[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-acute-myeloid---aml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-acute-myeloid---aml":35},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,83],{"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":38,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100632820","phase-1-phase-i-clinical-trial-of-thinkk-adoptive-immunotherapy-after-allogeneic-hematopoietic-transplantation-in-children-with-leukemia-or-neuroblastoma-100632820",false,"NCT07518654","Phase I Clinical Trial of ThINKK Adoptive Immunotherapy After Allogeneic Hematopoietic Transplantation in Children With Leukemia or Neuroblastoma","Phase I Clinical Trial of Therapeutic Inducers of Natural Killer Killing (ThINKK) Adoptive Immunotherapy: Feasibility, Safety and Pharmacodynamics in Children Undergoing Allogenic Hematopoietic Transplantation for Leukemia or Neuroblastoma","ThINKK-01","Inclusion Criteria:\n\n1. Between 2 and less than 13 years old at time of informed consent form signature.\n2. Diagnosis of acute leukemia or neuroblastoma.\n3. Allogenic hematopoietic stem cell transplantation 30 to 90 days prior to eligibility confirmation.\n4. Blood NK cell counts ≥ 100 x 10E+6 cells\u002FL at least once before eligibility confirmation.\n5. Life expectancy of ≥ 3 months per investigator's judgment at time of eligibility confirmation.\n6. Patient or legally acceptable representative has provided informed consent based on local regulations and\u002For guidelines prior to any study-specific activities\u002Fprocedures being initiated.\n\nExclusion Criteria:\n\n1. Current grade 3 or 4 acute GvHD (per MAGIC criteria).\n2. Relapse of primary malignancy, or any other active malignancy.\n\n   1. For leukemia, defined as either morphological relapse or Minimal Residual Disease (MRD) ≥0.01% as measured by flow cytometry. MRD detected by polymerase chain reaction (PCR) does not constitute an exclusion criterion.\n   2. For neuroblastoma, defined as a progressive disease.\n3. Ongoing therapy with systemic corticosteroids (equivalent to a prednisone dose \\>0.5 mg\u002Fkg\u002Fday). Patients actively undergoing corticosteroid tapering during Screening may be enrolled once they have reached a prednisone-equivalent dose ≤ 0.5 mg\u002Fkg\u002Fday with Sponsor-Investigator approval, with the expectation that the taper will continue.\n4. Ongoing systemic therapy with cyclosporine.\n5. Administration or planned administration of any prohibited treatment listed in ad hoc section.\n6. Aspartate aminotransferase and alanine aminotransferase serum levels ≥5 times the upper limit of normal.\n7. Direct bilirubin serum levels ≥3 times the ULN (unless due to Gilbert syndrome).\n8. Baseline estimated glomerular filtration rate \\\u003C 50 mL\u002Fmin\u002F1.73 m2, as determined using the Bedside Schwartz equation for \\\u003C 18 years of age.\n9. Grade 4 diarrhea (ie, life-threatening consequences with urgent intervention indicated).\n10. O2 Sat saturation \\\u003C90% on room air by pulse oximetry.\n11. Uncontrolled life-threatening symptomatic infection(s).\n12. Blood pressure below the 5th percentile for age, sex, and height last 24 hours.\n13. Ongoing therapy with intravenous vasopressor agent.\n14. Any condition that, in the opinion of the Investigator, would compromise the safety of the patient, would prevent full participation in this study, or would interfere with the evaluation of any study endpoints.\n15. Pregnancy or breastfeeding or absence of highly effective methods of contraception for males and females of childbearing potential who engage in heterosexual intercourse","ALL","2 Years","12 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A first-in-class adoptive immunotherapy we called ThINKK, for Therapeutic Inducers of Natural Killer (NK) cell Killing, have been designed for use after hematopoietic stem cell transplantation (HSCT), where the proper stimulation of graft-derived NK cells has been shown to prevent relapse.\n\nThINKK immunotherapy builds on our earlier research on NK cells and plasmacytoid dendritic cells (PDC) in cord blood and after HSCT. PDC are the sentinels of the immune system. Upon viral nucleic acids detection, PDC secrete a vast array of chemokines and cytokines that stimulate NK cells. PDC stimulation enhances NK cells killing of infected cells that express stress-induced molecules. Cancer cells also express stress-related molecules at their surface. However, NK cells do not receive PDC stimulation when fighting cancer. ThINKK therapy is designed to provide this necessary stimulation.",[28,29,30,31,32,33,34,35,36,37],"Leukaemia (Acute Lymphoblastic)","Leukaemia (Acute Myeloid)","Neuroblastoma","Neuroblastoma, Metastatic","Leukaemia, Lymphoblastic, Acute","Leukemia Acute Myeloid","Leukemia (Both ALL and AML)","Leukemia Acute Myeloid - AML","Hematopoetic Stem Cell Transplantation","Hematopoetic Stem Cell Transplant",[39,40,41,42],"Thinkk","NK cells","pdc","immunotherapy","NOT_YET_RECRUITING","2026-04-02",{"date":46,"type":47},"2026-04-08","ACTUAL",{"date":49,"type":22},"2026-05-01",{"date":51,"type":22},"2029-05-01",{"name":53,"class":54},"Michel Duval","OTHER",2,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100623144","phase-1-study-with-tocilizumab-in-combination-with-venetoclax-and-azacitidine-chemotherapy-in-patients-with-acute-myeloid-leukemia-100623144","NCT07392814","Study With Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia","Single-Center Phase 1 Study With Escalating Doses of Tocilizumab in Combination With Venetoclax and Azacitidine Chemotherapy in Patients With Acute Myeloid Leukemia (AML). TOCIVENA","TOCIVENA","Inclusion Criteria:\n\n* First-line AML regardless of karyotype and molecular profile\n* ECOG \\\u003C= 3\n* Patient eligible for chemotherapy combining azacitidine and venetoclax\n* Informed consent\n* Liver function tests: transaminases \\\u003C 3x normal, bilirubin \\\u003C 1.5x normal\n* Creatinine clearance \\> 30 ml\u002Fmin\n\nExclusion Criteria:\n\n* LAM3\n* Patients eligible for intensive \"3+7\" treatment\n* Uncontrolled infection\n* Active and\u002For treated infection with Hep B, C, or HIV\n* No social security or other health insurance\n* Pregnant women or patients who cannot use contraception due to fertility\n* Breastfeeding women\n* Minors\n* Adults under guardianship, conservatorship, or legal protection\n* Hypersensitivity to any of the active substances or excipients (see SPCs)\n* Patients unable to understand spoken or written French","18 Years",{"count":21,"type":22},[25],"This is a phase 1, open label, interventional, single center, in patients with Acute Myeloid Leukemia (AML). This study will investigate dose escalation of tocilizumab in combination with venetoclax and azacitidine chemotherapy.\n\nThe patient population will consist of adults men and women at least 18 years, who meet eligibility criteria. In this study propose combining tocilizumab with the standard treatment of azacitidine and venetoclax for patients with AML who are not eligible for intensive treatment.",[35],[70,71,72],"Leukemia","IL6","tocilizumab","2026-02-12",{"date":75,"type":47},"2026-02-17",{"date":77,"type":22},"2026-03-10",{"date":79,"type":22},"2030-07-10",{"name":81,"class":54},"Nantes University Hospital",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":64,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":23,"phases":92,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":97,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":82},"100584214","involvement-of-cda-andor-dck-metabolizing-enzymes-in-the-response-to-azacytidine-treatment-of-patients-with-hematologic-malignancies-100584214","NCT06886425","Involvement of CDA and\u002For dCK Metabolizing Enzymes in the Response to Azacytidine Treatment of Patients With Hematologic Malignancies","CDA-AML-MDS","Inclusion Criteria:\n\n* Patients over 18 years of age\n* Patients with acute myeloid leukemia\n* Patient with myelodysplastic syndrome\n* Person who has given non-opposition\n* Patient who has signed an authorization to perform a constitutional genetic analysis (in the context of care)\n* Need for effective contraception in patients of childbearing age\n\nExclusion Criteria:\n\n* Failure to obtain non-opposition\n* Adults under guardianship or safeguard of justice\n* Persons deprived of their liberty\n* Patient participating in another research project\n* Pregnancy in progress",{"count":91,"type":22},70,[93],"NA","Until now, the development of personalized medicine in oncology has relied on the use of somatic biomarkers to help therapists choose the right molecule(s) to administer, based on the genetic and molecular profile of each hematological disease. In this project, investigators propose to extend the strategy of therapeutic individualization to the field of dosage targeting. Today, azacytidine is a standard treatment for patients with acute myeloid leukemia (AML) and\u002For myelodysplastic syndromes (MDS), usually as monotherapy. According to the treatment regimen, azacytidine is prescribed at a standard dose (DS=75mg\u002Fm²\u002Fd), administered subcutaneously every day for 7 days. The treatment cycle is repeated every 28 days.\n\nNo study has evaluated the relevance of \"a priori\" dose adjustment on an individual basis, according to each patient's pharmacogenetic data. In current practice, doses are adapted a posteriori, and reduced empirically, following the occurrence of observed toxicity (6 to 71% of patients) (Schuck A et al. 2017). This ex-post adjustment in the face of grade 3-4 toxicity is a loss of chance for the patient. Similarly, under-dosing patients for fear of toxicity is another loss of chance. Investigator's hypothesis is that the optimal dose of azacytidine depends not only on the characteristics of the patient's pathology (risk groups including cytogenetic and molecular biology data), but also on the patient's individual characteristics (genetic status of metabolic enzymes and transporters). A mathematical model of the PK\u002FPD type could, on the basis of early observations of circulating levels, be capable of rapidly predicting the pharmacodynamic repercussions in each patient, thus enabling rapid individualization of dosages. In the future, such a tool could make it possible to propose dosage adjustments rapidly after treatment initiation, before toxicity occurs, by predicting azacytidine exposure levels, themselves correlated with the patient's clinical condition.\n\nStudy design: In this open-label, paucicentric, non-randomized study, patients with AML and\u002For MDS, all of whom are receiving azacytidine-based chemotherapy as part of their standard treatment regimen, will be included. Each patient will be monitored for toxicities (EORTC), treatment response and progression-free survival. In addition to the standard care described above, each patient will undergo a series of constitutional genetic investigations conducted by NGS on markers linked to azacytidine pharmacokinetics (CDA, dCK). Another series of blood samples will be taken to calculate individual azacytidine pharmacokinetic parameters using a Bayesian approach.\n\nExpected results: This study should make it possible to correlate pharmacogenetics with patient plasma exposure, and ultimately improve the molecule's efficacy\u002Ftoxicity balance by personalizing dosage regimens, which until now have been carried out on an empirical basis.\n\nProspects: If the data are validated, a pre-therapeutic ADC assay could predict azacytidine pharmacodynamics and enable individual dose and\u002For dosage adjustment, as is the case with 5-FU and DPD.",[96,35],"Myelodysplastic Syndromes (MDS)","RECRUITING","2025-03-19",{"date":100,"type":47},"2025-03-20",{"date":102,"type":47},"2021-06-14",{"date":104,"type":22},"2028-06-14",{"name":106,"class":54},"Assistance Publique Hopitaux De Marseille"]