames":18},"Dose Level 1 (starting dose): PR","Dose Level 1:\n\n* Loncastuximab tesirine: 0.075 mg\u002Fkg IV every 3 weeks\n* Rituximab: 375 mg\u002Fm2 IV\n\nThis arm included participants who had a Partial Response (PR) after the first 6 weeks of treatment.\n\nLonca-R will be administered for 4 cycles with response assessment at 6 weeks (+\u002F- 1 week) following the last Lonca-R treatment. If they achieve PR, they will have the option to receive either rituximab consolidation or R-CHOP (at the physician's discretion).",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Dose Level 1 (starting dose): CR","Dose Level 1:\n\n* Loncastuximab tesirine: 0.075 mg\u002Fkg IV every 3 weeks\n* Rituximab: 375 mg\u002Fm2 IV\n\nThis arm included participants who had a Complete Response (CR) after the first 6 weeks of treatment.\n\nLonca-R will be administered for 4 cycles with response assessment at 6 weeks (+\u002F- 1 week) following the last Lonca-R treatment. If they achieve a CR after 4 cycles of Lonca-R, they will receive rituximab consolidation (SOC).",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Dose Level 2: SD or PD","Dose Level 2:\n\n* Loncastuximab tesirine: 0.15 mg\u002Fkg IV every 3 weeks for the first 2 cycles, then 0.075 mg\u002Fkg starting C3\n* Rituximab: 375 mg\u002Fm2 IV\n\nThis arm included participants who had SD (Stable Disease) or PD (Progressive Disease) after the first 6 weeks of treatment.\n\nLonca-R will be administered for 4 cycles with response assessment at 6 weeks (+\u002F- 1 week) following the last Lonca-R treatment. If they do not achieve a response, they will come off the study but will be monitored for survival.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Dose Level 2: PR","Dose Level 2:\n\n* Loncastuximab tesirine: 0.15 mg\u002Fkg IV every 3 weeks for the first 2 cycles, then 0.075 mg\u002Fkg starting C3\n* Rituximab: 375 mg\u002Fm2 IV\n\nThis arm included participants who had a Partial Response (PR) after the first 6 weeks of treatment.\n\nLonca-R will be administered for 4 cycles with response assessment at 6 weeks (+\u002F- 1 week) following the last Lonca-R treatment. If they achieve PR, they will have the option to receive either rituximab consolidation or R-CHOP (at the physician's discretion).",[13,14],{"label":32,"type":10,"description":33,"interventionNames":34},"Dose Level 2: CR","Dose Level 2:\n\n* Loncastuximab tesirine: 0.15 mg\u002Fkg IV every 3 weeks for the first 2 cycles, then 0.075 mg\u002Fkg starting C3\n* Rituximab: 375 mg\u002Fm2 IV\n\nThis arm included participants who had a Complete Response (CR) after the first 6 weeks of treatment.\n\nLonca-R will be administered for 4 cycles with response assessment at 6 weeks (+\u002F- 1 week) following the last Lonca-R treatment. If they achieve a CR after 4 cycles of Lonca-R, they will receive rituximab consolidation (SOC).",[13,14],[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DRUG","Loncastuximab tesirine","Lonca will be administered by IV at 75µg\u002Fkg every 3 weeks (DL1).",[20,16,9,32,28,24],null,{"type":37,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Rituximab or rituximab biosimilar","Rituximab or rituximab biosimilar will be administered by IV at 375 mg\u002Fm2 on Day 1 of every cycle. Lonca will be administered first, followed by rituximab (with a 30 min wait time between the two agents)",[20,16,9,32,28,24],[47,48,49,50],"RITUXAN","Truxima","Ruxience","Riabni",[52],{"name":53,"affiliation":54,"role":55},"Narendranath Epperla, MD","Huntsman Cancer Institute","PRINCIPAL_INVESTIGATOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":41,"email":61},"Rachel Kingsford","CONTACT","801-585-0115","rachel.kingsford@hci.utah.edu",{"name":53,"role":59,"phone":63,"phoneExt":41,"email":64},"801-585-0255","naren.epperla@hci.utah.edu",[66],{"facility":67,"status":41,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Huntsman Cancer Institute at University of Utah","Salt Lake City","Utah","84112","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-111.89105,40.76078,{"lat":77,"lon":76},[80],{"name":58,"role":59,"phone":60,"phoneExt":41,"email":61},{"type":82,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[84],{"name":85,"class":86},"ADC Therapeutics S.A.","INDUSTRY","100637034","phase-1-loncastuximab-tesirine-and-rituximab-as-first-line-therapy-in-patients-with-post-transplant-lymphoproliferative-disorder-pluto-100637034",false,"NCT07573436","Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)","A Phase 1\u002F2 Study of Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)","PLUTO","Inclusion Criteria:\n\n* Subject aged ≥ 18 years.\n* Histologically confirmed B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; with or without EBV association.\n\n  --Note: Subjects with classic Hodgkin-like PTLD are excluded.\n* Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening\n* ECOG Performance Status ≤ 2.\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3\n    * Platelet count ≥ 75,000\u002Fmm3\n    * Hemoglobin ≥ 8 g\u002FdL\n  * Hepatic:\n\n    * Bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN with document liver involvement and\u002F or Gilbert's disease\n    * Transaminases (AST or ALT) ≤ 3 x ULN or ≤ 5 x ULN with documented liver involvement\n  * Renal:\n\n    * Estimated creatinine clearance ≥ 60 mL\u002Fmin by Cockcroft-Gault formula.\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n  * Women \\\u003C 50 years of age:\n\n    * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and\n    * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or\n    * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n  * Women ≥ 50 years of age:\n\n    * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or\n    * Had radiation-induced menopause with last menses \\>1 year ago; or\n    * Had chemotherapy-induced menopause with last menses \\>1 year ago; or\n    * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n* Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and the lactation requirements as described in Sections 5.4.1 and 5.4.2.\n* Subjects or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial.\n* Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n\nExclusion Criteria:\n\n* PTLD following liquid transplantation\n* CNS involvement\n* Prior treatment for PTLD with the exception of radiation, antivirals, steroids and reduced immunosuppression\n* Human immunodeficiency virus (HIV) infection\n* Major surgery within 4 weeks prior to enrolment\n* History of bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.\n* Subjects with chronic liver disease with hepatic impairment Child-Pugh class C\n* Pregnant or lactating or intending to become pregnant during the study\n* Active autoimmune disease which, in the opinion of the investigator, may negatively impact subject safety or interfere with study participation.\n* The diagnosis of another malignancy which, in the opinion of the investigator, is likely to negatively impact subject safety or interfere with study participation.\n* Significant medical diseases or conditions including those requiring substantial changes in concomitant medications, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to the following conditions:\n\n  * Cardiovascular disorders:\n\n    * Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.\n    * Myocardial infarction (MI) within 6 months before the first dose.\n    * QTc prolongation defined as a QTcF \\> 480 ms.\n    * Congenital long QT syndrome or a corrected QT measure (QTc) interval of \\>480 ms at screening (unless secondary to pacemaker or bundle branch block).\n    * Grade 2 or higher edema (peripheral, pleural or ascites)\n    * Grade 1 or higher pericardial effusion\n  * Severe pulmonary disease\n  * Uncontrolled diabetes mellitus\n  * Severely immunocompromised state\n  * Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.\n* Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at time of screening\n* Subjects with evidence of active hepatitis B infection, based on positive surface antigen or Hepatitis B DNA PCR are excluded. Subjects who are Hepatitis B core antibody positive must take prophylaxis with entecavir or equivalent and be willing to undergo monthly Hepatitis B DNA PCR testing\n* Active hepatitis C infection\n* Grade 2 or higher rash\n* Clinically significant fluid accumulation in the third space\n* Subjects taking prohibited medications as described in Section 6.8.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.","ALL","18 Years",{"count":98,"type":99},23,"ESTIMATED","INTERVENTIONAL",[102,103],"PHASE1","PHASE2","The purpose of phase I of this clinical trial is to learn the recommended dose of the drugs loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD).\n\nThe purpose of phase II of this clinical trial is to learn if the drugs loncastuximab tesirine and rituximab are effective in participants with post-transplant lymphoproliferative disorders (PTLD).",[106],"Post-transplant Lymphoproliferative Disorder","NOT_YET_RECRUITING","2026-04-30",{"date":110,"type":111},"2026-05-07","ACTUAL",{"date":113,"type":99},"2026-06",{"date":115,"type":99},"2031-06",{"name":5,"class":6},1]