Anemia Clinical Trial
Official title:
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
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.
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.
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