Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF)

Completed · Phase 1/Phase 2

Conditions studied: Myelofibrosis, Chronic Myelomonocytic Leukemia

In brief

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).

Key facts

Study ID

NCT02268253

Run by

Stemline Therapeutics, Inc.

People needed

82

Starts

2016-02-10

Expected to finish

2023-03-27

Last updated by the study team

2025-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• University of California, San Francisco — Clovis, California, United States
• City of Hope — Duarte, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• Stanford Cancer Institute — Stanford, California, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• Georgia Cancer Center at Augusta University — Augusta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana Blood and Bone Marrow Transplantation — Indianapolis, Indiana, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Dana Farber Cancer Institute (DFCI) — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• John Theurer Cancer Center — Hackensack, New Jersey, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Weill Cornell Medical Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• University of Alberta — Edmonton, Alberta, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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