Long-Term Side Effects of Ruxolitinib in Treating Patients With Myelofibrosis
August 12, 2025 updated by: M.D. Anderson Cancer Center
Open-Label Roll-Over Study to Assess the Long-Term Safety and Efficacy of Ruxolitinib in Subjects With Myelofibrosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To collect long term safety and tolerability data in patients with myelofibrosis previously treated with ruxolitinib on protocol 2007-0169.
OUTLINE:
Patients continue to receive ruxolitinib orally (PO) once daily (QD) or twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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:
1. none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment (ruxolitinib, follow-up)
Patients continue to receive ruxolitinib PO QD or BID.
Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo follow-up assessment for safety over 10 minutes every 3 cycles.
|
Ancillary studies
Other Names:
Given PO
Other Names:
Undergo follow-up assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Most Common Treatment Related Adverse Events
Time Frame: to the date of failure or death from any cause, Up to 7 years, 3 months and 24 days
|
A review of the most common adverse events related to study medication will be performed.
Will follow standard reporting guidelines for adverse events.
Safety data will be summarized by the number of participants affected.
|
to the date of failure or death from any cause, Up to 7 years, 3 months and 24 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Prithviraj Bose, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2016
Primary Completion (Actual)
January 23, 2024
Study Completion (Actual)
January 23, 2024
Study Registration Dates
First Submitted
May 20, 2016
First Submitted That Met QC Criteria
May 26, 2016
First Posted (Estimated)
May 27, 2016
Study Record Updates
Last Update Posted (Estimated)
August 29, 2025
Last Update Submitted That Met QC Criteria
August 12, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0872 (Other Identifier: M D Anderson Cancer Center)
- NCI-2016-01181 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.