Actively Recruiting
Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
Led by M.D. Anderson Cancer Center · Updated on 2026-04-14
40
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with newly diagnosed or relapsed/refractory blastic plasmacytoid dendritic cell neoplasm confirmed by 2016 WHO criteria
- Frontline patients may have had emergency chemotherapy or one prior cycle of SL-401 or other BPDCN therapy
- Relapsed/refractory patients must have had at least one prior therapy cycle
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Adequate organ function including albumin 63.2 g/dL, serum creatinine <1.5 times the upper limit of normal, AST and ALT <2.5 times the upper limit of normal, and total bilirubin <1.5 times the upper limit of normal (with exceptions for Gilbert's disease or BPDCN-related elevations)
- Ability to understand and willing to sign informed consent
- Able to follow study visit schedule and protocol requirements including survival follow-up
- Women of child-bearing potential and men must agree to use effective contraception during and for 2 months after treatment; males must avoid sperm donation during and for 8 weeks after last SL-401 dose
- Left ventricular ejection fraction above institutional lower limit of normal by MUGA scan or echocardiogram within 30 days before treatment start
You will not qualify if you...
- Pregnant or breastfeeding individuals
- Known active hepatitis B or C infection or HIV seropositivity
- Major surgery or radiation therapy within 14 days before first study dose
- Symptomatic or untreated leptomeningeal disease or spinal cord compression
- Active severe heart disease (NYHA class 3 or 4), unstable angina, stroke, or heart attack within last 6 months
- Conditions causing malabsorption or preventing oral medication intake
- Other serious medical or psychiatric conditions or lab abnormalities that increase risk or interfere with study participation or results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Naveen Pemmaraju
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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