About this trial
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.
Eligibility criteria
Qualifiers
Treatment naïve or relapsed refractory patients with histologically confirmed diagnosis of blastic plasmacytoid dendritic cell neoplasm (BPDCN) per 2016 WHO criteria
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.
Disqualifiers
Participants is pregnant or breastfeeding
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
Trial design
Treatments tested in this trial
- Cyclophosphamide
- Cytarabine
- Dexamethasone
- Doxorubicin
- Mercaptopurine
- Methotrexate
- Methylprednisolone
- Prednisone
- Rituximab
- Tagraxofusp-erzs
- Venetoclax
- Vincristine
Treatment groups
Sponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator