OncRef

Clinical Trial: NCT02113982

Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Stemline Therapeutics, Inc.
Information Provided By:Stemline Therapeutics, Inc.
Last Update Posted:2024-08-01

Study Overview

Brief Summary

This is a 4-stage, non-randomized, open-label, dose escalation and expansion, multicenter study. A cycle of therapy is 21 days. Stage 1 was a dose-escalation stage. During Stages 2-4, patients are treated at the MTD or maximum tested dose at which multiple DLTs are not observed during Stage 1.

Official Title

Tagraxofusp in Patients With Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Conditions

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), Acute Myeloid Leukemia (AML)

Intervention / Treatment

  • Drug: Tagraxofusp

Other Study ID Numbers

  • STML-401-0114

Start Date

2014-09

Primary Completion Date (Actual)

2020-02-01

Study Completion Date (Actual)

2020-03-12

Enrollment (Actual)

138

Study Type

Interventional

Phase

Phase 1, Phase 2