Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neo… (NCT04216524) | Clinical Trial Compass
RecruitingPhase 2
Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
United States40 participantsStarted 2020-05-29
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Treatment naïve or relapsed refractory patients with histologically confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) per 2016 WHO criteria
✓. Front line participants may have received emergent chemotherapy prior to study enrollment:
✓. One prior cycle of SL-401, or other BPDCN-directed therapy, will be allowed prior to entering the study.
✓. Prior or concomitant doses of ARA-C (cytarabine) or Hydroxyurea are allowed on before or during the study for proliferative disease due to BPDCN.
✓. Relapsed/refractory participants may have received at least one prior cycle of therapy.
✓. Age ≥ 18 years
✓. ECOG performance status 0, 1, or 2 (see APPENDIX B)
. Known active hepatitis B or C infection, or known seropositivity for human immunodeficiency virus (HIV)
✕. Major surgery or radiation therapy within 14 days prior to the first study dose
✕. Symptomatic or untreated leptomeningeal disease or spinal cord compression
✕. Participants with active heart disease (New York Heart Association (NYHA) class 3-4 as assessed by history and physical examination, unstable angina/stroke/myocardial infarction within the last 6 months)
✕. Malabsorption syndrome or other conditions that preclude enteral route of administration
✕. 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/or would make the participants inappropriate for enrollment into this study