[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612781":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":36,"responsibleParty":53,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":69,"studyType":70,"phases":10,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Hospital General de Mexico","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Frail ALL patients by ECOG >1 or KPS \u003C80%, or with severe toxicity from induction therapy",null,"Patients newly diagnosed with acute lymphoblastic leukemia (ALL) who are considered clinically frail based on an ECOG performance status score greater than 1 or a Karnofsky score below 80%, indicating a high risk of severe chemotherapy-related toxicity. This group also includes patients who have previously received induction therapy and experienced severe, limiting toxicity that prevents continuation of intensive treatment regimens. These criteria identify a vulnerable population for whom standard chemotherapy may not be suitable, necessitating alternative, less intensive treatment approaches to reduce toxicity while maintaining therapeutic efficacy",[13],"Drug: Patients meeting criteria will receive DA-EPOCH via central line for 5 days every 21 days, with monitoring, supportive care, transfusions, prophylaxis, and G-CSF for 5 doses per cycle",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Patients meeting criteria will receive DA-EPOCH via central line for 5 days every 21 days, with monitoring, supportive care, transfusions, prophylaxis, and G-CSF for 5 doses per cycle","After patient selection and confirmation of inclusion criteria, the DA-EPOCH treatment regimen will be initiated. It is typically administered through a central line over 5 days, during which adverse events will be closely monitored. Each treatment cycle lasts 21 days. All patients will receive the same level of care as those undergoing high-intensity chemotherapy, including monitoring of transfusion needs, supportive care with prophylactic medications, and the administration of colony-stimulating factors, with a total of 5 doses per cycle. The treatment regimen consists of six cycles, during which intrathecal chemotherapy will be administered to prevent central nervous system relapse. This prophylaxis will be given between each cycle. After completing the six cycles, patients will continue with a maintenance regimen consisting of 6-mercaptopurine at 50 mg\u002Fm² of body surface area from Monday to Friday, along with weekly intramuscular methotrexate (50 mg), total duration for 2 years",[9],[21],{"name":22,"affiliation":23,"role":24},"Christian O Ramos, MD","Hospital General de México Dr. Eduardo Liceaga","PRINCIPAL_INVESTIGATOR",[26,31],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","5523351588","+52","leukemiachop33@gmail.com",{"name":32,"role":27,"phone":33,"phoneExt":34,"email":35},"Ernesto Villagran, MD","7771358561","52","nerev16@gmail.com",[37],{"facility":23,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"RECRUITING","Mexico City","06720","Mexico","MX",{"type":44,"coordinates":45},"Point",[46,47],-99.12766,19.42847,{"lat":47,"lon":46},[50],{"name":22,"role":27,"phone":51,"phoneExt":34,"email":52},"55 2789 2000","enre16@hotmail.com",{"type":24,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":23,"oldNameTitle":10,"oldOrganization":10},"Christian Omar Ramos-Peñafiel, MD, PhD","Medical Doctor, Principal Investigator, Clinical Professor","100612781","efficacy-of-dose-adjusted-regimen-on-survival-in-frail-adults-with-acute-lymphoblastic-leukemia-100612781",false,"NCT07258043","Efficacy of Dose-Adjusted Regimen on Survival in Frail Adults With Acute Lymphoblastic Leukemia","Efficacy on Progression Free Overall Survival of a Dose-Adjusted Regimen in Frail Adult Patients With Acute Lymphoblastic Leukemia","EPOCH","Inclusion Criteria:\n\n* Diagnosed with acute lymphoblastic leukemia (ALL) according to the World Health Organization (WHO) criteria\n* Older than 18 years old\n* ECOG Performance Status Scale \\>1 or the Karnofsky Performance Status (KPS) \\\u003C80%.\n* Comorbidities: diabetes mellitus, arterial hypertension, thrombotic events, endocrine disorders, or any condition that hinders the administration of full-dose chemotherapy.\n* Toxicity prior to a standard chemotherapy regimen.\n* Both genders\n* Over 18 years of age\n* No upper age limit\n* Signed informed consent\n\nExclusion Criteria:\n\n´- Patients refractory to induction treatment\n\n* Patients who have previously received a low-intensity regimen due to comorbidities\n* Biphenotypic leukemia\n* CNS involvement at diagnosis requiring radiotherapy\n* Patients whose survival is expected to be less than 48 hours due to leukemiarelated complications\n* Patients with a history of ischemic or hemorrhagic stroke or severe neurological deterioration\n* Pregnant patients","ALL","18 Years",{"count":67,"type":68},45,"ESTIMATED","1 Year","OBSERVATIONAL","Acute lymphoblastic leukemia (ALL) is characterized by the abnormal proliferation of immature precursor cells, disrupting normal hematopoiesis and causing severe anemia and thrombocytopenia due to genetic mutations. Conventional treatment with intensive chemotherapy is limited for elderly patients or those with comorbidities, adversely affecting their survival. In Mexico, alongside a higher incidence, treatment-related complications are more frequent, particularly with drugs such as asparaginase or anthracyclines, which limits therapeutic efficacy. The transition to infusion-based therapies promises to reduce these complications, improve treatment tolerance, and optimize clinical outcomes, marking a significant advancement in the management of this disease. Modifying treatment regimens toward infusion therapies has the potential to significantly reduce adverse complications, enhance treatment tolerance, and ultimately improve clinical outcomes for patients who cannot benefit from conventional intensive regimens. This approach not only aims to optimize treatment effectiveness but also to minimize associated risks, thus representing an important advancement in the management of acute lymphoblastic leukemia in clinical settings such as those in Mexico",[73,74,75],"Acute Lymphobkastic Leukemia","Leukemia","Overall Survival",[77,62],"acute lymphoblastic leukemia","2025-11-26",{"date":80,"type":81},"2025-12-02","ACTUAL",{"date":83,"type":81},"2025-07-23",{"date":85,"type":68},"2026-07-26",{"name":5,"class":6},1]