[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06131801":3,"trial-entities:NCT06131801":188,"trial-summary:NCT06131801":202},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":38,"study_type":42,"primary_purpose":43,"phases":44,"enrollment_info":45,"interventions":48,"primary_outcomes":54,"secondary_outcomes":83,"sex":23,"minimum_age":84,"maximum_age":85,"healthy_volunteers":86,"eligibility_criteria":87,"std_ages":99,"locations":102,"central_contacts":178,"overall_officials":183,"references":186,"see_also_links":187},"NCT06131801","Venetoclax PK","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","RECRUITING","2027-12-01","2026-06","2026-06-04","2023-11-15","Children's Hospital Medical Center, Cincinnati","OTHER",true,"The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution","Peripheral blood will be drawn at multiple time points to evaluate venetoclax pharmacokinetics in patients who are receiving venetoclax solution made from crushed tablets as part of their oncology treatment.",[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37],"Hematologic Malignancy","Leukemia","Lymphoma","Acute Lymphocytic Leukemia","ALL","Acute Myelogenous Leukemia","AML","Chronic Myelogenous Leukemia","CML","Myeloproliferative Neoplasm","Non Hodgkin Lymphoma","Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Burkitt Lymphoma","T-cell Lymphoma","B Cell Lymphoma","Peripheral T Cell Lymphoma","Cutaneous B-Cell Lymphoma",[39,40,41],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML","OBSERVATIONAL",null,[],{"count":46,"type":47},30,"ESTIMATED",[49],{"type":14,"name":50,"description":51,"armGroupLabels":52},"1. Drug: The Venetoclax PK study is collecting bodily fluid samples (ie., whole blood and optional cerebrospinal fluid) of patients prescribed venetoclax as crushed tablets per standard of care.","Participants will receive Venetoclax as prescribed by their treating provider as part of their clinical care.",[53],"Children and Young Adults",[55,59,61,63,65,67,69,73,75,77,79,81],{"measure":56,"description":57,"timeFrame":58},"Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)","PK parameters of venetoclax will be described in peripheral blood including: the observed peak plasma concentration (Cmax)","Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.",{"measure":56,"description":60,"timeFrame":58},"PK parameters of venetoclax will be described in peripheral blood including: the time to peak (Tmax)",{"measure":56,"description":62,"timeFrame":58},"PK parameters of venetoclax will be described in peripheral blood including: the apparent terminal phase elimination rate constant (β)",{"measure":56,"description":64,"timeFrame":58},"PK parameters of venetoclax will be described in peripheral blood including: the terminal-phase elimination half-life (T1\u002F2)",{"measure":56,"description":66,"timeFrame":58},"PK parameters of venetoclax will be described in peripheral blood including: the areas under plasma concentration curve (AUC) over a 24-hour dose interval (AUC0-24) or for infinite time (AUC0-∞)",{"measure":56,"description":68,"timeFrame":58},"PK parameters of venetoclax will be described in peripheral blood including: oral clearance (CL\u002FF) of venetoclax",{"measure":70,"description":71,"timeFrame":72},"Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)","PK parameters of venetoclax will be described in cerebral spinal fluid including: the observed peak plasma concentration (Cmax)","Around Days 8, 15, 22, and\u002For 28, all +\u002F- 3 days. Not all patients will have CSF collected at these time points.",{"measure":70,"description":74,"timeFrame":72},"PK parameters of venetoclax will be described in cerebral spinal fluid including: the time to peak (Tmax)",{"measure":70,"description":76,"timeFrame":72},"PK parameters of venetoclax will be described in cerebral spinal fluid including: the apparent terminal phase elimination rate constant (β)",{"measure":70,"description":78,"timeFrame":72},"PK parameters of venetoclax will be described in cerebral spinal fluid including: the terminal-phase elimination half-life (T1\u002F2)",{"measure":70,"description":80,"timeFrame":72},"PK parameters of venetoclax will be described in cerebral spinal fluid including: the areas under plasma concentration curve (AUC) over a 24-hour dose interval (AUC0-24) or for infinite time (AUC0-∞)",{"measure":70,"description":82,"timeFrame":72},"PK parameters of venetoclax will be described in cerebral spinal fluid including: oral clearance (CL\u002FF)",[],"0 Years","38 Years",false,{"inclusion":88,"exclusion":95,"raw_text":98},[89,90,91,92,93,94],"Age: Patients must be \\\u003C39 years of age at time of study enrollment","Diagnosis: Patients may have a diagnosis of any hematologic malignancy","Central access: Patients must have an existing venous or arterial access line for PK blood draws","Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment","Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.","Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.",[96,97],"Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.","Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.",[100,101],"CHILD","ADULT",[103,120,128,144,161],{"facility":104,"status":8,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":117},"Children's Hospital Colorado","Aurora","Colorado","80045","United States",[110,115],{"name":111,"role":112,"phone":113,"email":114},"Kelly Faulk, MD","CONTACT","(720) 777-5771","Kelly.Faulk@childrenscolorado.org",{"name":111,"role":116},"PRINCIPAL_INVESTIGATOR",{"lat":118,"lon":119},39.72943,-104.83192,{"facility":121,"status":8,"city":122,"state":123,"zip":124,"country":108,"geoPoint":125},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"lat":126,"lon":127},39.12711,-84.51439,{"facility":129,"status":130,"city":131,"state":132,"zip":133,"country":108,"contacts":134,"geoPoint":141},"Children's Hospital of Philadelphia","NOT_YET_RECRUITING","Philadelphia","Pennsylvania","19104",[135,139],{"name":136,"role":112,"phone":137,"email":138},"Tasleema Patel","917-818-6971","patelt6@chop.edu",{"name":140,"role":116},"Sarah Tasian, MD",{"lat":142,"lon":143},39.95238,-75.16362,{"facility":145,"status":8,"city":146,"state":147,"zip":148,"country":108,"contacts":149,"geoPoint":158},"Texas Children's Hospital","Houston","Texas","77030",[150,154],{"name":151,"role":112,"phone":152,"email":153},"Michelle Redell, MD","(832) 822-4242","mlredell@texaschildrens.org",{"name":155,"role":112,"phone":156,"email":157},"Grace Anand","832-824-7705","gxanand@texaschildrens.org",{"lat":159,"lon":160},29.76328,-95.36327,{"facility":162,"status":8,"city":163,"state":164,"zip":165,"country":108,"contacts":166,"geoPoint":175},"Children's Hospital of Wisconsin","Milwaukee","Wisconsin","53226",[167,170,173],{"name":168,"role":112,"email":169},"Kira Mielke","kmielke@mcw.edu",{"name":171,"role":112,"email":172},"Kara Nelson","knelson@mcw.edu",{"name":174,"role":116},"Michael Burke, MD",{"lat":176,"lon":177},43.0389,-87.90647,[179],{"name":180,"role":112,"phone":181,"email":182},"Site Public Contact","(513) 636-2799","cancer@cchmc.org",[184],{"name":185,"affiliation":13,"role":116},"Lauren Pommert, MD",[],[],{"nct_id":4,"conditions":189,"biomarkers":201},[190,191,192,33,193,194,32,195,196,197,28,198,199,200],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","B-Cell Non-Hodgkin Lymphoma","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Diffuse Large B-Cell Lymphoma","Hodgkin's Granuloma","Malignant neoplasm of lymphoid, hematopoietic and\u002For related tissue","Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma","Primary cutaneous B-cell lymphoma","T-Cell Non-Hodgkin Lymphoma",[],{"nct_id":4,"found":15,"summary":203,"prompt_version":213},{"design":204,"status":205,"heading":206,"summary":207,"follow_up":208,"word_count":209,"commitments":210,"compensation":211,"drugs_mentioned":212},"This is an observational study, meaning participants will receive venetoclax as prescribed by their doctor. It aims to enroll 30 participants.","completed","Venetoclax Crushed Tablet Solution Study for Hematologic Malignancies","This study is looking at how the body handles venetoclax when it's given as a crushed tablet dissolved in liquid. This is important because some patients, especially children, can't swallow whole tablets. Researchers want to understand how much venetoclax gets into the body and how quickly it's cleared when given this way. You might be able to join if you are under 39 years old, have a blood cancer like leukemia or lymphoma, and are already receiving venetoclax as a crushed tablet solution as part of your regular care. The study will measure the amount of venetoclax in your blood at different times after you take your dose to see how it's absorbed and cleared. The study aims to enroll 30 participants, but its current status is unclear.","Not specified.",128,"You will have blood drawn at several specific times on one day between Days 5-12 after your venetoclax dose ramp-up. This includes before your dose and then 2, 5, 12, 18, and 24 hours after your dose.","Not stated in the trial record.",[],"v2"]