[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pediatric-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pediatric-acute-myeloid-leukemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100651013","tempus-open-link-for-individual-voices-in-innovative-analytics-registry-platform-protocol-for-multimodal-real-world-evidence-in-cancer-100651013",false,"NCT07756034","Tempus Open Link for Individual Voices in Innovative Analytics Registry: Platform Protocol for Multimodal Real-World Evidence in Cancer","TEMPUS ONCO-OLIVIA Registry","ONCO-OLIVIA","ONCO-OLIVIA Registry:\n\nInclusion Criteria:\n\n* Adults or children (all ages) with a pathologically confirmed diagnosis of cancer (solid tumor or hematologic malignancy) documented in the medical record; disease-specific cohorts may further define subtypes (e.g., stage, biomarker)\n* Receiving care in the United States and\u002For U.S. Territories\n* Participant (and\u002For legally authorized representative) is able and willing to provide electronic informed consent\u002Fpermission and authorization via Olivia; with re-consent at age of eighteen if applicable\n* Willing to authorize medical record retrieval under HIPAA Right of Access and\u002For TEFCA IAS\n* Access to a smartphone, tablet, or web-enabled device for remote participation (directly or via caregiver) for eConsent and optional surveys\n\nExclusion Criteria:\n\n* Not Applicable\n\nSubstudy OLV002: Pediatric Acute Myeloid Leukemia (pAML):\n\nInclusion Criteria:\n\n* Receiving or have received care in the United States and\u002For U.S. Territories\n* Participant (and\u002For legally authorized representative) is able and willing to provide electronic informed consent\u002Fpermission and authorization via the platform; with re-consent at age of eighteen if applicable\n* Legally authorized representative of participant who is deceased is able and willing to provide electronic informed consent\u002Fpermission and authorization via the platform\n* Willing to authorize medical record retrieval under HIPAA Right of Access and\u002For TEFCA IAS\n* Access to a smartphone, tablet, or web-enabled device for remote participation (directly or via caregiver) for eConsent and cohort dependent PROs\u002Fsurveys\n* Pediatric patients with a confirmed diagnosis of Acute Myeloid Leukemia (AML) including the following AML subtypes per WHO\u002FICC classification: AML with core-binding factor rearrangements (AML-CBF), AML with inv(16) (AML-NV16), acute promyelocytic leukemia (APL), AML with KMT2A rearrangement (AML-KMT2A), AML with mutated NPM1 (AML-NPM1), AML with bZIP CEBPA mutations (AML-bZIP), AML with MECOM rearrangement\n\nExclusion Criteria:\n\n\\- Suspected but unconfirmed acute myeloid leukemia",true,"ALL",{"count":20,"type":21},1000,"ESTIMATED","5 Years","OBSERVATIONAL","This study entails enrolling participants that have been diagnosed with cancer to Olivia, a commercially available AI-enabled personal health platform developed by Tempus.\n\nOlivia will serve as the primary interface for eConsent and enrollment into the registry. The platform will also help create a retrospective and prospective registry by working with over 1,000 healthcare systems to combine electronic health records (EHR) and Patient Reported Outcomes (PROs) in a single spot.\n\nThere may be sub-studies as an add-on to this parent protocol. The sub-studies will address specific goals of the targeted research activities and will usually include additional information specific to each research study.",[26,27,28,29],"Cancer","Solid Tumor Cancer","Pediatric Acute Myeloid Leukemia","Hematologic Malignancies",[31,32,33],"Registry","Olivia","De-centralized","RECRUITING","2026-08-04",{"date":37,"type":38},"2026-08-10","ACTUAL",{"date":40,"type":21},"2026-08",{"date":42,"type":21},"2031-07",{"name":44,"class":45},"Tempus AI","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":18,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":67,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":4},"100650619","phase-1-grace-a-phase-12a-study-of-vtru200-in-relapsedrefractory-aml-high-risk-mds-dlbcl-post-cart-failure-and-advanced-solid-tumors-100650619","NCT07749976","GRACE: A Phase 1\u002F2a Study of VTRU200 in Relapsed\u002FRefractory AML, High-risk MDS, DLBCL Post CART Failure and Advanced Solid Tumors","A Phase I\u002FIIa Dose Escalation and Expansion Study of VTRU200 in Adult and Pediatric Participants With Relapsed\u002FRefractory AML, HR-MDS, DLBCL Post-CART Failure and Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Adults (≥18 years) with\n\nI. Pathologically confirmed acute myeloid leukemia (AML) according to WHO 2022 criteria. Relapsed or refractory AML, defined as either:\n\n1. Refractory AML: Failure to achieve CR, CRh, or CRi after at least 2 courses of intensive induction therapy.\n2. Relapsed AML: Recurrence after prior CR, CRh, or CRi, documented by one or more of the following: Bone marrow blasts \\>5% by morphologic assessment; persistent reappearance of blasts in peripheral blood by morphologic assessment II. HR-MDS: Pathologically confirmed myelodysplastic syndrome (MDS) according to WHO 2022 criteria, with high-risk disease defined as IPSS-R high-risk or very high-risk (score \\>4.5). Ineligible for allogeneic hematopoietic stem cell transplantation.\n\nIII. DLBCL post-CAR T: histologically confirmed DLBCL per WHO 2022 criteria and relapsed or refractory disease after prior CART therapy. Qualifying post-CAR T treatment failure must be documented at least 1 month after CAR T infusion and include no metabolic response, first metabolic progressive disease, or first relapse after prior response. Prior CART infusion must have occurred at least 1 month before screening. Participants must not be in partial metabolic response or complete metabolic response at screening and must have measurable disease on PET\u002FCT (preferred) or CT\u002FMRI, defined as at least 1 nodal lesion \\>1.5 cm or at least 1 extranodal lesion \\>1.0 cm; if PET is used, lesions must be FDG-avid and consistent with active lymphoma IV. Advanced solid tumors 2. Children (6 months-11 years) and adolescents (12-17 years) with R\u002FR-AML.\n\n1. Children and adolescent refractory AML: Bone marrow contains 1% blasts by multiparametic flow cytometry (MFC) at the end of 2 cycles of induction therapy\n2. Children and adolescent relapsed AML: A single bone marrow sample showing 5% leukemic blasts by MFC, fluorescence in situ hybridization (FISH) testing or other molecular method, or a single bone marrow sample with at least two tests showing 1% blasts such as by MFC, karyotypic abnormality with at least one metaphase similar or identical to diagnosis, FISH abnormality identical to one present at diagnosis (above level of sensitivity of specific FISH probe) or polymerase chain reaction (PCR) or next generation sequencing (NGS)-based demonstration of leukemogenic lesion (e.g., fusion, mutation) identical to diagnosis and is quantifiably 1% 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky Performance Score (KPS) ≥50% 4. Adequate organ function: I. Hepatic: Serum AST\u002FALT ≤2.5×ULN and total bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's syndrome) II. Renal: Serum creatinine ≤1.5×ULN; Calculated CrCl: ≥40 mL\u002Fmin (Cockcroft-Gault \\[adults\\]; Schwartz formula \\[adolescents\\]; apply if serum creatinine is borderline) III. Cardiac: ejection fraction ≥ 50% and no evidence of pericardial effusion as determined by ECHO IV. Hematologic: WBC count must be ≤20 × 10⁹\u002FL prior to the first dose of study treatment and before each dose in Cycle 1; patients with WBC \\>20 × 10⁹\u002FL may receive cytoreduction with hydroxyurea (up to 4 g\u002Fday) and\u002For leukapheresis per protocol to achieve this threshold, with hydroxyurea held ≥12-24 hours before each study treatment dose 5. Females of childbearing potential must have a negative serum or urine pregnancy test 6. Adults: written informed consent. Adolescents: written patient assent plus parental\u002Fguardian informed consent.\n\n   7\\. Prior treatment with an investigational agent is permitted provided that at least 5 half-lives have elapsed and all treatment-related toxicities have resolved to Grade ≤1 (except alopecia). Prior T-cell engaging, checkpoint inhibitor, or cellular therapies require a minimum washout of 8 weeks.\n\n   Exclusion Criteria:\n   * 1\\. Active central nervous system (CNS) disease requiring treatment. 2. Uncontrolled or clinically significant baseline neurologic disorder (e.g., uncontrolled seizures or severe cognitive impairment\u002Fdelirium), significant psychiatric illness or active substance abuse.\n\n     3\\. Uncontrolled infections including persistent bacteremia\u002Ffungemia despite appropriate therapy, progressive invasive fungal infection, or uncontrolled viral infection with end-organ disease. Active tuberculosis.\n\n     4\\. Concurrent malignancy requiring active systemic therapy. 5. Cytotoxic chemotherapy within 14 days prior to first dose. Targeted anti-leukemic therapy within 7-14 days prior to first dose. Radiotherapy within 14 days prior to first dose (except limited-field palliative radiotherapy). Prior CD3-engaging therapy.\n\n     6\\. T-cell depleting therapy (ATG, alemtuzumab, or equivalent) within 6 months prior to enrollment 7. Severe uncontrolled cardiovascular disease (e.g., NYHA class III\u002FIV heart failure, unstable angina or MI within 6 months, uncontrolled arrhythmia). Severe uncontrolled pulmonary disease (e.g., requiring high-flow oxygen or ventilatory support).\n\n     8\\. Systemic corticosteroids \\>10 mg\u002Fday prednisone equivalent within 7 days prior to first dose.\n\n     9\\. Active autoimmune disease requiring systemic immunosuppression within the past 12 months.\n\n     10\\. Prior allogeneic transplant within 3 months or active graft-versus-host disease (GVHD).\n\n     11\\. Primary immunodeficiency (congenital immunodeficiency disorder requiring ongoing medical management).\n\n     12\\. Known HIV infection. Hepatitis B: HBsAg positive (chronic HBV infection). Hepatitis C: anti-HCV positive (HCV exposure).\n\n     13\\. Pregnant or breastfeeding 14. Known congenital or acquired bleeding disorder, including hemophilia A\u002FB or von Willebrand disease, or other clinically significant coagulopathy 15. History of severe allergic reaction to immunotherapy","6 Months",{"count":56,"type":21},108,"INTERVENTIONAL",[59,60],"PHASE1","PHASE2","About this study\n\nThis is the first study of VTRU200 in people. The main purpose of this study is to find a safe dose of VTRU200 and learn how the medicine behaves in the body. Researchers will also look for early signs that it may help treat cancer.\n\nVTRU200 is an experimental immunotherapy. It is designed to help the body's immune system find and destroy cancer cells while limiting effects on healthy cells.\n\nUnlike many cancer treatments that target a single protein, VTRU200 recognizes stress signals that are commonly found on cancer cells. These signals include certain sugars (called glycans) and fats (called phospholipids) that are present on many types of cancer cells but are uncommon on normal healthy cells. VTRU200 also attaches to immune cells called T cells and helps direct them to attack cancer cells.\n\nBecause VTRU200 targets features that are shared by many cancers, it may continue to work even if cancer cells lose or change individual proteins that other treatments depend on.\n\nWho can take part?\n\nThis study is for people with certain blood cancers that have come back after treatment or have not responded to available treatments. These include:\n\nAcute myeloid leukemia (AML) Higher-risk myelodysplastic syndromes (HR-MDS) Diffuse large B-cell lymphoma (DLBCL) that has returned after CAR T-cell therapy\n\nLater parts of the study may also include adolescents and children with AML.\n\nWhat will happen during the study?\n\nParticipants will receive VTRU200 through a vein (intravenous infusion).\n\nThe study will begin by giving small doses to help determine the safest dose for future participants. If those doses are well tolerated, later participants may receive higher doses.\n\nResearchers will:\n\nMonitor participants closely for side effects. Perform blood tests to measure how VTRU200 moves through and leaves the body. Measure how the immune system responds to treatment. Check whether the cancer shrinks, disappears, or remains under control.\n\nParticipants may receive multiple treatment cycles if they continue to benefit and do not have unacceptable side effects.\n\nWhat are the possible benefits?\n\nVTRU200 may or may not help participants. Information learned from this study may help develop new treatments for people with these cancers in the future.\n\nWhat are the possible risks?\n\nBecause VTRU200 is being tested in humans for the first time, not all side effects are known.\n\nPossible risks include reactions related to activation of the immune system, infusion-related reactions, laboratory test changes, and other side effects. Participants will be monitored closely throughout the study, and medical care will be available if side effects occur.\n\nBrief Study Description\n\nThis first-in-human, open-label, Phase 1\u002F2a study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of VTRU200 in participants with relapsed or refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndromes (HR-MDS), or diffuse large B-cell lymphoma (DLBCL) following CAR T-cell therapy. VTRU200 is an investigational trispecific T-cell engager that binds stress-associated glycans, phosphatidylserine, and CD3 to redirect T cells toward cancer cells. The Phase 1 dose-escalation portion will determine the recommended Phase 2 dose (RP2D), followed by disease-specific expansion cohorts to further evaluate safety and preliminary antitumor activity.\n\nWhy is this research important?\n\nMany blood cancers eventually stop responding to available treatments. Cancer cells can escape therapy by changing or losing the proteins that many current medicines target.\n\nVTRU200 is designed to recognize stress-related features that many cancer cells share rather than relying on a single protein target. Researchers hope this approach may reduce the chance of treatment resistance while limiting damage to healthy cells. This study will help determine whether VTRU200 can be given safely and whether it shows early signs of helping people with difficult-to-treat blood cancers.",[63,64,65,66,28],"Acute Myeloid Leukemia","Diffuse Large B Cell Lymphoma (DLBCL)","High Risk Myelodysplastic Syndrome","Solid Tumor Malignancies",[68,69],"T cell engager","TCE","NOT_YET_RECRUITING","2026-08-03",{"date":73,"type":38},"2026-08-06",{"date":75,"type":21},"2027-01",{"date":77,"type":21},"2029-01",{"name":79,"class":45},"Vitruviae",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":88,"enrollmentInfo":89,"targetDuration":91,"studyType":23,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100604527","harmonized-clinical-and-biological-database-for-integrated-research-into-the-management-of-pediatric-acute-myeloid-leukemia-100604527","NCT07150676","Harmonized Clinical and Biological Database for Integrated Research Into the Management of Pediatric Acute Myeloid Leukemia","Base de DOnnées Cliniques et Biologiques harmonisées Pour Une REcherche intégrée à la Prise en Charge Des leucémies aiguës Myéloïdes pédiatriques","DOREMy","All patients under the age of 25 diagnosed with AML in the participating centers in France.","25 Years",{"count":90,"type":21},2000,"27 Years","The aim of this project is to study the different diagnostic, predictive, and prognostic profiles, as well as their interrelationships (clinical, biological, genetic) in children with Acute Myeloid Leukemia (AML). Despite numerous research projects on separate cohorts, the prognosis for pediatric AML has not improved.\n\nThe project therefore consists of pooling research data and existing clinical and biological data from healthcare in a health data warehouse to increase its power.\n\nAs these diseases are rare and genetic subgroups even rarer, it is crucial to combine all these data sets into a single database to statistically validate our observations.\n\nThe ultimate goal of this project is to reduce the relapse rate and improve the survival rate of pediatric AML by identifying rare, uncharacterized patient subgroups at high risk of relapse, for whom clinical characteristics and outcomes will be compared with omics data, Leukemia Stem Cells signatures, and drug responses to establish accurate and in-depth profiles.",[94,28],"Acute Myeloid Leukemia (AML)","2025-08-25",{"date":97,"type":38},"2025-09-02",{"date":99,"type":21},"2025-10-01",{"date":101,"type":21},"2052-10-01",{"name":103,"class":104},"Assistance Publique - Hôpitaux de Paris","OTHER"]