At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 138 enrolled
Drug / intervention
Tagraxofuspdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Tagraxofusp in Patients With Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
In Brief
A Phase 2 clinical trial evaluating Tagraxofusp for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) and Acute Myeloid Leukemia (AML). Completed, enrolled 138 participants across 9 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsThe Leukemia and Lymphoma Society
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartSep 2014
Primary CompletionFeb 2020
Study CompletionMar 2020
TodayJul 2026
First PostedApr 15, 2014
Enrollment StartSep 1, 2014
Primary CompletionFeb 1, 2020
Study CompletionMar 12, 2020
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 12.2 years ago
Interventions
Tagraxofuspdrug