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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: Completed Phase 1 study of Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN), sponsored by Stemline Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maximum tolerated dose (MTD) in both patients with BPDCN and AML. MTD defined as the highest dose level where less than 2/3 or 2/6 patients experienced a DLT
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2014-09 |
| Est. Completion | 2020-03-12 |
| Phase | Phase 1 |
What the finished NCT02113982 record still lists
NCT02113982 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 141-participant average among 29 other Acute Myeloid Leukemia (AML) trials with a reported enrollment target.
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 lists 9 locations in 8 states (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.
Learn More About Clinical Trials
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Where NCT02113982's enrollment target sits among peer trials
138 8th of 29 higher than 22 of 29 other Acute Myeloid Leukemia (AML) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia (AML) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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