NCT02784496

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Myelofibrosis

Interventions

Type	Name	Description
OTHER	Long-term Follow-up	Undergo follow-up assessment
OTHER	Quality-of-Life Assessment	Ancillary studies
DRUG	Ruxolitinib	Given PO

Timeline

• Start date: 2016-09-29
• Primary completion: 2024-01-23
• Completion: 2024-01-23
• First posted: 2016-05-27
• Last updated: 2025-08-29
• Results posted: 2025-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study