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Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01732445•Mayo Clinic

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histological confirmation of primary myelofibrosis (MF), post polycythemia vera (PV) or post essential thrombocythemia (ET) myelofibrosis (intermediate 1, intermediate II or high risk) requiring medical therapy
•Anemia is required for trial entry (defined as hemoglobin \< 10g/dL or transfusion dependent \[having needed a transfusion anytime in the past 6 months\])
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at study entry
•Absolute neutrophil count (ANC) \>= 1000/uL
•Platelet count \>= 50,000/uL
•Serum creatinine =\< 1.5 x the upper limit of normal (ULN)
•Total bilirubin =\< 1.5 x ULN; if total bilirubin is \> 1.5 x ULN, a direct bilirubin should be performed and must be \< 1.5mg/dL
•Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x ULN; higher values (i.e., =\< 5 x ULN) are allowed if clinically compatible with hepatic extramedullary hematopoiesis
•Life expectancy of \>= 6 months
•Patient able to provide voluntary written informed consent to participate
+2 more criteria

Exclusion Criteria

•Any chemotherapy (e.g., hydroxyurea), immunomodulatory drug therapy (e.g., thalidomide, interferon-alpha), immunosuppressive therapy, corticosteroids \> 10 mg/day prednisone or equivalent, or growth factor treatment (e.g., erythropoietin), hormones (e.g., androgens, danazol) =\< 14 days prior to registration; note: patients who are on ruxolitinib may continue on without a 14 day wash out at the treating physician's discretion
•Major surgery =\< 28 days or radiation =\< 6 months prior to registration
•Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
•Active acute infection requiring antibiotics
•Uncontrolled congestive heart failure (New York Heart Association classification 3 or 4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass, graft surgery, transient ischemic attack, or pulmonary embolism within 3 months prior to registration
•Participation in any study of an investigational agent (drug, biologic, device) =\< 30 days, unless during non-treatment phase
•Any of the following:
•* Pregnant women
•* Nursing women
•* Men or women of childbearing potential who are unwilling to employ adequate contraception
+24 more criteria

Locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Tisch Cancer Center

New York, New York, United States

Key Dates

Start Date

April 1, 2013

Primary Completion Date

July 14, 2016

Completion Date

August 10, 2017

Last Updated

October 18, 2017

Enrollment

ACTUAL participants

Conditions

AnemiaPrimary MyelofibrosisSecondary Myelofibrosis

Interventions

ruxolitinib phosphate

DRUG

danazol

DRUG

quality-of-life assessment

OTHER

questionnaire administration

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 18, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis

Inclusion Criteria

Exclusion Criteria

Natural History of Acquired and Inherited Bone Marrow Failure Syndromes

Haplo-identical Transplantation for Severe Aplastic Anemia, Hypo-plastic MDS and PNH Using Peripheral Blood Stem Cells and Post-transplant Cyclophosphamide for GVHD Prophylaxis

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

Guideline Adherence for Preoperative Anemia Management in a PAC

Revolade Tablets Specified Drug-use Survey

National Longitudinal Cohort of Hematological Diseases