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Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia
NCT02113982 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02113982
The ClinicalTrials.gov registry entry for NCT02113982 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 138 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stemline Therapeutics, which has 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02113982 reports 9 study locations spanning 8 distinct geographic areas — top geographies include New York, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02113982?
The interventions under investigation include: Tagraxofusp (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02113982?
This trial is sponsored by Stemline Therapeutics, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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