[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07008027":3,"trial-entities:NCT07008027":94,"trial-summary:NCT07008027":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":32,"secondary_outcomes":49,"sex":50,"minimum_age":26,"maximum_age":26,"healthy_volunteers":14,"eligibility_criteria":51,"std_ages":61,"locations":65,"central_contacts":83,"overall_officials":85,"references":87,"see_also_links":88},"NCT07008027","REWASPY","Real World Asparaginase Therapy Toxicity","NOT_YET_RECRUITING","2031-07","2026-08","2026-08-13","2026-09","St. Jude Children's Research Hospital","OTHER",false,"This research study is being done to learn more about the short term and long term side effects of treatment with asparaginase drugs, which are commonly used in acute lymphoblastic leukemia (ALL) or acute lymphoblastic lymphoma (LLy) therapy.","Primary Objective\n\n* To estimate the rate of high-grade toxicities which occur during therapy for acute lymphoblastic leukemia\u002F lymphoma in patients receiving asparaginase-containing standard of care therapy.\n\nThis study will involve the collection of data about the participants ALL\u002FLLy, treatment, side effects of treatment and leukemia\u002F lymphoma's response to treatment. Data collected on other research studies participants are enrolled on will also be used for this research study.\n\nBlood samples will be collected and liver fibroscans (liver ultrasounds) will be done at different time points while the participant is receiving treatment for ALL\u002FLLy. The time points will depend on what treatment they receive and will correspond to days on their treatment roadmap.",[18],"Drug Toxicity",[20,21,22,23,24],"Asparaginase drugs","Toxicity","Acute lymphoblastic leukemia","Acute lymphoblastic lymphoma","Mixed phenotype acute leukemia","OBSERVATIONAL",null,[],{"count":29,"type":30},200,"ESTIMATED",[],[33,37,39,42,44,47],{"measure":34,"description":35,"timeFrame":36},"Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities during standard of care (SOC) therapy","The overall probability of on-therapy grade 3+ or 4+ toxicity will be estimated by the sample proportion along with the Normal approximation (Z-statistic) based 95% confidence interval.","Approximately 2½ to 3 years",{"measure":38,"description":35,"timeFrame":36},"Probability of developing CTCAE grade 3+ (3, 4, 5) or 4+ (4, 5) toxicities SJALL23T therapy",{"measure":40,"description":41,"timeFrame":36},"Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SOC therapy","Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout therapy will be estimated using the Kalbafleisch-Prentice method.",{"measure":43,"description":41,"timeFrame":36},"Cumulative incidence (CIN) of the grade 3+ or 4+ toxicities throughout SJALL23T therapy",{"measure":45,"description":46,"timeFrame":36},"Probabilities of grade 3+ or 4+ toxicities each phase of SOC treatment","Probabilities of grade 3+ or 4+ toxicities will be estimated for each treatment phase by sample proportions accompanied by the Z-statistic 95% confidence intervals.",{"measure":48,"description":46,"timeFrame":36},"Probabilities of grade 3+ or 4+ toxicities each phase of SJALL23Ttreatment",[],"ALL",{"inclusion":52,"exclusion":58,"raw_text":60},[53,54,55,56,57],"Diagnosis of acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia","Enrolled on INITIALL and no more than 10 days after initiation of post-INITIALL therapy","Post-INITIALL therapy is:","Standard of Care (SOC)\u002FNon Protocol Treatment Plan (NPTP) as per Total therapy or","SJALL23T and not scheduled to receive venetoclax",[59],"Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.","Inclusion Criteria:\n\n* Diagnosis of acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia\n* Enrolled on INITIALL and no more than 10 days after initiation of post-INITIALL therapy\n* Post-INITIALL therapy is:\n\n  * Standard of Care (SOC)\u002FNon Protocol Treatment Plan (NPTP) as per Total therapy or\n  * SJALL23T and not scheduled to receive venetoclax\n\nExclusion Criteria:\n\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.",[62,63,64],"CHILD","ADULT","OLDER_ADULT",[66],{"facility":12,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":80},"Memphis","Tennessee","38105","United States",[72,77],{"name":73,"role":74,"phone":75,"email":76},"Seth E. Karol","CONTACT","888-226-4343","referralinfo@stjude.org",{"name":78,"role":79},"Seth E. Karol, MD, MSCI","PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},35.14953,-90.04898,[84],{"name":78,"role":74,"phone":75,"email":76},[86],{"name":78,"affiliation":12,"role":79},[],[89,91],{"label":12,"url":90},"http:\u002F\u002Fwww.stjude.org",{"label":92,"url":93},"Clinical Trials Open at St. Jude","http:\u002F\u002Fwww.stjude.org\u002Fprotocols",{"nct_id":4,"conditions":95,"biomarkers":99},[96,97,98],"Acute Lymphoblastic Leukemia","Lymphoblastic Lymphoma","Mixed Phenotype Acute Leukemia",[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an observational study with a planned enrollment of 200 participants. It is not specified if it is randomized or blinded.","completed","Real World Asparaginase Therapy Toxicity Study","This study aims to understand the short-term and long-term side effects of asparaginase drugs, which are commonly used to treat acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LLy). Researchers want to see how often patients develop serious side effects (called CTCAE grade 3+ or 4+ toxicities) while receiving standard care therapy or SJALL23T therapy. You may be able to join if you have been diagnosed with ALL, LLy, or mixed phenotype acute leukemia, and are enrolled in the INITIALL study or have recently started post-INITIALL therapy. The study will look at how many people experience these side effects over approximately 2½ to 3 years.","The primary endpoints for this study are measured at approximately 2½ to 3 years, indicating a follow-up period of that length.",104,"This study involves collecting data about your ALL\u002FLLy, treatment, side effects, and how your leukemia\u002Flymphoma responds to treatment. Blood samples and liver fibroscans (liver ultrasounds) will be taken at different times during your ALL\u002FLLy treatment.","Not stated in the trial record.",[],"v2"]