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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: Completed Phase 1 study of Chronic Myelomonocytic Leukemia and Myelofibrosis, sponsored by Stemline Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
During Stage 1, DLT was defined as any of the following occurring during the first cycle of therapy: any treatment-emergent Grade 4 transaminase or creatine phosphokinase (CPK) elevation (confirmed within 24 hours of initial identification), regardless of duration or relationship to SL-401; any Grade ≥3 non-hematologic toxicity (unrelated to underlying MPN), with the exception of Grade 3 laboratory toxicities that resolve to Grade ≤1 or baseline ≤28 days after the last infusion of SL-401, or the
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 |
What the finished NCT02268253 record still lists
NCT02268253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, roughly in line with the 88-participant average among 73 other Chronic Myelomonocytic Leukemia trials with a reported enrollment target.
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
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Where NCT02268253's enrollment target sits among peer trials
82 19th of 73 higher than 55 of 73 other Chronic Myelomonocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Myelomonocytic Leukemia 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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