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

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.

Conditions

• Blastic Plasmacytoid Dendritic Cell Neoplasm

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Cytarabine

Given IT or IV

DRUG

Dexamethasone

Given PO or IV

DRUG

Doxorubicin

Given IV

DRUG

Mercaptopurine

Given PO

DRUG

Methotrexate

Given IT, IV, or PO

DRUG

Methylprednisolone

Given IV

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

BIOLOGICAL

Tagraxofusp-erzs

Given IV

DRUG

Venetoclax

Given PO

DRUG

Vincristine

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Naveen Pemmaraju · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-29

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations