Phase 2
N=8
Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis
Myelofibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02784496 ↗Enrolled (actual)
8
Serious AEs
75.0%
Results posted
Aug 2025
Primary outcome: Primary: Most Common Treatment Related Adverse Events — 1; 1; 2; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Long-term Follow-up (Other); Quality-of-Life Assessment (Other); Ruxolitinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Most Common Treatment Related Adverse Events |
1; 1; 2; 1 | — |
Summary
This phase II trial studies the long-term side effects of ruxolitinib in treating patients with myelofibrosis. Collecting data about the long-term safety and tolerability of ruxolitinib may better help future patients with myelofibrosis.
Eligibility Criteria
Inclusion Criteria
- Currently enrolled in study 2007-0169 and benefiting from therapy as determined by treating physician
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment of this study
- Ability and agreement to attend protocol-specified visits at the study site
- Able to comprehend and willing to sign the informed consent form
- Negative pregnancy test in females of childbearing potential; male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose; acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner's vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap; female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test 7 days before first study treatment
Exclusion Criteria
- none
Data sourced from ClinicalTrials.gov (NCT02784496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.