[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"haematopoietic-stem-cell-transplant-allogeneic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:haematopoietic-stem-cell-transplant-allogeneic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100645078","bandicoot-an-adaptive-platform-trial-to-improve-health-outcomes-after-paediatric-stem-cell-transplant-100645078",false,"NCT07679100","BANDICOOT: An Adaptive Platform Trial to Improve Health Outcomes After Paediatric Stem Cell Transplant","BANDICOOT: An Adaptive Platform Trial Designed to Improve the Complications, Cost-effectiveness and Health Outcomes for Children Receiving a Stem Cell Transplant","BANDICOOT","Inclusion Criteria:\n\n* Aged \\>1 week to ≤ 18 years old\n* The participant is intending to receive or will be eligible for allogeneic HSCT within the next 4 months.\n\nExclusion Criteria:\n\n* Death is deemed to be imminent and inevitable AND one or more of the participant or parent\u002Fsubstitute decision maker, or attending physician are not committed to full active treatment\n* A suitable donor for HCT is not identified.\n\nEach domain may have additional, domain-specific eligibility criteria. The additional eligibility criteria that are specific to a domain will be provided in each domain-specific Study Record, linked to this Master record. Participants who fulfil the BANDICOOT Platform Eligibility Criteria will be assessed for enrolment into all domains that are active at their trial site.","ALL","1 Week","18 Years",{"count":21,"type":22},10000,"ESTIMATED","INTERVENTIONAL",[25],"NA","Background: In children with \\>120 rare diseases, haematopoietic stem cell transplant (HSCT) provides a medical \"reset\" for the body, replacing diseased or dysfunctional bone marrow with healthy donor-derived stem cells following high-dose chemotherapy and\u002For radiotherapy. However, severe and fatal complications are common with HSCT. There has been a lack of properly conducted clinical trials to decrease mortality and morbidity. Traditional randomised controlled trials (RCTs) have several critical limitations in children undergoing HSCT, including population heterogeneity, restrictive eligibility criteria and slow enrolment. Adaptive platform trials (APTs) may overcome these limitations through enhanced trial efficiency by sharing a control group, reducing sample size and allowing continuous learning from accumulating data. APTs also allow simultaneous evaluation of distinct interventions at different timepoints and in multiple subgroups of participants, facilitating tailored approaches across heterogeneous populations. When an intervention proves superior, it becomes the new standard of care, allowing additional interventions to be introduced.\n\nTo improve outcomes, we have developed an international APT - BANDICOOT. This trial will continuously enrol children and adolescents receiving HSCT and allow the assessment of multiple novel interventions simultaneously. The goal is to accelerate research findings, reduce duplication of efforts, and improve patient outcomes.\n\nObjectives: The primary objective of BANDICOOT is to determine the effectiveness of a range of interventions to improve HSCT outcomes for children and adolescents.\n\nThe secondary objectives include:\n\n* Assessing the cost-effectiveness of trial interventions\n* Assessing the safety of a range of interventions to improve HCT outcomes\n* Collection of a core data set for participants consenting to the platform regardless of domain eligibility.\n\nStudy design: BANDICOOT is a prospective, pragmatic, adaptive platform trial with interventions organised into domains. Domains may be open-label or blinded.\n\nStudy population: The trial population will be children aged 1-week old to 18 years old who are receiving an HSCT.\n\nTrial outcomes: The primary outcome is an ordinal scale of HSCT outcomes based on organ support, viraemia, immune reconstitution and relapse status censored at Day 100 post HSCT. The selection and grading of components within this ordinal endpoint was informed by a formal endpoint development process, described in detail by Walker et al, 2025 (see References).\n\nInterventions: Multiple interventions will be evaluated in BANDICOOT across multiple treatment modalities (domains). New interventions will be added over time, and interventions may be dropped for futility or included in standard care as the study progresses. The details of the interventions will be provided in separate clinicaltrials.gov Study Records, linked to this Master record.\n\nAbbreviated methods: Inferences in this trial will be based on a Bayesian statistical model. The primary outcome will be analysed using a multinomial model with a cumulative logistic link, which is an extension of a binary logistic model to account for ordinal outcomes with more than two categories, and is commonly known as the 'proportional odds' model. Secondary outcomes will be analysed with parametric models specific to the type of outcome (e.g., the Bernoulli model with a logistic link for binary endpoints).",[28],"Haematopoietic Stem Cell Transplant, Allogeneic","NOT_YET_RECRUITING","2026-06-25",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":22},"2027-03",{"date":37,"type":22},"2047-12",{"name":39,"class":40},"Murdoch Childrens Research Institute","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100630879","phase-2-asciminib--standard-of-care-integration-in-maintenance-therapy-for-post-allogeneic-stem-cell-transplant-allo-hsct-of-patient-with-ph-b-all-or-blastic-transformed-cml-100630879","NCT07493408","Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML","Efficacy and Safety of Adding Asciminib to the Standard-of-care for Post Allogenic Hematopoietic Stem-cell Transplant (HSCT) Maintenance in Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL) or Blastic Transformed CML (Myeloid or Lymphoid) (CML-BP)","ASIM-POST Ph+","Inclusion Criteria:\n\n1. The subject (or the subject's legally acceptable representative, if applicable) must be capable of giving written informed consent and, prior to the commencement of any study-specific procedure, must sign an informed consent form (ICF) indicating the consent on the subject's voluntary participation in the study and compliance with the requirements and restrictions listed on the ICF.\n2. Age ≥ 18 years\n3. Patients with Ph+ B-ALL or CML-BP, who had undergone allogeneic HSCT\n4. Patients must have received TKI therapy in induction\u002Fconsolidation therapy\n5. Absolute neutrophil count ≥ 1.0 × 109\u002FL\n6. Platelet count ≥ 50 × 109\u002FL\n\nExclusion Criteria:\n\n1. Patients with known atypical transcript that cannot be measured by available polymerase chain reaction (PCR) methods.\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2\n3. Uncontrolled hypertension\n4. Corrected QT interval (QTc) \\> 460 milliseconds for women or \\> 450 milliseconds for men\n5. Amylase and lipase values \\> 3 × upper limit of normal\n6. Patients refused standard TKI maintenance post-HSCT\n7. Unable to comply with study requirements\n8. Patients taking ponatinib as choice of TKI\n9. Patients with documented T315I mutation",{"count":50,"type":22},45,[52],"PHASE2","The goal of this clinical trial is to learn if Asciminib, a first in class allosteric inhibitor, as a add-on maintenance therapy can provides benefits and further prevents relapse in post allogenic hematopoietic stem-cell transplant (HSCT) of patients with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL) or blastic transformed Chronic Myeloid Leukemia (CML-BP).\n\nThe main questions it aims to answer are:\n\nWould Ascminib add-on maintenance therapyimprove Morphological relapse-free survival rate? Would Ascminib add-on maintenance therapy improve Molecular relapse-free survival and Overall survival ? Any toxicity or intolerable events during Ascminib add-on maintenance therapy?\n\nResearchers will compare Study arm (Ascminib plus tyrosine-kinase inhibitors \\[TKIs\\]) and Control arm (TKIs only) to see if Ascminib add-on maintenance therapy would provide better relapse-free survival (RFS) with optimal tolerability.\n\nParticipants will\n\n* Enrolled and Randomized into either Study arm or Control arm\n* Take Ascminib plus selected TKI or selected TKI only according to schedule\n* Visit the clinic once every 2-4 weeks for checkups and tests\n* Record and Report any adverse event and graft-versus-host-disease (GvHD) development",[55,56,57,28],"Ph+ Acute Lymphoblastic Leukemia (Ph+ALL)","Blastic Transformation of Chronic Myeloid Leukemia","Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL)",[59,60,61,62,63,64,65,66],"Ph+ B-ALL","CML-BP","Asciminib","Asciminib add-on","allogeneic HSCT maintenance","Asciminib with Imatinib","Asciminib with Nilotinib","Asciminib with Dasatinib","2026-03-20",{"date":69,"type":33},"2026-03-25",{"date":71,"type":22},"2026-03-30",{"date":73,"type":22},"2037-12-31",{"name":75,"class":40},"The University of Hong Kong",1]