CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 82 enrolled
Drug / intervention
Tagraxofusp Injectiondrug
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.

Search/NCT02268253
NCT02268253Phase 2Completed

Tagraxofusp (SL-401) in Patients With Chronic Myelomonocytic Leukemia (CMML)

Stemline Therapeutics, Inc.·interventional·Posted Oct 20, 2014·Updated Jan 6, 2025

In Brief

A Phase 2 clinical trial evaluating Tagraxofusp Injection for Myelofibrosis and Chronic Myelomonocytic Leukemia. Completed, enrolled 82 participants across 24 sites in 2 countries.

Detailed Summary

This multicenter, multi-arm trial evaluated the safety and efficacy of tagraxofusp, a cell division cycle protein 123 homolog-targeted therapy, in participants with either CMML or MF. There were 2 CMML cohorts, 1 enrolled participant with CMML (CMML-1 or CMML-2) who were refractory/resistant or intolerant to hypomethylating agents (HMA), hydroxyurea (HU), or intensive chemotherapy and 1 enrolled treatment-naive participants with CMML (CMML-1 or CMML-2) with molecular features associated with poor prognosis. The MF cohort enrolled participants who were resistant/refractory or intolerant to approved Janus kinase (JAK) therapy (JAK1/JAK2 or JAK2).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 20, 2014
Enrollment StartFeb 10, 2016
Primary CompletionMar 27, 2023
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 11.7 years ago

Interventions

Tagraxofusp Injectiondrug

Tagraxofusp was administered as a 15-minute intravenous infusion once daily for the first 3 consecutive days of each dosing cycle.