Phase 3 Study of MK-3543 (Thrombocythemia, Polycythemia Vera, and Myelofibrosis)

Phase 3 Study of MK-3543 (Thrombocythemia, Polycythemia Vera, and Myelofibrosis)

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Purpose of this Study

We are doing this study to find out if continued use of an experimental drug called bomedemstat (the study drug) can provide an extended benefit for people with myeloproliferative neoplasms. We are enrolling people who have been in a previous study using the study drug and received a positive benefit.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with thrombocythemia, polycythemia vera, or myelofibrosis
  • Participated in a previous clinical trial using bomedemstat (participants from the IMG-7289-202/MK-3543-005 study must have received at least 6 months of treatment with the study drug)
  • Do not have a history of noncompliance in a prior bomedemstat study
For more information, contact the study team at erin.murphy@duke.edu.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

You can choose to join this study when you finish your current/previous trial of the study drug. If you are interested in joining, the study doctor will assess your eligibility at the end of your original bomedemstat trial and transition you into this study at its end if you are eligible to continue taking the study drug. You will visit our clinic roughly every 4 weeks while you take the study drug in this trial. You will remain in the study for as long as you and your doctor believe that you are getting a positive benefit.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

No

Study Details

Full Title

A Multicenter, Open-Label, Extension Study Evaluating the Safety and
Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study

Principal Investigator

Lindsay
Rein

Protocol Number

PRO00116787

NCT ID

NCT06351631

Phase

III

Enrollment Status

Pending Open to Enrollment