[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"blastic-plasmacytoid-dendritic-cell-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:blastic-plasmacytoid-dendritic-cell-neoplasm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,74,116,138],{"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":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"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":19,"type":20},72,"ESTIMATED","INTERVENTIONAL",[23],"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",[26,27,28],"Acute Myeloid Leukemia","Myelodysplastic Syndrome","Blastic Plasmacytoid Dendritic Cell Neoplasm",[26,27,28,30],"BPDCN","RECRUITING","2026-06-15",{"date":34,"type":35},"2026-06-17","ACTUAL",{"date":37,"type":35},"2017-06-26",{"date":39,"type":20},"2027-05-31",{"name":41,"class":42},"Dana-Farber Cancer Institute","OTHER",3,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100467132","phase-1-a-study-of-mgd024-in-patients-with-relapsed-or-refractory-hematologic-malignancies-100467132","NCT05362773","A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies","A Phase 1, First-in-Human, Dose Escalation Study of MGD024, a CD123 x CD3 Bispecific DART Molecule, in Patients With Select Relapsed or Refractory Hematologic Malignancies","Inclusion Criteria:\n\n* Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures.\n* Participants with\n\n  * primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia,\n  * primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \\>3 and \\\u003C20% bone marrow blasts,\n  * classical Hodgkin lymphoma (cHL),\n  * chronic myelogenous leukemia (CML),\n  * b-cell acute lymphocytic leukemia (B-ALL),\n  * hariy cell leukemia (HCL),\n  * advanced systemic mastocytosis (ASM), or\n  * blastic plasmacytoid dendritic cell neoplasm (BPDCM)\n* Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option.\n* Evidence of at least 20% of malignant cells with CD123 expression.\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Life expectancy of at least 12 weeks.\n* Acceptable laboratory values, and heart function.\n* Continuing side effects of prior treatment are mild\n* Women and men of childbearing potential must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024.\n\nExclusion Criteria:\n\n* Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp).\n* Known involvement of central nervous system (CNS) by the disease under investigation.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.\n* Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose\n* Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.",{"count":52,"type":20},130,[23],"CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment. The study is designed to determine the safety, tolerability, pharmacokinetics (affect of the body on the drug), pharmacodynamic (affect of the drug on the body), immunogenicity (development of antibodies against the drug), and preliminary anti-cancer effect of MGD024.\n\nParticipants will receive treatment with MGD024 in consecutive 28-day cycles for a study treatment period of up to 12 cycles (approximately 1 year) or until treatment or study discontinuation criteria are met. Response assessments will be performed after Cycle 1 and then after every even numbered cycle starting with Cycle 2 until progression or study treatment discontinuation. Participants will be checked for side effects throughout the study.",[56,57,58,59,60,61,28,62],"Leukemia, Acute Myeloid","Myelodysplastic Syndromes","Classical Hodgkin Lymphoma","Leukemia, B-cell","Leukemia, Hairy Cell","Mastocytosis, Aggressive Systemic","Chronic Myeloid Leukemia","2026-05-20",{"date":65,"type":35},"2026-05-22",{"date":67,"type":35},"2022-07-13",{"date":69,"type":20},"2027-05",{"name":71,"class":72},"MacroGenics","INDUSTRY",7,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100345603","phase-2-naive-t-cell-depletion-for-preventing-chronic-graft-versus-host-disease-in-children-and-young-adults-with-blood-cancers-undergoing-donor-stem-cell-transplant-100345603","NCT03779854","Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant","Multi-Center Phase II Randomized Controlled Trial of Naïve T Cell Depletion for Prevention of Chronic Graft-Versus-Host Disease in Children and Young Adults","Inclusion Criteria:\n\n* The patient must have one of the following diagnoses and be considered to be an appropriate candidate for allogeneic HCT by the study site principal investigator (PI):\n\n  * Acute lymphoblastic leukemia (ALL) with \\\u003C 5% marrow blasts.\n  * Acute myeloid leukemia (AML) with \\\u003C 25% marrow blasts.\n  * Other acute leukemia (OAL) or related neoplasm (including but not limited to acute biphenotypic leukemia \\[ABL\\], ambiguous lineage \\[ALAL\\], mixed phenotype acute leukemia \\[MPAL\\], blastic plasmacytoid dendritic cell neoplasm \\[BPDCN\\], acute undifferentiated leukemia \\[AUL\\], lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia, chronic monocytic leukemia \\[CML\\] with blast crisis or other chronic myeloproliferative neoplasm) with \\\u003C 5% marrow blasts.\n  * Myelodysplastic syndrome (MDS) with excess blasts (EB-1 and EB-2) and has received cytotoxic induction chemotherapy (excluding small molecule inhibitors and de-methylating agents)\n* Age 6 months to 26 years at the time informed consent is obtained using the Informed Consent to Participate in a Research Study form\n* Matched related donor (MRD) or matched unrelated donor (MUD) (defined as 8\u002F8 match for human leukocyte antigen \\[HLA\\]-A, -B, -C, -DRB1).\n* Planned product type for infusion is PBSC or BM (i.e. not cord blood):\n\n  * For feasibility phase, planned product type for infusion must be PBSC.\n  * For RCT, planned product type must be PBSC or BM.\n* Karnofsky or Lansky score \\>= 60%.\n* Left ventricular ejection fraction (LVEF) at rest \\>= 40%.\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for hemoglobin) \\>= 60% predicted by pulmonary function tests (PFTs)\n\n  \\* Patients who are unable to perform PFTs (age \\\u003C 6 years or considered developmentally incapable of PFTs): oxygen saturation (by oximetry) must be \\>= 92% on room air.\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal (GI) physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Alanine aminotransferase (ALT), aspartate aminotransferase (AST) =\\\u003C 2 x ULN (unless value\\[s\\] \\> 2 x ULN are disease- or medication-related).\n\n  \\* If value(s) are \\> 2 x ULN and not disease- or medication related, patient must be evaluated by a gastrointestinal GI physician. If GI physician considers protocol treatment to be contraindicated for the patient, the patient will not be eligible for the study.\n* Serum creatinine (SCr) within normal range for age. If SCr is outside normal range for age, creatinine clearance (CrCl) \\> 40 mL\u002Fmin\u002F1.73m\\^2 must be obtained (measured by 24-hour \\[hr\\] urine specimen or nuclear glomerular filtration rate \\[GFR\\]).\n\n  * Age (Years): Maximum SCr (mg\u002FdL)\n  * =\\\u003C 5: 0.8\n  * 6-10: 1\n  * 11-15: 1.2\n  * \\> 15: 1.5\n* Recipient informed consent\u002Fassent\u002Flegal guardian permission documentation must be obtained.\n* DONOR: May be related (MRD) or unrelated (MUD) to the subject.\n* DONOR: Must be matched to the subject at 8\u002F8 HLA alleles (HLA-A, -B, -C, and -DRB1)\n* DONOR: Be \\>=14 years of age.\n* DONOR: Must be available to donate in the United States of America (USA) (i.e. excludes international donors).\n* DONOR: Must agree to donate BM or PBSC (i.e. agree to donate whichever product type is requested) (applicable only to the RCT phase of this study).\n* DONOR: MUDs:\n\n  * Must give informed consent according to applicable National Marrow Donor Program (NMDP) donor regulatory requirements\n  * Must meet eligibility criteria as defined by the NMDP or be ineligible with statement of urgent medical need (exception 21 CFR 1271.65(b)(iii))\n\n    * Tests must be performed using Food and Drug Administration (FDA) licensed, cleared, and approved test kits in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory\n* DONOR: MRDs:\n\n  * Must be negative for human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2, hepatitis B, hepatitis C (serological and\u002For nucleic acid testing \\[NAT\\] and\u002For other approved testing)\n  * Must meet institutional donor eligibility criteria, or be ineligible with statement that the donor is a first or second degree relative (exception 21 CRF 1271.65(b)(i)).\n\n    * Tests must be performed using FDA licensed, cleared, and approved test kits in a CLIA-certified laboratory.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease. A patient may have a history of CNS disease; however, any CNS disease must be cleared by the end of the pre-conditioning evaluation. If CNS disease is identified on the first cerebrospinal fluid (CSF) evaluation within 30 days of the start of the preparative regimen, a repeat CSF evaluation must be performed and show no evidence of disease in order for the patient to be eligible for the protocol.\n* Patients on other experimental protocols for the prevention of GVHD.\n* Patient body weight:\n\n  * Matched related donor (MRD): \\> 100 kg are ineligible\n  * Matched unrelated donor (MUD): \\> 75 kg must be discussed with the protocol principal investigator (PI) prior to enrollment.\n* HIV-positive.\n* Uncontrolled infections must be evaluated by an infectious disease physician and considered suitable to undergo HCT by the study site PI, infectious disease physician and protocol PI. Upper respiratory tract infection (URI) does not constitute an uncontrolled infection in this context.\n* Life expectancy \\\u003C 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS).\n* Significant medical condition that would make recipient unsuitable for HCT.\n* Prior allogeneic or autologous HCT.\n* Females who are pregnant or breastfeeding.\n* Patients of child bearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during study treatment and for 12 months following HCT.\n* Known hypersensitivity to tacrolimus, fludarabine, or methotrexate (MTX).",true,"6 Months","26 Years",{"count":85,"type":20},68,[87],"PHASE2","This phase II trial studies how well naive T-cell depletion works in preventing chronic graft-versus-host disease in children and young adults with blood cancers undergoing donor stem cell transplant. Sometimes the transplanted white blood cells from a donor attack the body's normal tissues (called graft versus host disease). Removing a particular type of T cell (naive T cells) from the donor cells before the transplant may stop this from happening.",[90,91,92,93,94,95,28,96,97,98,99,100,101,102,103,104,105],"Acute Biphenotypic Leukemia","Acute Leukemia","Acute Leukemia of Ambiguous Lineage","Acute Lymphoblastic Leukemia","Acute Undifferentiated Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation Recipient","Blasts Under 25 Percent of Bone Marrow Nucleated Cells","Blasts Under 5 Percent of Bone Marrow Nucleated Cells","Mixed Phenotype Acute Leukemia","Myelodysplastic Syndrome With Excess Blasts-1","Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Burkitt Leukemia","Chronic Monocytic Leukemia","Lymphoblastic Lymphoma","Mast Cell Leukemia","Myeloproliferative Neoplasm","2026-05-11",{"date":108,"type":35},"2026-05-14",{"date":110,"type":35},"2019-08-29",{"date":112,"type":20},"2028-12-31",{"name":114,"class":42},"Fred Hutchinson Cancer Center",10,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":137},"100379127","phase-2-venetoclax-sl-401-and-chemotherapy-for-the-treatment-of-blastic-plasmacytoid-dendritic-cell-neoplasm-100379127","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",{"count":124,"type":20},40,[87],"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.",[28],"2026-04-09",{"date":130,"type":35},"2026-04-14",{"date":132,"type":35},"2020-05-29",{"date":134,"type":20},"2026-12-31",{"name":136,"class":42},"M.D. Anderson Cancer Center",1,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":145,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":137},"100517121","phase-2-cord-blood-transplant-cyclophosphamide-fludarabine-and-total-body-irradiation-in-treating-patients-with-high-risk-hematologic-diseases-100517121","NCT06013423","Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases","Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults and Pediatrics","Inclusion Criteria:\n\n* Patients aged 6 months to =\\\u003C 65 years at time of consent.\n* Acute myelogenous leukemia (AML):\n\n  * Complete first remission (CR1), complete second remission (CR2) or greater (CR2+), must have \\\u003C 5% marrow blasts at the time of transplant.\n  * Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible.\n* Acute lymphoblastic leukemia (ALL):\n\n  * Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n    * Presence of any high-risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other MLL rearrangements (11q23) or other high-risk molecular abnormality.\n    * Failure to achieve MRD- complete remission after induction therapy.\n    * Persistence or recurrence of minimal residual disease on therapy.\n    * Any patient unable to tolerate consolidation and\u002For maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n    * Other high-risk features not defined above.\n  * Complete second remission (CR2) or greater (CR2+).\n\n    * Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n* Chronic Myeloid Leukemia (CML): Excluding refractory blast crisis. To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy.\n* Myelodysplastic syndromes (MDS) and myeloproliferative disorders (MPD) other than myelofibrosis:\n\n  * MDS\u002FMPD overlap syndromes without myelofibrosis.\n  * MDS\u002F MPD patients must have less than 10% bone marrow myeloblasts and absolute neutrophil count (ANC) \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n* Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\n  * Eligible patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histology) in CR by PET\u002FCT imaging.\n  * Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with PR or CR by PET\u002FCT imaging.\n* Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n* Only for adult patients, to prevent graft rejection, patients who received only non-lymphodepleting agents for their malignancy (hypomethylating agents, venetoclax, hydroxyurea, TKIs etc.), or patients who received lymphodepleting chemotherapy \\> 3 months prior to scheduled admission, may receive fludarabine 25 mg\u002Fm\\^2 daily x 3 days for lymphodepletion 14-42 days (aiming for 2-4 weeks) at the discretion of the principal investigator (PI).\n* For patients \\> 18 years old, Karnofsky score ≥ 70%. For patients =\\\u003C 18 years old, Lansky score ≥ 50%.\n* Calculated creatinine clearance \\> 70 ml\u002Fmin.\n* Bilirubin \\\u003C 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n* Alanine transaminase (ALT) \\\u003C 3 x upper limit of normal (ULN).\n* For patients \\> 18 years old, pulmonary function (spirometry and corrected diffusing capacity for carbon monoxide \\[DLCO\\]) \\> 60% predicted. For patients =\\\u003C 18 years old, or any patient unable to perform pulmonary function tests, O2 saturation \\> 92% on room air.\n* Left ventricular ejection fraction \\> 50%.\n* Albumin \\> 3.0 g\u002FdL.\n* For patients \\> 18 years old, Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) =\\\u003C 5.\n* UCB units will be selected according to current umbilical cord blood graft selection algorithm. One or two UCB units may be used to achieve the required cell dose.\n* The UCB graft is matched at 4-6 HLA-A, B, DRB1 antigens with the recipient. This may include 0-2 antigen mismatches at the A or B or DRB1 loci. Unit selection based on cryopreserved nucleated cell dose and HLA-A, B, DRB1 using intermediate resolution A, B antigen and DRB1 allele typing.\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients persistent with central nervous system (CNS) involvement in cerebrospinal fluid (CSF) or CNS imaging at time of screening0\n* Prior checkpoint inhibitors\u002F blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy total body irradiation (TBI) in the opinion of radiation oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Inadequate performance status\u002F organ function.\n* Pregnancy or breast feeding.\n* Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.","65 Years",{"count":147,"type":20},54,[87],"This phase II trial studies how well giving an umbilical cord blood transplant together with cyclophosphamide, fludarabine, and total-body irradiation (TBI) works in treating patients with hematologic diseases. Giving chemotherapy, such as cyclophosphamide, fludarabine and thiotepa, and TBI before a donor cord blood transplant (CBT) helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after transplant may stop this from happening in patients with high-risk hematologic diseases.",[92,93,26,28,151,98,27,105,152,153],"Hematopoietic and Lymphatic System Neoplasm","Non-Hodgkin Lymphoma","Chronic Myeloid Leukemia, BCR-ABL1 Positive","2026-01-20",{"date":156,"type":35},"2026-01-22",{"date":158,"type":35},"2024-07-23",{"date":160,"type":20},"2032-10-31",{"name":114,"class":42}]