[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100294495":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":43,"locations":51,"responsibleParty":102,"collaborators":104,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":32,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":32,"enrollmentInfo":117,"targetDuration":32,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":54,"whyStopped":32,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Dana-Farber Cancer Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"SL-401+ Azacitidine","EXPERIMENTAL","SL-401 will be administered every 4 weeks, on a 28 day cycle; SL-401 will be given intravenously; Azacitidine will be administered every 4 weeks, on a 28 day cycle; Azacitidine will be given intravenously or subcutaneously",[13,14],"Drug: Azacitidine","Drug: SL-401",{"label":16,"type":10,"description":17,"interventionNames":18},"SL-401+ Azacitidine + Venetoclax","SL-401 will be administered every 4 weeks, on a 28 day cycle; SL-401 will be given intravenously; Azacitidine will be administered every 4 weeks, on a 28 day cycle; Azacitidine will be given intravenously or subcutaneously; Venetoclax will be administered for 21 days on a 28 day cycle; Venetoclax will be taken orally",[13,14,19],"Drug: Venetoclax",[21,28,33],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Azacitidine","Chemotherapy",[9,16],[27],"Vidaza",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"SL-401","SL-401 works by targeting leukemia cells (blasts), and also possibly by stopping or slowing the growth of cancer stem cells, which are the undeveloped cells which can develop into cancer cells.",[9,16],null,{"type":22,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Venetoclax","Venetoclax is a BH3-mimetic. Venetoclax blocks the anti-apoptotic B-cell lymphoma-2 (Bcl-2) protein, leading to programmed cell death of CLL cells. Overexpression of Bcl-2 in some lymphoid malignancies has sometimes shown to be linked with increased resistance to chemotherapy.",[16],[38],"Venclyxto, Venclexta",[40],{"name":41,"affiliation":5,"role":42},"Andrew Lane, MD, PhD","PRINCIPAL_INVESTIGATOR",[44,48],{"name":41,"role":45,"phone":46,"phoneExt":32,"email":47},"CONTACT","857-215-1405","andrew_lane@dfci.harvard.edu",{"name":49,"role":45,"phone":32,"phoneExt":32,"email":50},"Veronica Zehnder","veronica_zehnder@dfci.harvard.edu",[52,72,86],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"City of Hope","RECRUITING","Duarte","California","91010","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-117.97729,34.13945,{"lat":64,"lon":63},[67,71],{"name":68,"role":45,"phone":69,"phoneExt":32,"email":70},"Anthony Stein, MD","626-359-8111","AStein@coh.org",{"name":68,"role":42,"phone":32,"phoneExt":32,"email":32},{"facility":73,"status":54,"city":74,"state":75,"zip":76,"country":58,"countryCode":59,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Dana Farber Cancer Institute","Boston","Massachusetts","02215",{"type":61,"coordinates":78},[79,80],-71.05977,42.35843,{"lat":80,"lon":79},[83,84,85],{"name":41,"role":45,"phone":32,"phoneExt":32,"email":47},{"name":49,"role":45,"phone":32,"phoneExt":32,"email":50},{"name":41,"role":42,"phone":32,"phoneExt":32,"email":32},{"facility":87,"status":54,"city":88,"state":89,"zip":90,"country":58,"countryCode":59,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":61,"coordinates":92},[93,94],-95.36327,29.76328,{"lat":94,"lon":93},[97,101],{"name":98,"role":45,"phone":99,"phoneExt":32,"email":100},"Naveen Pemmaraju, MD","713-792-4956","npemmaraju@mdanderson.org",{"name":98,"role":42,"phone":32,"phoneExt":32,"email":32},{"type":42,"investigatorFullName":103,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Andrew Lane",[105],{"name":106,"class":107},"Stemline Therapeutics, Inc.","INDUSTRY","100294495","phase-1-sl-401-in-combination-with-azacitidine-or-azacitidinevenetoclax-in-acute-myeloid-leukemia-aml-high-risk-myelodysplastic-syndrome-mds-or-blastic-plasmacytoid-dendritic-cell-neoplasm-bpdcn-100294495",false,"NCT03113643","SL-401 in Combination With Azacitidine or Azacitidine\u002FVenetoclax in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)","Phase 1 Study of SL-401 in Combination With Azacitidine and Venetoclax in Relapsed\u002FRefractory Acute Myeloid Leukemia (AML) and in Treatment-Naive Subjects With AML Not Eligible for Standard Induction and in Subjects With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) or SL-401 in Combination With Azacitidine in Subjects With High-Risk Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\nHistologically confirmed diagnosis of acute myeloid leukemia (AML) \\[Cohort B\\] or myelodysplastic syndrome (MDS) \\[Cohort A\\] or BPDCN \\[Cohort C\\] per 2016 WHO criteria\n\nCD123 \u002F IL3RA expression on the subject's AML or MDS blasts or BPDCN cells determined locally within 3 months of first protocol treatment\n\nAge \\>= 18 years with relapsed or refractory AML (hydroxyurea is not considered a prior treatment regimen) \\[Cohort B\\]\n\nOR\n\nAge \\>= 18 years with treatment-naïve AML who decline intensive induction chemotherapy or who are unfit due to co-morbidity or other factors (see APPENDIX A for unfitness definitions) (hydroxyurea is not considered a prior treatment regimen) \\[Cohort B\\]\n\nOR\n\nAge \\>= 18 years with MDS and \\> 10% myeloblasts in the bone marrow \\[Cohort A\\]\n\nOR\n\nAge \\>= 18 years with relapsed or refractory BPDCN (hydroxyurea is not considered a prior treatment regimen) \\[Cohort C\\]\n\nAdequate organ function as defined by:\n\nAlbumin \\> 3.2 g\u002FdL (in the absence of receipt of intravenous albumin in the previous 72 hours) Serum creatinine \\\u003C 1.5x ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5x ULN Total bilirubin \\\u003C 1.5x ULN (if thought to be \\> 1.5x ULN due to Gilbert's disease or the patient's AML, must discuss with the PI) Creatine phosphokinase (CPK) \\\u003C 2.5x ULN Left ventricular ejection fraction \\> institutional lower limit of normal by MUGA scan or echocardiogram within 30 days of first protocol treatment\n\n\\[Cohorts B and C\\] WBC \\\u003C 20,000 \u002F uL on day of first therapy, cytoreduction may be achieved using hydroxyurea\n\nAbility to understand and the willingness to sign a written informed consent document.\n\nAble to adhere to study visit schedule and other protocol requirements including follow-up for survival assessment\n\nWomen of child-bearing potential must agree to use adequate contraception for the duration of study participation and for 2 months after completion of protocol treatment.\n\nMen treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and 2 months after completion of protocol treatment.\n\nExclusion Criteria:\n\nPrior treatment with venetoclax \\[Cohorts B or C\\], unless it was last taken \\>2 months before protocol therapy\n\nDiagnosis of acute promyelocytic leukemia\n\nReceived treatment with chemotherapy, radiation, or biologic cancer therapy within 14 days of first protocol treatment, except for intrathecal chemotherapy. Prior and concurrent hydroxyurea is permitted.\n\nHematopoietic stem cell transplantation (HSCT) within 60 days of screening or active graft versus-host-disease\n\nActive CNS involvement by AML or BPDCN. Screening lumbar puncture (LP) required for patients with BPDCN. If history of treated CNS involvement, must have had two consecutive negative LPs since last CNS involvement, which may include the screening LP\n\nKnown positive status for HIV infection; known active hepatitis B or hepatitis C infection\n\nClinically significant cardiopulmonary disease including uncontrolled or NYHA class 3 or 4 congestive heart failure, uncontrolled angina, uncontrolled hypertension, uncontrolled arrhythmia, myocardial infarction or stroke within 6 months of first protocol treatment, or QTc \\> 480 ms\n\nPatients with known active advanced malignant solid tumors are excluded (except for basal or squamous skin cancers, or carcinomas in situ). Patients with additional hematologic malignancies that require treatment are excluded.\n\nPregnant women are excluded from this study because there is an unknown but potential risk for adverse events in the developing fetus with SL-401, azacitidine, and venetoclax (negative urine or serum pregnancy test required within 14 days of Cycle 1, Day 1). Because nursing infants have unknown potential for adverse events secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with SL-401, azacitidine, and venetoclax.\n\nPatients with uncontrolled infection shall not be enrolled until infection is treated and brought under control. Patients with active infection are permitted to enroll provided that the infection is controlled\n\n\\[Cohorts B and C\\] Patients with gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, a requirement for intravenous (IV) alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis)\n\n\\[Cohorts B and C\\] Patients on strong CYP3A inducers within 7 days of first dose of study treatment.","ALL","18 Years",{"count":118,"type":119},72,"ESTIMATED","INTERVENTIONAL",[122],"PHASE1","This research study is studying a drug as a possible treatment for diagnosis of AML, BPDCN and high-risk MDS.\n\nThe interventions involved in this study are:\n\n* SL-401\n* Azacitidine\n* Venetoclax",[125,126,127],"Acute Myeloid Leukemia","Myelodysplastic Syndrome","Blastic Plasmacytoid Dendritic Cell Neoplasm",[125,126,127,129],"BPDCN","2026-06-15",{"date":132,"type":133},"2026-06-17","ACTUAL",{"date":135,"type":133},"2017-06-26",{"date":137,"type":119},"2027-05-31",{"name":5,"class":6},3]