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NCT02268253 · ClinicalTrials.gov registry record · Phase 1
Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF)
A Phase 1 study of Chronic Myelomonocytic Leukemia and Myelofibrosis, sponsored by Stemline Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
- 20
- Study locations
NCT02268253 is a Phase 1 study of Chronic Myelomonocytic Leukemia and Myelofibrosis that has completed, run by Stemline Therapeutics. The registered enrollment target is 82 participants, roughly in line with the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target. The trial reports 20 study locations across 14 states.
The verdict
NCT02268253, a Phase 1 study of Chronic Myelomonocytic Leukemia and Myelofibrosis, has completed, sponsored by Stemline Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
- 20
- Study locations
Study 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).
Conditions Studied
Interventions
- DRUG Tagraxofusp Injection
Study Locations (20)
California
- University of California, San Francisco - Clovis
- City of Hope - Duarte
- University of California, Los Angeles - Los Angeles
- Stanford Cancer Institute - Stanford
Massachusetts
- Dana Farber Cancer Institute (DFCI) - Boston
- Massachusetts General Hospital - Boston
New York
- Roswell Park Cancer Institute - Buffalo
- Weill Cornell Medical Center - New York
Ohio
- Cleveland Clinic Foundation - Cleveland
- The Ohio State University - Columbus
Florida
- Mayo Clinic Florida - Jacksonville
Georgia
- Georgia Cancer Center at Augusta University - Augusta
Illinois
- Rush University Medical Center - Chicago
Indiana
- Indiana Blood and Bone Marrow Transplantation - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2016-02-10 |
| Est. Completion | 2023-03-27 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02268253
The ClinicalTrials.gov registry entry for NCT02268253 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 88-participant average among 73 other Chronic Myelomonocytic Leukemia 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 Chronic Myelomonocytic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Tagraxofusp Injection is the first listed.
NCT02268253 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT02268253 about?
NCT02268253 is a clinical study titled "Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF)". 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 into...
What is the current status of trial NCT02268253?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2016-02-10. Estimated completion is 2023-03-27.
What conditions does trial NCT02268253 study?
This clinical trial studies the following conditions: Chronic Myelomonocytic Leukemia, Myelofibrosis.
What interventions are being tested in trial NCT02268253?
The interventions under investigation include: Tagraxofusp Injection (DRUG).
Who is sponsoring clinical trial NCT02268253?
This trial is sponsored by Stemline Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02268253 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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