[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CareDx\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100638161","forecasting-relapse-outcomes-with-alloheme-based-risk-detection-in-post-allo-hct-amlmds-patients-forward-100638161",false,"NCT07607327","Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML\u002FMDS Patients (FORWARD)","Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML\u002FMDS Patients (FORWARD): A Multicenter, Prospective Observational Cohort Study in US Transplant Centers","FORWARD","Inclusion Criteria:\n\n1. Adults aged 18 years or above.\n2. The participant must have one of the following diseases: AML or MDS (including CMML) and be eligible for allogeneic hematopoietic stem cell transplant. For participants with active disease (\\> 5% blasts) before HCT, the treating physician must have the intent to perform a bone marrow examination at day 30 post-HCT as SOC patient management to confirm complete remission (\\\u003C5% blasts).\n3. Participant must receive an allo-HCT from an HLA-matched related or unrelated donor, an HLA-mismatched donor, or a haploidentical donor.\n4. Participant can be enrolled before, at, or up to 1-month post-allo-HCT as long as the participant is in complete remission (CR) at Day 30 and that a recipient pre-transplant or donor sample is available for baseline genotyping (reference). If the reference sample is unavailable or fails testing, the buccal swab collected at Day 30 may be used as the reference sample.\n5. Myeloablative or reduced intensity\u002Fnon-myeloablative conditioning except T-cell depleting therapies (Ex-vivo T cell depletion, CD34 selected graft, use of anti-thymocyte globulin or alemtuzumab).\n6. Any graft versus host disease (GVHD) prophylaxis regimen.\n7. Willing and able to provide written informed consent.\n8. Willing and able to comply with study visits and procedures, including scheduled sample collections and clinical assessments\n\nExclusion Criteria:\n\n1. History of prior allo-HCT or any prior solid organ transplant.\n2. Syngeneic donor (identical twin).\n3. T cell depleted transplant (Ex-vivo T cell depletion, CD34 selected graft, use of antithymocyte globulin or alemtuzumab in the conditioning regimen)\n4. Cord blood graft.\n5. Pregnancy\n6. Any condition that, in the investigator's opinion, would interfere with the participant's ability to comply with study procedures or jeopardize their safety.\n7. Concurrent participation in an interventional or maintenance clinical trial for post allo-HCT relapse prevention; co-enrollment with other trials, such as those intended for GVHD \u002F infection prevention or improving supportive care, is allowed.","ALL","18 Years",{"count":20,"type":21},400,"ESTIMATED","OBSERVATIONAL","AlloHeme is a blood-based monitoring test developed by the CareDx laboratory that utilizes NGS technology coupled with a proprietary algorithm to predict the likelihood of a relapse in post-allo-HCT AML\u002FMDS patients. The technology analyzes 405 single nucleotide polymorphisms (SNPs) selected from across all somatic chromosomes between the donor and the recipient. Pre-transplant DNA is obtained from donor and\u002For recipient to identify specific donor and recipient SNPs (baseline samples). Post-transplant blood samples are obtained and compared to the baseline sample profiles to precisely calculate the percentage chimerism of recipient cells in the blood samples using a proprietary quantitative method and unique dual indexing that optimizes recipient DNA at trace levels. This approach enables highly accurate and reproducible chimerism measurement with a limit of detection down to 0.02%. The AlloHeme test leverages a proprietary algorithm that integrates this multi-analyte longitudinal chimerism data with post-transplant time points to predict the likelihood of a clinical relapse for AML\u002FMDS patients following an allo-HCT.",[25,26,27],"AML (Acute Myelogenous Leukemia)","MDS (Myelodysplastic Syndrome)","CMML",[29,30],"Chimerism","Relapse","NOT_YET_RECRUITING","2026-05-19",{"date":34,"type":35},"2026-05-26","ACTUAL",{"date":37,"type":21},"2026-08-31",{"date":39,"type":21},"2030-08-31",{"name":41,"class":42},"CareDx","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100474536","heartcare-immuno-optimization-in-cardiac-allografts-mosaic-100474536","NCT05459181","HeartCare Immuno-optimization in Cardiac Allografts (MOSAIC)","Molecular Outcome Surveillance Using AlloSure and AlloMap Guided Immunomodulation in Cardiac Transplant","MOSAIC","Inclusion Criteria:\n\n1. Heart transplant recipients \\\u003C2 weeks post-transplant\n2. Patients aged 18 years or older\n3. Planned post-transplant maintenance immunosuppression regimen consisting of prednisolone, tacrolimus and mycophenolate\n4. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter\n5. Participant is willing and able to give informed consent for participation in the trial\n6. In the Investigator's opinion, is able and willing to comply with all trial requirements\n\nExclusion Criteria:\n\nThe participant may not enter the trial if ANY of the following apply:\n\n1. Multi-visceral transplant recipients\n2. Female participant who is pregnant, lactating or planning pregnancy during the trial\n3. Heart transplant recipients undergoing desensitization protocols prior to transplant based off high immunological risk profiles (determined by treating clinician)\n4. Chronic oral steroid use for any reason that cannot be tapered off and discontinued\n5. Planned post-transplant immunosuppression regimen utilizing cyclosporine, azathioprine, mTOR inhibitors, and\u002For co-stimulatory blockers\n6. Contraindication to having AlloSure or AlloMap testing\n7. Participant with life expectancy of less than 6 months or is inappropriate for immuno-optimization (including those patients at increased risk of primary disease recurrence w\u002F reduction in post-transplant immunosuppression)\n8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. This includes clinical events that would significantly impact post-transplant immunosuppression such as major infectious complications or significant rejection episodes within the first month post-transplant.\n9. Participants who are currently or have previously participated in another research trial involving an investigational immunological drug in the past 12 weeks\n10. Any condition that would preclude protocol biopsies\n\nRandomization Criteria (assessed at Week 4)\n\nThe participant may not proceed with randomization if ANY of the following apply at Week 4 post-transplant:\n\n1. Maintenance immunosuppression that includes cyclosporine, azathioprine, mTOR inhibitors, and\u002For co-stimulatory blockers\n2. Any episodes of biopsy-proven acute rejection (ACR ≥2R or AMR\\*)\n3. Abnormal molecular profile defined as AlloSure \\>0.2%\n4. Allograft dysfunction defined as LVEF \\\u003C45%\n5. eGFR \\\u003C30mL\u002Fmin\n6. Presence of DSA (persistence of any pre-transplant DSA or dnDSA) \\*AMR 1 (H+) with DSA\u002Fgraft dysfunction or AMR \\> 2",{"count":53,"type":21},930,"INTERVENTIONAL",[56],"NA","This is an unblinded, randomized, controlled, two-arm interventional research study enrolling patients who are undergoing heart transplantation. The aim of the study is to determine whether patients at low risk of rejection can safely reduce the doses of their post-transplant immunosuppression medications using a combination of tests that include donor-specific antibodies (DSA), histology (looking at tissue from the donor heart), donor-derived cell-free DNA (AlloSure), and gene expression profiling (AlloMap). Eligible participants will be randomized in a 1:1 ratio into the HeartCare immune-optimization (intervention) arm or the corresponding observational (control) arm. AlloSure and AlloMap are the components of the HeartCare panel developed by CareDx.",[59,60,61],"Heart Transplant","Immunosuppression","Allograft",[63,64,65,66,67,68,69,70,71,72],"HeartCare","Allograft loss and survival","Calcineurin inhibitors","Chronic immunosuppression","Steroid avoidance","Donor-specific antibodies","Donor-derived cell-free DNA","AlloSure","AlloMap","Gene expression profiling","2024-10-21",{"date":75,"type":35},"2024-10-23",{"date":77,"type":21},"2025-12",{"date":79,"type":21},"2026-09",{"name":41,"class":42},""]