[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"higher-risk-myelodysplastic-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:higher-risk-myelodysplastic-syndrome":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,71,96],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100367769","phase-1-study-to-evaluate-ccs1477-inobrodib-in-haematological-malignancies-100367769",false,"NCT04068597","Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies","An Open-label Phase I\u002FIIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.","Inclusion Criteria:\n\n* Provision of consent\n* ECOG performance status 0-2\n* Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)\n* Must have previously received standard therapy\n* Adequate organ function\n\nExclusion Criteria:\n\n* Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose\n* Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment\n* Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment\n* Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment\n* Patients should discontinue statins prior to starting study treatment\n* CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment\n* Any unresolved reversible toxicities from prior therapy \\>CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)\n* Any evidence of severe or uncontrolled systemic diseases\n* Any known uncontrolled inter-current illness\n* QTcF prolongation (\\> 470 msec)","ALL","18 Years",{"count":19,"type":20},250,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","A Phase 1\u002F2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.",[27,28,29,30,31,32],"Haematological Malignancy","Acute Myeloid Leukemia","Non Hodgkin Lymphoma","Multiple Myeloma","Higher-risk Myelodysplastic Syndrome","Peripheral T Cell Lymphoma","RECRUITING","2026-06-19",{"date":36,"type":37},"2026-06-24","ACTUAL",{"date":39,"type":37},"2019-08-09",{"date":41,"type":20},"2027-03-31",{"name":43,"class":44},"CellCentric Ltd.","INDUSTRY",39,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100622522","phase-1-first-in-human-fih-trial-of-gen3018-in-relapsed-or-refractory-rr-acute-myeloid-leukemia-aml-or-higher-risk-myelodysplastic-syndrome-hr-mds-100622522","NCT07384715","First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R\u002FR) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)","An Open-Label, Multicenter, First-in-Human Trial of GEN3018 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndrome","Key Inclusion Criteria:\n\nAll Participants:\n\n* Be at least 18 years of age at the time of signing informed consent form (ICF).\n* Participant's life expectancy at screening is judged to be at least 3 months.\n* Must have fresh bone marrow samples collected at screening.\n* Bone marrow (BM) blasts ≥ 5% at screening.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2.\n* Has acceptable laboratory test results during the screening period\n\nParticipants with R\u002FR AML:\n\n* Relapsed or refractory AML, either de novo or secondary, and must have failed all conventional therapies.\n* Relapsed or refractory to at least one prior line of therapy.\n\nParticipants with R\u002FR HR-MDS:\n\n* Diagnosed with high- or very-high risk MDS according to International Prognostic Scoring System (IPSS-R) (score of \\> 4.5 ie, high or very high) or World Health Organization (WHO) 2022 classification (ie, MDS-IB1 or MDS-IB2).\n* Refractory or relapsed after hypomethylating agents (HMAs) (such as azacitidine or decitabine).\n\nKey Exclusion Criteria:\n\nAll Participants:\n\n* Diagnosis of acute promyelocytic leukemia (APL).\n* Presence of extramedullary AML at screening.\n* Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) within 3 months prior to initiation of trial treatment.\n* Active graft-versus-host disease.\n* History of severe immune-related adverse events.\n* Treatment with anti-cancer agent (eg, small molecule, antibody, chemotherapy, radiation therapy), or major surgery within 2 weeks prior to the first dose of GEN3018.\n\nOther protocol-defined Inclusion and Exclusion criteria may apply.",{"count":54,"type":20},78,[23],"The drug that will be investigated in the trial is an antibody, GEN3018. Since this is the first trial of GEN3018 in humans, the main purpose is to evaluate safety. In addition to safety, the trial will determine the recommended GEN3018 dose(s) to be tested in a larger group of participants and assess preliminary anti-tumor activity of GEN3018. GEN3018 will be studied in refractory (resistant to treatment) or relapsed (disease has returned) acute myeloid leukemia (also known as R\u002FR AML) and refractory or relapsed higher-risk myelodysplastic syndrome (also known as R\u002FR HR-MDS). The trial consists of 2 parts:\n\n1. Part 1 Dose Escalation will test increasing doses of GEN3018 to identify a safe dose level to be tested in the next part\n2. Part 2 Dose Refinement will further test the GEN3018 dose(s) determined from the Dose Escalation.\n\nUp to 78 participants may be treated in this trial (up to 60 participants in Part 1; up to 18 participants in Part 2).\n\nFor an individual participant in the trial, the estimated treatment duration will be up to 1 year. Participation in the trial will require regular scheduled visits to the site. At site visits, there will be various tests (such as blood draws) to monitor whether the treatment is safe and effective. Participants will also be contacted every 3 months after treatment ends to monitor how they are doing.\n\nAll participants in the trial will receive active drug (ie, GEN3018); no one will be given placebo.",[58,59,28,60],"R\u002FR AML","R\u002FR HR-MDS","Higher-Risk Myelodysplastic Syndrome","2026-06-01",{"date":63,"type":37},"2026-06-02",{"date":65,"type":37},"2026-02-16",{"date":67,"type":20},"2030-04-20",{"name":69,"class":44},"Genmab",9,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100565379","phase-3-lisaftoclax-apg-2575-combined-with-azacytidine-aza-in-the-treatment-of-patients-with-higher-risk-myelodysplastic-syndrome-glora-4-100565379","NCT06641414","Lisaftoclax (APG-2575) Combined With Azacytidine (AZA) in the Treatment of Patients With Higher-risk Myelodysplastic Syndrome (GLORA-4).","A Global Multicenter, Double-blind, Randomized, Registrational Phase 3 Study of Lisaftoclax (APG-2575) in Combination With Azacitidine (AZA) in Patients With Newly Diagnosed Higher Risk Myelodysplastic Syndrome (HR-MDS) (GLORA-4).","Inclusion Criteria:\n\n1. Newly diagnosed higher-risk MDS.\n2. ECOG score of ≤2.\n3. Expected survival ≥ 3 months.\n4. Adequate organ function.\n5. Female subjects of potential childbearing potential have a negative urine or serum pregnancy test before dosing. Subjects of childbearing potential as well as their partners voluntarily use contraception deemed effective by the investigator during the treatment period and for at least six months after the last dose of study drug.\n6. Able to understand and voluntarily sign a written informed consent form, which must be signed prior to the performance of any trial-specified study procedures.\n7. Subjects are able to complete study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n1. Concomitant other malignancies or prior malignancies with disease-free intervals of less than 1 year at the time of signing the informed consent.\n2. Have undergone hematopoietic stem cell transplantation.\n3. Uncontrolled active infection\n4. Use of moderately potent inducers and moderately potent inhibitors of CYP3A4 within 14 days prior to the first dose of study drug.\n5. MDS or other conditions that cannot be administered enterally.\n6. Any condition that the subject is deemed to be inappropriate to participate in this study after evaluation by the investigator.",{"count":79,"type":20},490,[81],"PHASE3","A global multicenter, randomized, double-blind, placebo-controlled, pivotal phase III study. To evaluate overall survival (OS) of Lisaftoclax (APG-2575) combined with azacitidine (AZA) vs. placebo combined with azacitidine in newly diagnosed patients with HR-MDS.",[31],[31,85],"Lisaftoclax","2025-11-18",{"date":88,"type":37},"2025-11-20",{"date":90,"type":37},"2025-01-22",{"date":92,"type":20},"2029-12",{"name":94,"class":44},"Ascentage Pharma Group Inc.",2,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100587349","phase-3-azalus-vs-aza-monotherapy-in-hr-mds-100587349","NCT06927232","AZA+Lus VS AZA Monotherapy in HR-MDS","Azacitidine Plus Luspatercept Versus Azacitidine Monotherapy in Higher-risk Myelodysplastic Neoplasms: a Randomized Prospective Study","Inclusion Criteria:\n\n* Age ≥18 years old\n* Diagnosed as higher-risk MDS (IPSS intermediate-2\u002Fhigh-risk, or IPSS-R \\>3.5, or IPSS-M moderate high-, high-, very high-risk)\n* Untreated patients\n* Liver and kidney function less than 2 times of upper limit of normal\n* ECOG≤2 and expected survival more than 6 months\n* Informed consent signed\n\nExclusion Criteria:\n\n* With active infection\n* Other malignant tumors\n* Obvious abnormal liver and kidney function, or abnormal function of other organs\n* Combined with myelofibrosis\n* Have undergone bone marrow transplantation\n* Pregnant or lactating women, or men who have recent reproductive needs\n* Allergic to azacytidine, Rotercept or excipients\n* History of polysorbate 80 allergy\n* Refuse to sign informed consent\n* Researchers consider it inappropriate to participate in the experiment",{"count":104,"type":20},86,[81],"This study is a randomized, prospective, single-center, open-label cohort study involving untreated HR-MDS patients. The patients were divided randomized into AZA+Lus cohort and AZA monotherapy cohort.",[31],[109,110,111],"luspatercept","azacitidine","higher-risk myelodysplastic syndrome","NOT_YET_RECRUITING","2025-04-13",{"date":115,"type":37},"2025-04-15",{"date":117,"type":20},"2025-04",{"date":119,"type":20},"2027-01-31",{"name":121,"class":122},"Peking Union Medical College Hospital","OTHER"]