RecruitingPhase 2NCT04216524

Venetoclax, SL-401, and Chemotherapy for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm

Phase 2 Clinical Trial for Comprehensive Treatment Program for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Tagraxofusp (SL-401) in Combination With HCVAD/Mini-CVD and VENETOCLAX


Sponsor

M.D. Anderson Cancer Center

Enrollment

40 participants

Start Date

May 29, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of venetoclax (a targeted drug), SL-401 (a targeted therapy), and chemotherapy for patients with a rare blood cancer called blastic plasmacytoid dendritic cell neoplasm (BPDCN), to see if this combination can achieve better remission rates. **You may be eligible if...** - You are 18 or older - You have BPDCN (a rare blood cancer) confirmed by 2016 WHO criteria - You may be newly diagnosed or have relapsed/refractory disease - Your overall health is adequate (ECOG 0–2) - Your organ function (albumin, etc.) meets the study requirements **You may NOT be eligible if...** - You have not been diagnosed with BPDCN - Your organ function is too impaired for treatment - You do not meet the performance status requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCyclophosphamide

Given IV

DRUGCytarabine

Given IT or IV

DRUGDexamethasone

Given PO or IV

DRUGDoxorubicin

Given IV

DRUGMercaptopurine

Given PO

DRUGMethotrexate

Given IT, IV, or PO

DRUGMethylprednisolone

Given IV

DRUGPrednisone

Given PO

BIOLOGICALRituximab

Given IV

BIOLOGICALTagraxofusp-erzs

Given IV

DRUGVenetoclax

Given PO

DRUGVincristine

Given IV


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04216524


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