Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Cyclophosphamide
DrugGiven IV
Cytarabine
DrugGiven IT or IV
Dexamethasone
DrugGiven PO or IV
Doxorubicin
DrugGiven IV
Mercaptopurine
DrugGiven PO
Methotrexate
DrugGiven IT, IV, or PO
Methylprednisolone
DrugGiven IV
Prednisone
DrugGiven PO
Rituximab
Biological/VaccineGiven IV
Tagraxofusp-erzs
Biological/VaccineGiven IV
Venetoclax
DrugGiven PO
Vincristine
DrugGiven IV
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Treatment (SL-401, venetoclax, chemotherapy)Experimental treatment 12 interventions
Trial outcomes
Primary outcomes
1
Progression free survival (PFS)
The median PFS time will be estimated by Bayesian posterior estimates. Estimated using the Kaplan-Meier method.
Time frame
Up to 6 years2
Incidence of adverse events
Will be reported by type, frequency and severity. Highest toxicity grades per patient per course will be tabulated for selected adverse events and laboratory measurements.
Time frame
Up to 6 years3
Overall response rate
Overall response rate along with complete remission and complete remission with incomplete hematologic recovery will be estimated along with 95% confidence interval.
Time frame
Up to 6 years4
Rate of stem cell transplant
The response rate will be compared between subgroups (e.g. minimal residual disease negativity, etc.) by Fisher's exact test, and Wilcoxon rank test will be used to compare the patient clinical information (e.g., protein expression) between subgroups such as response and non-response.
Time frame
Up to 6 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov