[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100379127":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":399,"centralContacts":403,"locations":409,"responsibleParty":427,"collaborators":429,"id":433,"slug":434,"hasResults":435,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":407,"eligibilityCriteria":439,"healthyVolunteers":435,"sex":440,"minAge":441,"maxAge":407,"enrollmentInfo":442,"targetDuration":407,"studyType":445,"phases":446,"briefSummary":448,"conditions":449,"keywords":407,"overallStatus":412,"whyStopped":407,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},{"fullName":5,"class":6},"M.D. Anderson Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (SL-401, venetoclax, chemotherapy)","EXPERIMENTAL","See detailed description.",[13,14,15,16,17,18,19,20,21,22,23,24],"Drug: Cyclophosphamide","Drug: Cytarabine","Drug: Dexamethasone","Drug: Doxorubicin","Drug: Mercaptopurine","Drug: Methotrexate","Drug: Methylprednisolone","Drug: Prednisone","Biological: Rituximab","Biological: Tagraxofusp-erzs","Drug: Venetoclax","Drug: Vincristine",[26,66,103,170,178,218,258,292,338,369,381,392],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Cyclophosphamide","Given IV",[9],[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65],"(-)-Cyclophosphamide","2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate","Carloxan","Ciclofosfamida","Ciclofosfamide","Cicloxal","Clafen","Claphene","CP monohydrate","CTX","CYCLO-cell","Cycloblastin","Cycloblastine","Cyclophospham","Cyclophosphamid monohydrate","Cyclophosphamide Monohydrate","Cyclophosphamidum","Cyclophosphan","Cyclophosphane","Cyclophosphanum","Cyclostin","Cyclostine","Cytophosphan","Cytophosphane","Cytoxan","Fosfaseron","Genoxal","Genuxal","Ledoxina","Mitoxan","Neosar","Revimmune","Syklofosfamid","WR- 138719",{"type":27,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Cytarabine","Given IT or IV",[9],[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102],".beta.-Cytosine arabinoside","1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-.beta.-D-Arabinofuranosylcytosine","1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone","1-Beta-D-arabinofuranosylcytosine","1.beta.-D-Arabinofuranosylcytosine","2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-","2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-","Alexan","Ara-C","ARA-cell","Arabine","Arabinofuranosylcytosine","Arabinosylcytosine","Aracytidine","Aracytin","Aracytine","Beta-Cytosine Arabinoside","CHX-3311","Cytarabinum","Cytarbel","Cytosar","Cytosine Arabinoside","Cytosine-.beta.-arabinoside","Cytosine-beta-arabinoside","Erpalfa","Starasid","Tarabine PFS","U 19920","U-19920","Udicil","WR-28453",{"type":27,"name":104,"description":105,"armGroupLabels":106,"otherNames":107},"Dexamethasone","Given PO or IV",[9],[108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169],"Aacidexam","Adexone","Aknichthol Dexa","Alba-Dex","Alin","Alin Depot","Alin Oftalmico","Amplidermis","Anemul mono","Auricularum","Auxiloson","Baycadron","Baycuten","Baycuten N","Cortidexason","Cortisumman","Decacort","Decadrol","Decadron","Decadron DP","Decalix","Decameth","Decasone R.p.","Dectancyl","Dekacort","Deltafluorene","Deronil","Desamethasone","Desameton","Dexa-Mamallet","Dexa-Rhinosan","Dexa-Scheroson","Dexa-sine","Dexacortal","Dexacortin","Dexafarma","Dexafluorene","Dexalocal","Dexamecortin","Dexameth","Dexamethasone Intensol","Dexamethasonum","Dexamonozon","Dexapos","Dexinoral","Dexone","Dinormon","Fluorodelta","Fortecortin","Gammacorten","Hexadecadrol","Hexadrol","Lokalison-F","Loverine","Methylfluorprednisolone","Millicorten","Mymethasone","Orgadrone","Spersadex","TaperDex","Visumetazone","ZoDex",{"type":27,"name":171,"description":29,"armGroupLabels":172,"otherNames":173},"Doxorubicin",[9],[174,175,176,177],"Adriablastin","Hydroxydaunomycin","Hydroxyl Daunorubicin","Hydroxyldaunorubicin",{"type":27,"name":179,"description":180,"armGroupLabels":181,"otherNames":182},"Mercaptopurine","Given PO",[9],[183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217],"3H-Purine-6-thiol","6 MP","6 Thiohypoxanthine","6 Thiopurine","6-Mercaptopurine","6-Mercaptopurine Monohydrate","6-MP","6-Purinethiol","6-Thiopurine","6-Thioxopurine","6H-Purine-6-thione, 1,7-dihydro- (9CI)","7-Mercapto-1,3,4,6-tetrazaindene","Alti-Mercaptopurine","Azathiopurine","Bw 57-323H","Flocofil","Ismipur","Leukerin","Leupurin","Mercaleukim","Mercaleukin","Mercaptina","Mercaptopurinum","Mercapurin","Mern","NCI-C04886","Puri-Nethol","Purimethol","Purine, 6-mercapto-","Purine-6-thiol (8CI)","Purine-6-thiol, monohydrate","Purinethiol","Purinethol","U-4748","WR-2785",{"type":27,"name":219,"description":220,"armGroupLabels":221,"otherNames":222},"Methotrexate","Given IT, IV, or PO",[9],[223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257],"Abitrexate","Alpha-Methopterin","Amethopterin","Brimexate","CL 14377","CL-14377","Emtexate","Emthexat","Emthexate","Farmitrexat","Fauldexato","Folex","Folex PFS","Lantarel","Ledertrexate","Lumexon","Maxtrex","Medsatrexate","Metex","Methoblastin","Methotrexate LPF","Methotrexate Methylaminopterin","Methotrexatum","Metotrexato","Metrotex","Mexate","Mexate-AQ","MTX","Novatrex","Rheumatrex","Texate","Tremetex","Trexeron","Trixilem","WR-19039",{"type":27,"name":259,"description":29,"armGroupLabels":260,"otherNames":261},"Methylprednisolone",[9],[262,263,264,265,266,267,268,269,270,271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286,287,288,289,290,291],"Adlone","Caberdelta M","DepMedalone","Depo Moderin","Depo-Nisolone","Duralone","Emmetipi","Esametone","Firmacort","Medlone 21","Medrate","Medrol","Medrol Veriderm","Medrone","Mega-Star","Meprolone","Methylprednisolonum","Metilbetasone Solubile","Metrocort","Metypresol","Metysolon","Predni-M-Tablinen","Prednilen","Radilem","Sieropresol","Solpredone","Summicort","Urbason","Veriderm Medrol","Wyacort",{"type":27,"name":293,"description":180,"armGroupLabels":294,"otherNames":295},"Prednisone",[9],[296,297,298,299,300,301,302,303,304,305,306,307,308,309,310,311,312,313,314,315,316,317,318,319,320,321,322,323,324,325,326,327,328,329,330,331,332,333,334,335,336,337],".delta.1-Cortisone","1, 2-Dehydrocortisone","Adasone","Cortancyl","Dacortin","DeCortin","Decortisyl","Decorton","Delta 1-Cortisone","Delta-Dome","Deltacortene","Deltacortisone","Deltadehydrocortisone","Deltasone","Deltison","Deltra","Econosone","Lisacort","Meprosona-F","Metacortandracin","Meticorten","Ofisolona","Orasone","Panafcort","Panasol-S","Paracort","Perrigo Prednisone","PRED","Predicor","Predicorten","Prednicen-M","Prednicort","Prednidib","Prednilonga","Predniment","Prednisone Intensol","Prednisonum","Prednitone","Promifen","Rayos","Servisone","SK-Prednisone",{"type":339,"name":340,"description":29,"armGroupLabels":341,"otherNames":342},"BIOLOGICAL","Rituximab",[9],[343,344,345,346,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368],"ABP 798","BI 695500","C2B8 Monoclonal Antibody","Chimeric Anti-CD20 Antibody","CT-P10","IDEC-102","IDEC-C2B8","IDEC-C2B8 Monoclonal Antibody","MabThera","Monoclonal Antibody IDEC-C2B8","PF-05280586","Rituxan","Rituximab ABBS","Rituximab Biosimilar ABP 798","Rituximab Biosimilar BI 695500","Rituximab Biosimilar CT-P10","Rituximab Biosimilar GB241","Rituximab Biosimilar IBI301","Rituximab Biosimilar JHL1101","Rituximab Biosimilar PF-05280586","Rituximab Biosimilar RTXM83","Rituximab Biosimilar SAIT101","rituximab biosimilar TQB2303","rituximab-abbs","RTXM83","Truxima",{"type":339,"name":370,"description":29,"armGroupLabels":371,"otherNames":372},"Tagraxofusp-erzs",[9],[373,374,375,376,377,378,379,380],"Diphtheria Toxin(388)-Interleukin-3 Fusion Protein","DT(388)-IL3 Fusion Protein","DT388IL3 fusion protein","Elzonris","IL3R-targeting Fusion Protein SL-401","SL-401","Tagraxofusp","Tagraxofusp ERZS",{"type":27,"name":382,"description":180,"armGroupLabels":383,"otherNames":384},"Venetoclax",[9],[385,386,387,388,389,390,391],"ABT-0199","ABT-199","ABT199","GDC-0199","RG7601","Venclexta","Venclyxto",{"type":27,"name":393,"description":29,"armGroupLabels":394,"otherNames":395},"Vincristine",[9],[396,397,398],"Leurocristine","VCR","Vincrystine",[400],{"name":401,"affiliation":5,"role":402},"Naveen Pemmaraju","PRINCIPAL_INVESTIGATOR",[404],{"name":401,"role":405,"phone":406,"phoneExt":407,"email":408},"CONTACT","713-792-4956",null,"npemmaraju@mdanderson.org",[410],{"facility":411,"status":412,"city":413,"state":414,"zip":415,"country":416,"countryCode":417,"cosmosGeoPoint":418,"geoPoint":423,"contacts":424},"M D Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":419,"coordinates":420},"Point",[421,422],-95.36327,29.76328,{"lat":422,"lon":421},[425,426],{"name":401,"role":405,"phone":406,"phoneExt":407,"email":408},{"name":401,"role":402,"phone":407,"phoneExt":407,"email":407},{"type":428,"investigatorFullName":407,"investigatorTitle":407,"investigatorAffiliation":407,"oldNameTitle":407,"oldOrganization":407},"SPONSOR",[430],{"name":431,"class":432},"National Cancer Institute (NCI)","NIH","100379127","phase-2-venetoclax-sl-401-and-chemotherapy-for-the-treatment-of-blastic-plasmacytoid-dendritic-cell-neoplasm-100379127",false,"NCT04216524","Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm","Phase 2 Clinical Trial for Comprehensive Treatment Program for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Tagraxofusp (SL-401) in Combination With HCVAD\u002FMini-CVD and VENETOCLAX","Inclusion Criteria:\n\n1. Treatment naïve or relapsed refractory patients with histologically confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) per 2016 WHO criteria\n2. Front line participants may have received emergent chemotherapy prior to study enrollment:\n\n   1. One prior cycle of SL-401, or other BPDCN-directed therapy, will be allowed prior to entering the study.\n   2. Prior or concomitant doses of ARA-C (cytarabine) or Hydroxyurea are allowed on before or during the study for proliferative disease due to BPDCN.\n3. Relapsed\u002Frefractory participants may have received at least one prior cycle of therapy.\n4. Age ≥ 18 years\n5. ECOG performance status 0, 1, or 2 (see APPENDIX B)\n6. Adequate organ function as defined by:\n\n   * Albumin ≥ 3.2 g\u002FdL (in the absence of receipt of intravenous albumin in the previous 72 hours)\n   * Serum creatinine \\\u003C 1.5x ULN\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5x ULN\n   * Total bilirubin \\\u003C 1.5x ULN (if total bilirubin is \\> 1.5x but \\\u003C 3x ULN, and thought to be elevated due to Gilbert's disease or the patient's BPDCN, the subject may be eligible but must discuss with the PI)\n7. Ability to understand and the willingness to sign a written informed consent document.\n8. Able to adhere to study visit schedule and other protocol requirements including follow-up for survival assessment\n9. Women of child-bearing potential and men enrolled on this protocol must agree to use adequate contraception for the duration of study participation and for 2 months after completion VEN administration. Acceptable birth control methods allowed to be used while on study include:\n\n   * Birth control pills or injections\n   * Intrauterine devices (IUDs)\n   * Double-barrier methods for example condom in combination with spermicide. Males should not donate sperm while on study and for at least 8 weeks after the last dose of SL-401.\n10. Left ventricular ejection fraction ≥ institutional lower limit of normal by MUGA scan or echocardiogram within 30 days of first protocol treatment.\n\nExclusion Criteria:\n\n1. Participants is pregnant or breastfeeding\n2. Known active hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)\n3. Major surgery or radiation therapy within 14 days prior to the first study dose\n4. Symptomatic or untreated leptomeningeal disease or spinal cord compression\n5. Participants with active heart disease (New York Heart Association (NYHA) class 3-4 as assessed by history and physical examination, unstable angina\u002Fstroke\u002Fmyocardial infarction within the last 6 months)\n6. Malabsorption syndrome or other conditions that preclude enteral route of administration\n7. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and\u002For would make the participants inappropriate for enrollment into this study","ALL","18 Years",{"count":443,"type":444},40,"ESTIMATED","INTERVENTIONAL",[447],"PHASE2","This phase II trial studies how well venetoclax, SL-401, and chemotherapy works in treating patients with blastic plasmacytoid dendritic cell neoplasm. Venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. SL-401 is a recombinant protein consisting of IL-3 linked to a toxic agent called DT. IL-3 attaches to IL-3 receptors on tumor cells in a targeted way and delivers DT to kill them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax and SL-401 with chemotherapy may be an effective treatment for patients with blastic plasmacytoid dendritic cell neoplasm.",[450],"Blastic Plasmacytoid Dendritic Cell Neoplasm","2026-04-09",{"date":453,"type":454},"2026-04-14","ACTUAL",{"date":456,"type":454},"2020-05-29",{"date":458,"type":444},"2026-12-31",{"name":5,"class":6},1]