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

Myelofibrosis Clinical Trial

Official title:

Open-Label Roll-Over Study to Assess the Long-Term Safety and Efficacy of Ruxolitinib in Subjects With Myelofibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784496
• Other study ID #: 2015-0872
• Secondary ID: NCI-2016-0118120
• Status: Completed
• Phase: Phase 2
• Start date: September 29, 2016
• Est. completion date: January 23, 2024

Study information

• Verified date: January 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 23, 2024
• Est. primary completion date: January 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Criteria:

1. none

Related Conditions & MeSH terms

• Myelofibrosis
• Primary Myelofibrosis

Intervention

Other:
• Long-term Follow-up
Undergo follow-up assessment
• Quality-of-Life Assessment
Ancillary studies

Drug:
• Ruxolitinib
Given PO

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events	Safety data of the patients will be summarized using descriptive statistics such as mean, standard deviation, median and range. Will follow standard reporting guidelines for adverse events. Safety data will be summarized by category, severity and frequency.	Up to 3 years

External Links

•   MD Anderson Cancer Center