[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03680677":3,"trial-entities:NCT03680677":86,"trial-summary:NCT03680677":92},{"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":17,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":44,"secondary_outcomes":49,"sex":54,"minimum_age":55,"maximum_age":17,"healthy_volunteers":56,"eligibility_criteria":57,"std_ages":61,"locations":64,"central_contacts":74,"overall_officials":80,"references":84,"see_also_links":85},"NCT03680677","UPCC 06718","Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies","Prospective Analysis of Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies","RECRUITING","2027-11","2026-08","2026-08-12","2018-09-21","Abramson Cancer Center at Penn Medicine","OTHER",true,"The purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant.",null,[19,20],"Leukemia, Acute","MDS",[],"OBSERVATIONAL",[],{"count":25,"type":26},20,"ESTIMATED",[28,34,39],{"type":29,"name":30,"description":31,"armGroupLabels":32},"PROCEDURE","Bone Marrow or Peripheral Blood Graft (BMT)","Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.",[33],"Transplant",{"type":14,"name":35,"description":36,"armGroupLabels":37},"Cancer-directed Therapy or Best Supportive Care","Cancer-directed therapy with intensive regimens (\"7+3,\" Vyxeos, clofarabine, or similar), clinical trial, hypomethylating agent (azacitidine or decitabine), hypomethylating agent combinations (i.e. with venetoclax, sorafenib, enasidenib, ivosidenib, midostaurin, gilteritinib, or other targeted agent), targeted agents alone (i.e. enasidenib, ivosidenib, gilteritinib, midostaurin, etc.), or supportive care.",[38],"Cancer Directed Therapy or Best Supportive Care",{"type":40,"name":41,"description":42,"armGroupLabels":43},"DIAGNOSTIC_TEST","Frailty Assessment","Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.",[38,33],[45],{"measure":46,"description":47,"timeFrame":48},"Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients","NRM will be defined as death without evidence of disease progression or relapse.","1-month",[50],{"measure":51,"description":52,"timeFrame":53},"NRM by Intensity of Treatment","NRM of frail and pre-frail patients by intensity of treatment","1-month and 6-month","ALL","60 Years",false,{"inclusion":58,"exclusion":59,"raw_text":60},[],[],"Eligibility Criteria Arm A:\n\n* Age 60 years or older.\n* New diagnosis of Acute Leukemia or MDS, or suspected diagnosis.\n* Able to consent to the study.\n\nEligibility Criteria Arm B:\n\n* Age 60 years or older with a hematologic malignancy.\n* Plan to undergo an allogeneic blood or marrow transplantation or CAR T-cell therapy.\n* Able to consent to the study.",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"Abramson Cancer Center of the University of Pennsylvania","Philadelphia","Pennsylvania","19104","United States",{"lat":72,"lon":73},39.95238,-75.16362,[75],{"name":76,"role":77,"phone":78,"email":79},"Shannon McCurdy, MD","CONTACT","855-216-0098","penncancertrials@emergingmed.com",[81],{"name":76,"affiliation":82,"role":83},"Abramson Cancer Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":87,"biomarkers":91},[88,89,90],"Acute Leukemia","Hematologic Neoplasm","Myelodysplastic Syndrome",[],{"nct_id":4,"found":15,"summary":93,"prompt_version":103},{"design":94,"status":95,"heading":96,"summary":97,"follow_up":98,"word_count":99,"commitments":100,"compensation":101,"drugs_mentioned":102},"This is an observational study, meaning researchers will watch and collect information without assigning specific treatments. It plans to include 20 participants.","completed","Frailty Assessments for Older Patients with Blood Cancers","This observational study is looking at how frailty assessments can help predict outcomes for people aged 60 and older with acute leukemia or myelodysplastic syndromes (MDS). Researchers want to see if these assessments can tell how well patients will do after treatments like chemotherapy (e.g., \"7+3,\" Vyxeos, clofarabine), CAR T-cell therapy (a type of immunotherapy), or allogeneic stem cell transplant (BMT). The study aims to understand if being frail, pre-frail, or not frail affects the risk of non-relapse mortality (death not caused by the cancer returning) one month after treatment. The study plans to enroll 20 participants, but its current status is unclear.","The primary outcome, non-relapse mortality, is measured at 1-month.",103,"Not specified in the trial record.","Not stated in the trial record.",[41],"v2"]