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NCT02113982 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), sponsored by Stemline Therapeutics.

Completed
Registry status
Phase 1
Development phase
138
Enrollment target
9
Study locations

NCT02113982 is a Phase 1 study of Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) that has completed, run by Stemline Therapeutics. The registered enrollment target is 138 participants, roughly in line with the 141-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target. The trial reports 9 study locations across 8 states.

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The verdict

NCT02113982, a Phase 1 study of Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), has completed, sponsored by Stemline Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
138 participants
Enrollment target
9
Study locations

Study 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.

Conditions Studied

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

Interventions

  • DRUG Tagraxofusp

Study Locations (9)

New York

  • Roswell Park Cancer Institute - Buffalo
  • Columbia University Medical Center - New York

California

  • City of Hope National Medical Center - Duarte

Florida

  • H. Lee Moffiitt Cancer Center & Research Institute - Tampa

Massachusetts

  • Dana Farber Cancer Institute - Boston

North Carolina

  • Duke University Medical Center - Durham

Ohio

  • Ohio State University - Columbus

Pennsylvania

  • University of Pittsburgh Medical Center Presbyterian Shady Side - Pittsburgh

Texas

  • MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 138 participants
Start Date 2014-09
Est. Completion 2020-03-12
Phase Phase 1

Sponsor

Stemline Therapeutics

17 total trials

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What the Registry Record Tells You About NCT02113982

The ClinicalTrials.gov registry entry for NCT02113982 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 141-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target. The listed sponsor is Stemline Therapeutics, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acute Myeloid Leukemia (AML) appearing as the primary indexed condition, and to 1 intervention - of which Tagraxofusp is the first listed.

NCT02113982 reports 9 study locations spanning 8 distinct geographic areas - top geographies include New York, California, Florida.

Frequently Asked Questions

What is clinical trial NCT02113982 about?

NCT02113982 is a clinical study titled "Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia". 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.

What is the current status of trial NCT02113982?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 138 participants. The study started on 2014-09. Estimated completion is 2020-03-12.

What conditions does trial NCT02113982 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia (AML), Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN).

What interventions are being tested in trial NCT02113982?

The interventions under investigation include: Tagraxofusp (DRUG).

Who is sponsoring clinical trial NCT02113982?

This trial is sponsored by Stemline Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02113982 being conducted?

This trial has 9 study locations across California, Florida, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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