[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659222":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":27,"overallOfficials":13,"centralContacts":33,"locations":42,"responsibleParty":180,"collaborators":13,"id":182,"slug":183,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":184,"sex":190,"minAge":191,"maxAge":13,"enrollmentInfo":192,"targetDuration":13,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":202,"whyStopped":13,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"Stichting Hemato-Oncologie voor Volwassenen Nederland","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate efficacy in terms of Progression-free survival (PFS)","To evaluate efficacy in terms of Progression-free survival (PFS) at 24 months after first dose of pirtobrutinib.","24 months after first dose of pirtobrutinib.",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","CLL is a chronic disease. Although the treatment is improving all the time, there is still no cure. If the disease comes back patients will receive another treatment, but with each subsequent treatment the disease usually comes back sooner.\n\nThis study investigates a treatment consisting of pirtobrutinib in combination with epcoritamab. Pirtobrutinib has been approved in Europe for the treatment of CLL if the disease comes back after previous treatment. Pirtobrutinib blocks important cancer cell signals. These signals help the cells to divide and survive. It is known that pirtobrutinib is effective in patients who did not respond well to other medicines that work in a similar way (ibrutinib, acalabrutinib and zanubrutinib).\n\nEpcoritamab is what is called a bispecific antibody. This means that it is able to bind to cells that are part of our immune system (T cells) and to tumor cells (CLL cells). This enables epcoritamab to help these T cells recognize and attack the tumor cells. The first studies of epcoritamab in patients with other types of lymphatic cancer have shown that it can be an effective treatment. Epcoritamab has been approved in Europe for certain types of lymphatic cancer where the disease has come back. Epcoritamab has also been studied in CLL patients whose disease has come back and in most cases resulted in decreased CLL with acceptable side effects.",[22],{"label":23,"type":24,"description":23,"interventionNames":25},"Pirtobrutinib combined with epcoritamab","EXPERIMENTAL",[26],"Combination Product: pirtobrutinib combined with epcoritamab",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":13},"COMBINATION_PRODUCT","pirtobrutinib combined with epcoritamab","combination treatment",[23],[34,39],{"name":35,"role":36,"phone":37,"phoneExt":13,"email":38},"Arnon Kater, Prof. dr","CONTACT","+31 20 44 42604","a.p.kater@amsterdamumc.nl",{"name":40,"role":36,"phone":13,"phoneExt":13,"email":41},"Sabina Kersting, dr.","s.kersting@hagaziekenhuis.nl",[43,54,64,72,80,85,93,101,109,117,125,133,141,149,157,162,170],{"facility":44,"status":13,"city":45,"state":13,"zip":13,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":13},"DK-Copenhagen-Rigshospitalet","Copenhagen","Denmark","DK",{"type":49,"coordinates":50},"Point",[51,52],12.56553,55.67594,{"lat":52,"lon":51},{"facility":55,"status":13,"city":56,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":63,"contacts":13},"NL-Almere-Flevoziekenhuis","Almere Stad","Netherlands","NL",{"type":49,"coordinates":60},[61,62],5.21413,52.37025,{"lat":62,"lon":61},{"facility":65,"status":13,"city":66,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":67,"geoPoint":71,"contacts":13},"NL-Amersfoort-Meander MC","Amersfoort",{"type":49,"coordinates":68},[69,70],5.3875,52.155,{"lat":70,"lon":69},{"facility":73,"status":13,"city":74,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":75,"geoPoint":79,"contacts":13},"NL-Amsterdam-AUMC","Amsterdam",{"type":49,"coordinates":76},[77,78],4.88969,52.37403,{"lat":78,"lon":77},{"facility":81,"status":13,"city":74,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":82,"geoPoint":84,"contacts":13},"NL-Amsterdam-OLVG",{"type":49,"coordinates":83},[77,78],{"lat":78,"lon":77},{"facility":86,"status":13,"city":87,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":88,"geoPoint":92,"contacts":13},"NL-Breda-Amphia ziekenhuis","Breda",{"type":49,"coordinates":89},[90,91],4.77596,51.58656,{"lat":91,"lon":90},{"facility":94,"status":13,"city":95,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":96,"geoPoint":100,"contacts":13},"NL-Doetinchem-Slingeland","Doetinchem",{"type":49,"coordinates":97},[98,99],6.28889,51.965,{"lat":99,"lon":98},{"facility":102,"status":13,"city":103,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":104,"geoPoint":108,"contacts":13},"NL-Dordrecht-ASZ","Dordrecht",{"type":49,"coordinates":105},[106,107],4.67361,51.81,{"lat":107,"lon":106},{"facility":110,"status":13,"city":111,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":112,"geoPoint":116,"contacts":13},"NL-eindhoven-Maxima MC","Eindhoven",{"type":49,"coordinates":113},[114,115],5.47778,51.44083,{"lat":115,"lon":114},{"facility":118,"status":13,"city":119,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":120,"geoPoint":124,"contacts":13},"NL-Groningen-Martini Ziekenhuis","Groningen",{"type":49,"coordinates":121},[122,123],6.56667,53.21917,{"lat":123,"lon":122},{"facility":126,"status":13,"city":127,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":128,"geoPoint":132,"contacts":13},"NL-Hoofdorp-Spaarne Gasthuis","Hoofddorp",{"type":49,"coordinates":129},[130,131],4.68889,52.3025,{"lat":131,"lon":130},{"facility":134,"status":13,"city":135,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":136,"geoPoint":140,"contacts":13},"NL-Leeuwarden-Frisius MC","Leeuwarden",{"type":49,"coordinates":137},[138,139],5.80973,53.20271,{"lat":139,"lon":138},{"facility":142,"status":13,"city":143,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":144,"geoPoint":148,"contacts":13},"NL-Nieuwegein-Antonius Ziekenhuis","Nieuwegein",{"type":49,"coordinates":145},[146,147],5.08056,52.02917,{"lat":147,"lon":146},{"facility":150,"status":13,"city":151,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":152,"geoPoint":156,"contacts":13},"NL-Rotterdam-Ikazia ziekenhuis","Rotterdam",{"type":49,"coordinates":153},[154,155],4.47917,51.9225,{"lat":155,"lon":154},{"facility":158,"status":13,"city":151,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":159,"geoPoint":161,"contacts":13},"NL-Rotterdam-Maasstad Ziekenhuis",{"type":49,"coordinates":160},[154,155],{"lat":155,"lon":154},{"facility":163,"status":13,"city":164,"state":13,"zip":13,"country":57,"countryCode":58,"cosmosGeoPoint":165,"geoPoint":169,"contacts":13},"NL-Den Haag-HMC","The Hague",{"type":49,"coordinates":166},[167,168],4.29861,52.07667,{"lat":168,"lon":167},{"facility":171,"status":13,"city":172,"state":13,"zip":13,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":13},"SE-Orebro-Orebro UH","Örebro","Sweden","SE",{"type":49,"coordinates":176},[177,178],15.2066,59.27412,{"lat":178,"lon":177},{"type":181,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659222","phase-2-treatment-of-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma-with-pirtobrutinib-in-combination-with-epcoritamab-if-the-disease-comes-back-after-previous-treatment-100659222",false,"NCT07860775","Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With Pirtobrutinib in Combination With Epcoritamab if the Disease Comes Back After Previous Treatment.","Prospective Phase II Trial of Pirtobrutinib Treatment (24 Cycles) With 12 Cycles of Epcoritamab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. ODYSSEUS Study (Outcome-Driven Trial for Relapsed CLL\u002FSLL Combining BTK and Bispecific antibodY to Improve Outcome)","HOVON 180 CLL","In order to be eligible to participate in this study, a patient must meet all of the following criteria:\n\n* Documented relapsed or refractory CLL or SLL (SLL in Cohort Expansion only) following at least one systemic 1st-line treatment\n* Requiring treatment according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria;\n* Age at least 18 years;\n* Eastern Cooperative Oncology Group (ECOG)\u002FWorld Health Organization (WHO) performance status 0-2;\n* Adequate BM function defined as:\n\n  * Hemoglobin (Hb) \\>5 mmol\u002Fl or \\>8 g\u002FdL.\n  * Absolute neutrophil count (ANC) \\>1.0 x 109\u002FL (1,000\u002FμL)\n  * Platelet count \\>30 x 109\u002FL (30,000\u002FμL); Please note: If the patient is cytopenic there should be no evidence of myelodysplasia or hypoplastic bone marrow.\n* Estimated Glomerular Filtration Rate (eGFR) Modification of Diet in Renal Disease (MDRD) or estimated creatinine clearance (CrCl) ≥ 45 ml\u002Fmin (Cockcroft-Gault);\n* Adequate liver function as indicated:\n\n  * Serum aspartate transaminase (AS(A)T) and alanine transaminase (AL(A)T) ≤ 3.0 x upper limit of normal (ULN);\n  * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or controlled autoimmune hemolytic anemia);\n* Prothrombin time (PT)\u002FInternational normal ratio (INR) \\\u003C1.5x ULN and activated partial thromboplastin time (aPTT) \\\u003C1.5 x ULN;\n* Patients must have negative serological testing for hepatitis B and C, defined as negative hepatitis B surface antigen (HBsAg) and negative hepatitis B core antibody (anti-HBc), as well as negative hepatitis C antibody.\n\n  * Participants who are hepatitis B core antibody (anti-HBc) positive and HBsAg negative, or who are hepatitis C antibody positive, may be eligible if hepatitis B deoxyribonucleic acid (HBV-DNA) or hepatitis C ribonucleic acid (HCV-RNA) polymerase chain reaction (PCR), respectively, is negative within 6 weeks prior to enrolment. Participants with a positive HBV-DNA or HCV-RNA PCR will be excluded.\n\nPlease note:\n\nPatients who are anti-HBc positive, HBsAg negative, and HBV-DNA negative and will be treated with pirtobrutinib in combination with a B-cell-depleting agent (e.g., rituximab, obinutuzumab or epcoritamab) must receive prophylactic antiviral therapy with a nucleos(t)ide analogue (e.g., entecavir or tenofovir), starting prior to treatment initiation and continuing for 6-12 months after completion of study treatment.\n\n* For patients who are anti-HBc positive or hepatitis C antibody positive, HBV-DNA or HCV-RNA PCR, respectively, must be monitored every 1 to 3 months during study treatment and for at least 6 months after the last dose.\n* If HBV-DNA becomes detectable during study treatment, it is recommended to initiate antiviral therapy (e.g., entecavir or tenofovir) and to discontinue pirtobrutinib.\n\n  * Patient is able and willing to adhere to the study visit schedule and other protocol requirements;\n  * Patient is capable of giving informed consent;\n  * Written informed consent.\n\nA patient who meets any of the following criteria cannot be included in this study:\n\n♦ The patient has received any of the following anticancer therapies:\n\no Targeted therapies, investigational agents, therapeutic monoclonal antibodies, or cytotoxic chemotherapy within either: 5 drug half-lives, or 2 weeks prior to the first dose of study treatment, whichever is shorter.\n\nException: Anti-CD20 monoclonal antibodies, covalent BTK inhibitors, and BCL2 inhibitors are permitted and may be continued up to the first dose of pirtobrutinib.\n\n* Immunoconjugated antibody treatment within 10 weeks or 5 half-lives, whichever is shorter\n* Broad field radiation (≥ 30% of the bone marrow or whole brain radiotherapy) within 14 days\n* Palliative limited field radiation within 7 days\n* Prior treatment with a CD3 × CD20 bispecific antibody\n* Prior treatment with pirtobrutinib within 24 months\n* CAR-T-cell therapy within 100 days prior to first dose of study drug or need of anti-cytokine therapy for toxicity from CAR-T therapy and\u002For residual symptoms of neurotoxicity \\> Grade 1 from CAR-T therapy\n\n  * Transformation of CLL (Richter's transformation);\n  * Known central nervous system involvement\n  * Prior allogeneic stem cell transplantation and\u002For solid organ transplantation;\n  * Patient with a history of confirmed progressive multifocal leukoencephalopathy (PML);\n  * Current autoimmune disease-requiring immunosuppressive therapy except for up to 20 mg daily prednisone or equivalent.\n  * Current seizure disorder requiring therapy\n  * Active tuberculose (TB) or history of completed treatment for active TB within the past 12 months.\n  * Patient receiving anti-coagulation therapy (e.g. warfarin, vitamin K antagonists, phenprocoumon).\n\nPlease note: Patients being treated with direct oral anticoagulants (DOACs) can be included, but must be properly informed about the potential risk of bleeding under treatment;\n\n* Malignancies other than CLL\u002FSLL unless in remission defined as treated non-melanoma skin cancer or other neoplasias treated curatively ≥ 1 year ago, without signs of progression and not requiring systemic therapies (with the exception of ongoing anti-hormonal therapy);\n* Known allergy to xanthine oxidase inhibitors and\u002For rasburicase;\n* History of severe allergic or anaphylactic reactions to anti-CD20 monoclonal or bi-specific antibody therapy, or known significant allergy or intolerance to any component or excipient constituents of the study treatment (and their excipients) and\u002For other products in the same class;\n* History of bleeding diathesis;\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) within 2 weeks prior to first dose of study treatment;\n* Known active cytomegalovirus (CMV) infection;\n* Concurrent severe and\u002For uncontrolled medical condition (e.g. uncontrolled: infection, auto- immune hemolysis, immune thrombocytopenia, diabetes, hypertension, hyperthyroidism or hypothyroidism etc.);\n* Patient known to be Human Immunodeficiency Virus (HIV)-positive;\n* CTCAE grade III-IV cardiovascular disease including but not limited to:\n\nSignificant cardiovascular disease defined as:\n\n* unstable angina or acute coronary syndrome within the past 3 months prior to treatment initiation or a history of myocardial infarction within 3 months prior to treatment initiation or\n* documented Left Ventricular Ejection Fraction (LVEF) by any method of ≤ 40% in the 12 months prior to treatment initiation\n* ≥ Grade 3 New York Heart Association (NYHA) functional classification system of heart failure\n* Uncontrolled or symptomatic arrhythmias ♦ Screening 12-lead Electrocardiogram (ECG) showing a baseline QT (Q and T wave) interval as corrected by Fridericia's formula (QTcF) \\>480 msec.\n\nPlease note: this criterion does not apply to patients with a left bundle branch block.\n\n* Stroke or intracranial hemorrhage within 6 months prior to registration.\n* Severe pulmonary dysfunction (CTCAE grade III-IV);\n* Severe neurological or psychiatric disease (CTCAE grade III-IV);\n* Neuropathy \\> CTCAE grade II;\n* Patient who has difficulty with or is unable to swallow oral medication, or has significant gastrointestinal disease that would limit absorption of oral medication;\n* Vaccination with live vaccines within 28 days prior to registration;\n* Use of any other experimental drug or therapy within 28 days of registration;\n* Major surgery within 28 days prior to registration;\n* Pregnant women and nursing mothers;\n* Fertile men or women of childbearing potential (WOCBP) unless: (1) surgically sterile or ≥ 2 years after the onset of menopause; (2) willing to use a highly effective contraceptive method such as oral contraceptives, intrauterine device, sexual abstinence or combination of male condom with either cap, diaphragm, or sponge with spermicide (double barrier methods) during study treatment and for 4 months after last dose of epcoritamab and 5 weeks (women) or 3 months (men) after last dose of pirtobrutinib;\n* Patients who are planning egg donation (ova, oocytes) for the purposes of assisted reproduction or sperm donation during study treatment, until 4 months after last dose of epcoritamab and 5 weeks after last dose of pirtobrutinib for egg donation and 3 months after last dose of pirtobrutinib for sperm donation;\n* Current participation in other clinical trial and using study medication;\n* Any psychological, familial, sociological and geographical condition potentially hampering ompliance with the study protocol and follow-up schedule","ALL","18 Years",{"count":193,"type":194},70,"ESTIMATED","INTERVENTIONAL",[197],"PHASE2","The Haemato Oncology Foundation for Adults in the Netherlands (HOVON) has designed this study. Researchers (all doctors) are conducting the study at various hospitals in the Netherlands, Denmark and Sweden.\n\nThe study medicines pirtobrutinib and epcoritamab that are used in this study are made available by pharmaceutical companies Eli Lilly and AbbVie. This study is also funded by AbbVie and Eli Lilly.\n\nHOVON needs 70 participants for this study.\n\nThe purpose of this study is to find out how safe and effective the combination of pirtobrutinib tablets and subcutaneous epcoritamab is for patients with CLL whose disease has come back after previous treatment or whose disease did not respond well to the previous treatment. The goal is to suppress the CLL to such an extent that the disease does not come back for a long time.",[200],"CLL \u002F SLL",[188],"NOT_YET_RECRUITING","2026-09-30",{"date":205,"type":206},"2026-10-06","ACTUAL",{"date":208,"type":194},"2026-09-15",{"date":210,"type":194},"2032-10-15",{"name":5,"class":6},17]