NCT01732445

Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis

A Phase 2 Pilot Trial of Ruxolitinib Combined With Danazol for Patients With Primary Myelofibrosis (MF), Post Essential Thrombocythemia-Myelofibrosis (Post ET) and Post Polycythemia Vera Myelofibrosis (PV MF) Suffering From Anemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in treating anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause the body to make more red blood cells. They are used to treat anemia in patients with myelofibrosis.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy (best overall response) of ruxolitinib (ruxolitinib phosphate) and danazol in patients with myelofibrosis suffering from anemia. SECONDARY OBJECTIVES: I. To evaluate the overall survival of patients with myelofibrosis suffering from anemia initiating ruxolitinib and danazol. II. To evaluate the adverse event profile of ruxolitinib and danazol in patients with myelofibrosis suffering from anemia. TERTIARY OBJECTIVES: I. To evaluate quality of life (QOL) and patient-reported symptoms using the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) and European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) with ruxolitinib and danazol for patients with myelofibrosis suffering from anemia. OUTLINE: Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) and danazol PO thrice daily (TID) on days 1-56. Treatment repeats every 56 days for 6 courses in the absence of disease progression or unacceptable toxicity. At the treating physician's discretion, patients may continue treatment past 6 courses if they are without disease progression. After completion of study treatment, patients are followed up every 6 months for 2 years.

Conditions

• Anemia
• Primary Myelofibrosis
• Secondary Myelofibrosis

Interventions

Type	Name	Description
DRUG	ruxolitinib phosphate	Given PO
DRUG	danazol	Given PO
OTHER	quality-of-life assessment	Ancillary studies
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-07-14
• Completion: 2017-08-10
• First posted: 2012-11-22
• Last updated: 2017-10-18
• Results posted: 2017-10-18

Locations

2 sites across 1 country: United States