M.D. Anderson Cancer Center
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.
PRIMARY OBJECTIVE: I. To evaluate progression-free survival (PFS) at 12 months of venetoclax (VEN) in combination with chemotherapy and SL-401 (tagraxofusp \[TAG\]) in patients with newly diagnosed blastic plasmacytoid dendritic cell neoplasm (BPDCN). SECONDARY OBJECTIVES: I. To determine the safety of the SL-401 in combination with VEN and in combination with chemotherapy in patients with newly diagnosed BPDCN by toxicity and futility monitoring. II. To determine the efficacy by measurement of progression free survival (PFS), overall response rate (ORR): complete response (CR) and complet…
Inclusion Criteria: 1. Treatment naïve or relapsed refractory patients with histologically confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) per 2016 WHO criteria 2. Front line participants may have received emergent chemotherapy prior to study enrollment: 1. One prior cycle of SL-401, or other BPDCN-directed therapy, will be allowed prior to entering the study. 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. 3. Relapsed/refractory participants may have receive…
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