[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562115":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":53,"collaborators":20,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":80,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm","EXPERIMENTAL","This trial is designed to evaluate the antileukemic activity of an Total bone marrow and lymphoid irradiation\u002Fcyclophosphamide\u002Fetoposide conditioning regimen for allogeneic hematopoietic stem cell transplantation, in patients with high-risk myelodysplastic syndromes and acute myeloid leukemia, as assessed by 2-year progression-free survival. The first 6-18 patients enrolled\u002Ftreated in this study will be part of a safety sub-analysis, so patients will be assigned to the dose level that is currently open once they are verified to be eligible; up to three dose levels can be studied.",[13],"Drug: Total bone marrow and lymphoid irradiation\u002Fcyclophosphamide\u002Fetoposide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Total bone marrow and lymphoid irradiation\u002Fcyclophosphamide\u002Fetoposide","Evaluate the antileukemic activity of an total bone marrow and lymphoid irradiation\u002Fcyclophosphamide\u002Fetoposide conditioning regimen for allogeneic hematopoietic stem cell transplantation",[9],null,[22],{"name":23,"affiliation":24,"role":25},"José Antonio Pérez Simón, MD-PhD","Fundación para la Gestión de la Investigación en Salud de Sevilla","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+34955013260","josea.perez.simon.sspa@juntadeandalucia.es",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Clara M Rosso Fernández, MD-PhD","+34955013414","claram.rosso.sspa@juntadeandalucia.es",[36],{"facility":37,"status":20,"city":38,"state":20,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Hospital Universitario Virgen del Rocío","Seville","41013","Spain","ES",{"type":43,"coordinates":44},"Point",[45,46],-5.97317,37.38283,{"lat":46,"lon":45},[49],{"name":50,"role":28,"phone":51,"phoneExt":52,"email":30},"Jose-Antonio Perez-Simon","0034955013260","0034",{"type":54,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100562115","phase-2-tmli-plus-chemotherapy-in-high-risk-myelodysplastic-syndrome-or-acute-myeloid-leukemia-100562115",false,"NCT06598969","TMLI Plus Chemotherapy in High Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia","Phase II Study of TMLI Administered in Combination With a Myeloablative Regimen (Cyclophosphamide + Etoposide) for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With High-risk Myelodysplastic Syndrome or Acute Myeloid Leukemia","TMLI-MA","Inclusion Criteria:\n\n* The participant has the ability and willingness to sign the informed consent document\n* Age ≥18 to ≤50 years.\n* Karnofsky's performance status should be ≥70%.\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukemia or acute myeloid leukemia with relapsed\u002Frefractory active disease, or in complete remission or morphologic leukemia-free state with evidence of measurable residual disease as assessed by multiparameter flow cytometry (≥ 0,1%) or next-generation sequencing\n* All candidates for this study must have an Human leukocyte antigens (A, B, C, DR) identical siblings who are willing to donate bone marrow or peripheral blood hematopoietic progenitors or an 8\u002F8 matched unrelated donor. A single allele mismatch in A, B, C or DR beta chain 1 shall be allowed\n* Total bilirubin ≤ 1.5 x upper limit of normal or 3 x upper limit of normal for Gilbert's disease.\n* serum glutamate oxaloacetate transaminase \\& serum glutamate pyruvate transaminaseT ≤ 5 x upper limit of normal.\n* Serum creatinine ≤ 1.3 mg\u002FdL or creatinine clearance measured ≥ 80 mL\u002Fmin for 24 hours of urine collection\n* Women of childbearing age only: Negative urine or serum pregnancy test\n* Pulmonary function tests: forced expiratory volume in one second and Carbon Monoxide Diffusion Capacity (adjusted for Hb) ≥ 50% from expected normal value\n* Patients should undergo cardiac evaluation with an electrocardiogram showing no ischemic changes or clinically relevant arrhythmia, and a ≥50% ejection fraction established by Multi-Gated Acquisition Scan or echocardiogram\n* Men and women of childbearing potential agree to use appropriate contraceptives (hormonal or barrier contraception or abstinence) prior to study entry and for six months following the duration of study participation\n* The time elapsed since the end of the last induction or reinduction cycle must be greater than or equal to 14 days\n\nExclusion Criteria:\n\n* Patients who have received a previous autologous (within the last year) or allogeneic transplant (at any time) are excluded\n* Previous radiation therapy, which would preclude the use of total bone marrow and lymphoid irradiation\n* Plans during the trial to receive any other investigational (non-trial-related) agents\n* Uncontrolled disease, including ongoing or active infection\n* History of allergic reactions attributed to compounds of chemical or biological composition similar to cyclophosphamide or etoposide\n* Patients with other active malignancies are not eligible for this study, other than the malignancies discussed\n* Patients with a psychological or medical condition that the patient's physician deems unacceptable to proceed with allogeneic hematopoietic stem cell transplantation\n* Women who plan to become pregnant or breastfeed during the trial\n* Patients who do not agree to practice effective forms of contraception\n* Subjects who, in the opinion of the investigator, may not be able to meet the safety control requirements of the study","ALL","18 Years","50 Years",{"count":67,"type":68},58,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","Single-arm, single-center phase II trial to evaluate the antileukemic activity and safety\u002Ftolerability of TMLI\u002Fcyclophosphamide and etoposide conditioning regimen followed by allogeneic hematopoietic stem cell transplantation in patients with high-risk myelodysplastic syndrome or acute myeloid leukemia.",[74,75],"Myelodysplastic Syndromes","Myeloid Leukemia, Acute",[77,78,79],"High-Risk myelodysplastic syndrome","Acute myeloid leukemia","Total narrow and lymphoid irradiation","NOT_YET_RECRUITING","2024-09-16",{"date":83,"type":84},"2024-09-19","ACTUAL",{"date":86,"type":68},"2024-12-30",{"date":88,"type":68},"2028-12-30",{"name":5,"class":6},1]