[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06600659":3,"trial-entities:NCT06600659":84,"trial-summary:NCT06600659":89},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":23,"healthy_volunteers":15,"eligibility_criteria":42,"std_ages":50,"locations":54,"central_contacts":75,"overall_officials":77,"references":79,"see_also_links":80},"NCT06600659","23-006011","A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase","A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase","RECRUITING","2026-12-01","2026-02","2026-02-06","2023-11-02","Mayo Clinic","OTHER",false,"This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.","PRIMARY OBJECTIVE:\n\nI. To determine incidence of patients who develop hyperammonemia secondary to recombinant Erwinia asparaginase.\n\nII. To characterize patients at risk for hyperammonemia secondary to recombinant Erwinia asparaginase.\n\nOUTLINE: This is an observational study.\n\nPatients undergo blood sample collection, complete surveys, and have their medical records reviewed on study.",[19,20],"Hematopoietic and Lymphatic System Neoplasm","Acute Lymphobkastic Leukemia",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},10,"ESTIMATED",[29],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Non-Interventional Study","Non-interventional study",[33],"Observational",[35],{"measure":36,"description":37,"timeFrame":38},"Incidence of patients who develop hyperammonemia","Assessed by measuring ammonia levels via blood test. Baseline ammonia level will be determined around the time of consent. During the first two recombinant Erwinia asparaginase (Rylaze®) courses, there will be two blood draws per week. Each course of recombinant Erwinia asparaginase (Rylaze®) lasts for two weeks, so there will be four blood draws per course.","Up to 12 months",[],"ALL","1 Year",{"inclusion":43,"exclusion":46,"raw_text":49},[44,45],"Followed by pediatric hematology\u002Foncology","Receiving recombinant Erwinia asparaginase for treatment of malignancy",[47,48],"Patients \\\u003C 1 year of age","Patients who have previously received recombinant Erwinia asparaginase within the past two weeks","Inclusion Criteria:\n\n* Followed by pediatric hematology\u002Foncology\n* Receiving recombinant Erwinia asparaginase for treatment of malignancy\n\nExclusion Criteria:\n\n* Patients \\\u003C 1 year of age\n* Patients who have previously received recombinant Erwinia asparaginase within the past two weeks",[51,52,53],"CHILD","ADULT","OLDER_ADULT",[55],{"facility":56,"status":8,"city":57,"state":58,"zip":59,"country":60,"contacts":61,"geoPoint":72},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[62,67,69],{"name":63,"role":64,"phone":65,"email":66},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":68,"role":64},"Alexis Kuhn, PharmD, RPh",{"name":70,"role":71},"Catherine E. Martin, PharmD, RPh","PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},44.02163,-92.4699,[76],{"name":63,"role":64,"phone":65,"email":66},[78],{"name":70,"affiliation":56,"role":71},[],[81],{"label":82,"url":83},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":85,"biomarkers":88},[86,87],"Acute Lymphoblastic Leukemia","Hematologic Neoplasm",[],{"nct_id":4,"found":90,"summary":91,"prompt_version":101},true,{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is an observational study involving about 10 participants. It is not testing a new treatment but rather observing patients already receiving care.","completed","Observational Study of High Ammonia Levels with Recombinant Erwinia Asparaginase","This study is looking at how many patients develop high ammonia levels (hyperammonemia) after receiving a medicine called recombinant Erwinia asparaginase. This medicine is used to treat certain blood and lymphatic system cancers, like Acute Lymphoblastic Leukemia. The study will observe patients who are already receiving this treatment and are followed by a pediatric hematology\u002Foncology team. You cannot join if you are under 1 year old or have received this medicine in the last two weeks. The main goal is to see how often high ammonia levels occur within 12 months of starting the treatment. This study aims to better understand this side effect and identify who might be at risk.","Participants will be observed for the incidence of hyperammonemia for up to 12 months.",111,"You would have blood samples collected, complete surveys, and your medical records would be reviewed.","Not stated in the trial record.",[],"v2"]