Overview

Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis

Status:
Active, not recruiting
Trial end date:
2024-09-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Incyte Corporation
National Cancer Institute (NCI)
Treatments:
Janus Kinase Inhibitors
Criteria
Inclusion Criteria:

1. Currently enrolled in study 2007-0169 and benefiting from therapy as determined by
treating physician

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at
enrollment of this study

3. Ability and agreement to attend protocol-specified visits at the study site

4. Able to comprehend and willing to sign the informed consent form

5. 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:

1. none