[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07250087":3,"trial-entities:NCT07250087":132,"trial-summary:NCT07250087":137},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":36,"secondary_outcomes":41,"sex":49,"minimum_age":50,"maximum_age":17,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":66,"locations":69,"central_contacts":122,"overall_officials":128,"references":130,"see_also_links":131},"NCT07250087","MCC-23477","Asciminib Maintenance Therapy Following alloHCT or CAR T to Prevent Relapse in Adults With Ph+ALL","Phase 1 Study of Asciminib Maintenance Therapy Following Allogeneic Stem Cell Transplant or Chimeric Antigen Receptor T Cell Therapy (CAR T) to Prevent Relapse in Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia","RECRUITING","2029-11","2026-03","2026-03-27","2026-01-21","H. Lee Moffitt Cancer Center and Research Institute","OTHER",true,"The purpose of the study is to see if a study drug called asciminib is safe and okay for people to take after they've had treatment for a type of blood cancer called Philadelphia Chromosome\n\nPositive Acute Lymphoblastic Leukemia (Ph+ B-ALL). We're looking at two groups of adults:\n\none group had an Allogeneic Stem Cell Transplant (alloHCT) cohort A, and the other group had chimeric antigen receptor T cell (CAR T) therapy, cohort B. We also want to figure out what the best dose of asciminib is to use moving forward in future studies.",null,[19],"Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},36,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Asciminib","Treatment will be administered on an outpatient basis.",[34,35],"Patients post-CAR T cell therapy","Patients post-alloHCT",[37],{"measure":38,"description":39,"timeFrame":40},"Recommended Phase 2 Dose","The MTD is defined as the highest dose level at which one or none of six patients experience a DLT.","Up to 24 months",[42,46],{"measure":43,"description":44,"timeFrame":45},"Relapse-free survival (RFS)","Relapse-free survival (RFS) is defined as the time from starting asciminib to the date of relapse or death, whichever comes first.","Up to 24 Months",{"measure":47,"description":48,"timeFrame":45},"Overall survival (OS)","Overall survival (OS) is defined as the time from starting asciminib to the date of death.","ALL","18 Years",false,{"inclusion":53,"exclusion":59,"raw_text":65},[54,55,56,57,58],"Age ≥18 years","Diagnosis of Ph+ B-ALL with detectable Philadelphia chromosome abnormalities","Morphologic remission (\\\u003C5% marrow blasts)","ECOG performance status 0-2","Adequate organ function",[60,61,62,63,64],"Active relapsed disease (\\>5% blasts)","Grade II-IV acute GVHD requiring systemic steroids","Significant organ dysfunction or uncontrolled infection","Pregnancy or breastfeeding","Prior investigational CAR T product","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of Ph+ B-ALL with detectable Philadelphia chromosome abnormalities\n* Morphologic remission (\\\u003C5% marrow blasts)\n* ECOG performance status 0-2\n* Adequate organ function\n\nExclusion Criteria:\n\n* Active relapsed disease (\\>5% blasts)\n* Grade II-IV acute GVHD requiring systemic steroids\n* Significant organ dysfunction or uncontrolled infection\n* Pregnancy or breastfeeding\n* Prior investigational CAR T product",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":119},"Moffitt Cancer Center","Tampa","Florida","33612","United States",[77,80,83,85,87,89,91,93,95,97,99,101,103,105,107,109,111,113,115,117],{"name":78,"role":79},"Rawan Faramand, MD","PRINCIPAL_INVESTIGATOR",{"name":81,"role":82},"Melissa Alsina, MD","SUB_INVESTIGATOR",{"name":84,"role":82},"Nelli Bejanyan, MD",{"name":86,"role":82},"Omar Castaneda Puglianini, MD",{"name":88,"role":82},"Ciara Freeman, MD",{"name":90,"role":82},"Doris Hansen, MD",{"name":92,"role":82},"Michael Jain, MD",{"name":94,"role":82},"Farhad Khimani, MD",{"name":96,"role":82},"Aleksandr Lazaryan, MD",{"name":98,"role":82},"Hien Liu, MD",{"name":100,"role":82},"Frederick Locke, MD",{"name":102,"role":82},"Asmita Mishra, MD",{"name":104,"role":82},"Taiga Nishihori, MD",{"name":106,"role":82},"Lia Perez, MD",{"name":108,"role":82},"Sayeef Mirza, MD",{"name":110,"role":82},"Fabiana Perna, MD",{"name":112,"role":82},"Joseph Pidala, MD",{"name":114,"role":82},"Reshma Ramlal, MD",{"name":116,"role":82},"Nancy Torres Luna, MD",{"name":118,"role":82},"Bijal Shah, MD",{"lat":120,"lon":121},27.94752,-82.45843,[123],{"name":124,"role":125,"phone":126,"email":127},"Valerie Trujillo","CONTACT","813-745-3178","Valerie.Trujillo@moffitt.org",[129],{"name":78,"affiliation":71,"role":79},[],[],{"nct_id":4,"conditions":133,"biomarkers":135},[134],"B Acute Lymphoblastic Leukemia with t(9;22)(q34.1;q11.2); BCR-ABL1",[136],"BCR\u002FABL1 Fusion Gene",{"nct_id":4,"found":15,"summary":138,"prompt_version":148},{"design":139,"status":140,"heading":141,"summary":142,"follow_up":143,"word_count":144,"commitments":145,"compensation":146,"drugs_mentioned":147},"This is an interventional study, meaning participants will receive a specific treatment. The study aims to determine the recommended Phase 2 dose of asciminib.","completed","Asciminib After Transplant or CAR T for Ph+ ALL","This study is looking at whether a drug called asciminib is safe and effective for adults with Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ B-ALL) to take after they've had either an allogeneic stem cell transplant (alloHCT) or CAR T-cell therapy. The main goal is to find the best dose of asciminib to use in future studies. You might be able to join if you are at least 18 years old, have Ph+ B-ALL in remission (meaning less than 5% cancer cells in your bone marrow), and meet other health requirements. The study plans to include 36 participants.","The primary endpoint will be measured for up to 24 months after treatment.",98,"Treatment with asciminib will be given on an outpatient basis. The primary endpoint, which is about the recommended dose, will be measured for up to 24 months.","Not stated in the trial record.",[31],"v2"]