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Gral. Univ. Gregorio Maranon","Madrid","28007",{"type":41,"coordinates":797},[798,799],-3.70256,40.4165,{"lat":799,"lon":798},{"facility":802,"status":35,"city":794,"state":30,"zip":803,"country":780,"cosmosGeoPoint":804,"geoPoint":806,"contacts":30},"Hospital Infantil Universitario Nino Jesus","28009",{"type":41,"coordinates":805},[798,799],{"lat":799,"lon":798},{"facility":808,"status":35,"city":794,"state":30,"zip":809,"country":780,"cosmosGeoPoint":810,"geoPoint":812,"contacts":30},"Hosp Univ Fund Jimenez Diaz","28040",{"type":41,"coordinates":811},[798,799],{"lat":799,"lon":798},{"facility":814,"status":35,"city":815,"state":30,"zip":816,"country":780,"cosmosGeoPoint":817,"geoPoint":821,"contacts":30},"Clinica Univ. de Navarra","Pamplona","31008",{"type":41,"coordinates":818},[819,820],-1.64323,42.81687,{"lat":820,"lon":819},{"facility":823,"status":35,"city":824,"state":30,"zip":825,"country":780,"cosmosGeoPoint":826,"geoPoint":830,"contacts":30},"Hosp Clinico Univ de Salamanca","Salamanca","37007",{"type":41,"coordinates":827},[828,829],-5.66388,40.96882,{"lat":829,"lon":828},{"facility":832,"status":35,"city":833,"state":30,"zip":834,"country":780,"cosmosGeoPoint":835,"geoPoint":839,"contacts":30},"Hosp. Virgen Del Rocio","Seville","41013",{"type":41,"coordinates":836},[837,838],-5.97317,37.38283,{"lat":838,"lon":837},{"facility":841,"status":35,"city":842,"state":30,"zip":843,"country":780,"cosmosGeoPoint":844,"geoPoint":848,"contacts":30},"Hosp. Clinico Univ. de Valencia","Valencia","46010",{"type":41,"coordinates":845},[846,847],-0.37966,39.47391,{"lat":847,"lon":846},{"facility":850,"status":35,"city":851,"state":30,"zip":852,"country":853,"cosmosGeoPoint":854,"geoPoint":858,"contacts":30},"China Medical University Hospital","Taichung","404327","Taiwan",{"type":41,"coordinates":855},[856,857],120.6839,24.1469,{"lat":857,"lon":856},{"facility":860,"status":35,"city":861,"state":30,"zip":862,"country":853,"cosmosGeoPoint":863,"geoPoint":867,"contacts":30},"National Cheng Kung University Hospital","Tainan","704",{"type":41,"coordinates":864},[865,866],120.21333,22.99083,{"lat":866,"lon":865},{"facility":869,"status":35,"city":870,"state":30,"zip":871,"country":853,"cosmosGeoPoint":872,"geoPoint":876,"contacts":30},"National Taiwan University Hospital","Taipei","10043",{"type":41,"coordinates":873},[874,875],121.52639,25.05306,{"lat":875,"lon":874},{"facility":878,"status":35,"city":879,"state":30,"zip":880,"country":881,"cosmosGeoPoint":882,"geoPoint":886,"contacts":30},"University Hospital of Wales","Cardiff","CF14 4XW","United Kingdom",{"type":41,"coordinates":883},[884,885],-3.18,51.48,{"lat":885,"lon":884},{"facility":888,"status":35,"city":889,"state":30,"zip":890,"country":881,"cosmosGeoPoint":891,"geoPoint":895,"contacts":30},"Leeds Teaching Hospitals NHS Trust","Leeds","LS9 7TF",{"type":41,"coordinates":892},[893,894],-1.54785,53.79648,{"lat":894,"lon":893},{"facility":897,"status":35,"city":898,"state":30,"zip":899,"country":881,"cosmosGeoPoint":900,"geoPoint":904,"contacts":30},"The Clatterbridge Cancer Centre","Liverpool","L7 8YA",{"type":41,"coordinates":901},[902,903],-2.97794,53.41058,{"lat":903,"lon":902},{"facility":906,"status":35,"city":907,"state":30,"zip":908,"country":881,"cosmosGeoPoint":909,"geoPoint":913,"contacts":30},"Guys and St Thomas NHS Foundation Trust","London","SE1 9RT",{"type":41,"coordinates":910},[911,912],-0.12574,51.50853,{"lat":912,"lon":911},{"facility":915,"status":35,"city":907,"state":30,"zip":916,"country":881,"cosmosGeoPoint":917,"geoPoint":919,"contacts":30},"University College London Hospitals","W1T 7HA",{"type":41,"coordinates":918},[911,912],{"lat":912,"lon":911},{"facility":921,"status":35,"city":922,"state":30,"zip":923,"country":881,"cosmosGeoPoint":924,"geoPoint":928,"contacts":30},"The Christie Nhs Foundation Trust","Manchester","M20 4BX",{"type":41,"coordinates":925},[926,927],-2.23743,53.48095,{"lat":927,"lon":926},{"facility":930,"status":35,"city":931,"state":30,"zip":932,"country":881,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"Oxford University Hospitals NHS Trust","Oxfordshire","OX3 7LE",{"facility":934,"status":35,"city":935,"state":30,"zip":936,"country":881,"cosmosGeoPoint":937,"geoPoint":941,"contacts":30},"University Hospitals Plymouth NHS Trust","Plymouth","PL6 8DH",{"type":41,"coordinates":938},[939,940],-4.14305,50.37153,{"lat":940,"lon":939},{"type":943,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100424796",false,"NCT04811560","A Phase 1\u002F2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)","A Phase 1\u002F2, First-in-Human Study of the Menin-KMT2A (MLL1) Inhibitor Bleximenib in Participants With Acute Leukemia (cAMeLot-1)","cAMeLot-1","Inclusion Criteria:\n\nPhase 1:\n\n* Age 2 years to less than (\\\u003C) 18 years of age (pediatric cohort only), all other cohorts 18 years and above\n* Relapsed or refractory (R\u002FR) acute leukemia and has exhausted, or is ineligible for, available therapeutic options\n* Acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 gene (NPM1) or nucleoporin 98 gene or nucleoporin 214 gene (NUP98 or NUP214) alterations\n\nPhase: 2\n\n* Participants greater than 18 years are eligible\n* Must have had an initial diagnosis of acute myeloid leukemia (AML) per the WHO 2022 classification criteria and have relapsed\u002Frefractory disease\n* AML harboring KMT2A-r (gene rearrangement\u002Ftranslocation) or NPM1 mutations only\n\nFor Both Phase 1 and 2:\n\n* Pretreatment clinical laboratory values meeting the following criteria: (a) Hematology: white blood cell (WBC) count \\\u003C= 20\\*10\\^9\u002Fliter (L) and (b) renal function; For adult participants, estimated or measured glomerular filtration rate \\>= 30 milliliter per minute (mL\u002Fmin) per four variable MDRD equation. For pediatric participants an estimated or measured glomerular filtration rate \\>=40 mL\u002Fmin per the CKiD (Chronic Kidney Disease in Children) Schwartz formula\n* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1 or 2. Pediatric participants only: Performance status \\>=70 by Lansky scale (for participants \\\u003C 16 years of age) or \\>=70 Karnofsky scale (for participants \\>=16 years of age)\n* A female of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment\n* Participant must agree to all protocol required contraception requirements and avoid sperm or egg donations or freezing for future reproductive use while on study and for 90 days (males) or 6 months (females) after the last dose of study treatment\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia, diagnosis of Down syndrome associated leukemia or juvenile myelomonocytic leukemia according to World Health Organization (WHO) 2016 criteria\n* Active central nervous system (CNS) disease\n* Prior solid organ transplantation\n* QTc according to Fridericia's formula (QTcF) for males \\>= 450 millisecond (msec) or for females \\>= 470 msec. Participants with a family history of Long QT syndrome are excluded\n* Exclusion criteria related to stem cell transplant: a. Received prior treatment with allogenic bone marrow or stem cell transplant \\\u003C=3 months before the first dose of study treatment ; b. Has evidence of graft versus host disease; c. Received donor lymphocyte infusion \\\u003C=1 month before the first dose of study treatment; d. Requires immunosuppressant therapy (exception: daily doses \\\u003C=10 milligrams (mg) prednisone or equivalent are allowed for adrenal replacement)\n* Prior cancer immunotherapy within 4 weeks prior to enrollment or blinatumomab within 2 weeks prior to enrollment. Additional prior cancer therapies must not be given within 4 weeks prior to enrollment or 5 half-lives of the agent (whichever is shorter)","ALL","2 Years",{"count":954,"type":955},420,"ESTIMATED","INTERVENTIONAL",[958,959],"PHASE1","PHASE2","The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\\[s\\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.",[962],"Acute Leukemia","2026-06-04",{"date":965,"type":966},"2026-06-08","ACTUAL",{"date":968,"type":966},"2021-05-19",{"date":970,"type":955},"2030-09-22",{"name":5,"class":6},102]