| Last Verified: | April/30/2020 |
| First Submitted: | March/18/2020 |
| Estimated Enrollment Submitted: | March/18/2020 |
| First Posted: | March/22/2020 |
| Last Update Submitted: | May/27/2020 |
| Last Update Posted: | May/28/2020 |
| Actual Study Start Date: | March/26/2020 |
| Estimated Primary Completion Date: | August/30/2021 |
| Estimated Study Completion Date: | August/30/2021 |
| Study Type: | Interventional |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
| Masking: | None (Open Label) |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Treatment (tagraxofusp-erzs) Within day 45 and 120 after stem cell transplant, patients receive tagraxofusp-erzs IV over 15 minutes on days 1-3 of cycles 1-4 and days 1-2 of subsequent cycles. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. | Biological: Treatment (tagraxofusp-erzs) Given IV |
| Ages Eligible for Study: | 2 Years to 2 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Criteria: | Inclusion Criteria: - Eligible patients will be aged >= 18 years. Pediatric patients age 2 years and older will be considered on a case by case basis. - Diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) according to World Health Organization (WHO) classification or confirmed by hematopathology - The patients must be in partial response or better - > 30 days post-transplant without active or chronic infections - Karnofsky performance status >= 60%; Lansky >= 60 - Left ventricular ejection fraction (LVEF) >= institutional lower limit of normal by multigated acquisition (MUGA) scan or echocardiogram within 30 days of first protocol treatment - Diffusion capacity of the lung for carbon monoxide (DLCO) > 40% of predicted value (corrected for hemoglobin) within 3 months of registration - Forced expiratory volume in 1 second (FEV1) > 40% of predicted value within 3 months of registration - Forced vital capacity (FVC) > 40% of predicted value within 3 months of registration - Serum creatinine =< 1.5 mg/dL (133 mmol/L) - Serum albumin >= 3.2 g/dL (or >= 32 g/L) without IV albumin within the previous 72 hours - Bilirubin =< 1.5 x the upper limit of normal ([ULN] except patients with Gilbert syndrome in whom bilirubin level of > 1.5 x ULN will be allowed) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times ULN - Hemoglobin >= 8 g/dL with or without transfusion in the last 7 days - Absolute neutrophil count (ANC) >= 1000 without granulocyte colony stimulating factor (GCSF) or granulocyte-macrophage colony-stimulating factor (GMCSF) in the last 2 weeks prior to screening - Platelets >= 50,000micro/mL - For allo-HCT, no >= grade 2 visceral (gut or liver) acute graft versus host disease (GVHD) and no >= grade 3 or any other acute GVHD (patients with chronic GVHD will be allowed at the discretion of the investigator) - Patient agrees to use acceptable contraceptive methods for the duration of time in the study, and to continue to use acceptable contraceptive methods for 2 months after the last tagraxofusp infusion - Woman of child bearing potential (WOCBP) with a negative serum or urine pregnancy test within 14 days of tagraxofusp treatment - Patient or patient's legal representative, parent(s) or guardian able to sign informed consent - The patient can adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment Exclusion Criteria: - The patient has persistent clinically significant non-hematologic toxicities >= grade 2 (excluding alopecia, nausea, and fatigue) - Evidence of central nervous system (CNS) involvement - Uncontrolled and active pulmonary disease - Requirement for oxygen treatment - Receiving chemotherapy, radiotherapy or other anti-cancer therapy within 14 days of first dose of study drug. There must be at least a 6-week interval from the last immunotherapy therapy - Uncontrolled infection - Human immunodeficiency virus (HIV)/hepatitis B and/or C - Any history of invasive malignancy in the last 2 years excluding any malignancy such as cervical cancer or skin cancer (excluding melanoma) that is considered cured at the time of screening - Pregnant or breast-feeding woman - Patient has uncontrolled intercurrent illness or medical/psychiatric condition that would limit compliance with study requirements or that would in the investigator's opinion place the patient at an unacceptably high risk for toxicities - Clinical significant cardiopulmonary disease including uncontrolled or New York Heart Association (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 corrected QT (QTc) > 480 ms |