Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT01732445
Phase
PHASE2
Status
Completed

Conditions

  • Anemia
  • Primary Myelofibrosis
  • Secondary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ruxolitinib phosphate — DRUG
    Given PO
  • danazol — DRUG
    Given PO
  • quality-of-life assessment — OTHER
    Ancillary studies
  • questionnaire administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Apr 30, 2013
Status verified
May 2017
Primary completion
Jul 14, 2016
Completion
Aug 10, 2017

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Supportive care (ruxolitinib phosphate and danazol)
    Patients receive ruxolitinib phosphate PO BID and danazol PO 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.

Primary Outcome Measure

Best Overall Response Rate as Determined by International Working Group Criteria [ Time Frame: Up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
Tisch Cancer CenterNew YorkNew York10029-

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By research site
Mayo Clinic in Arizona· Scottsdale, AZTisch Cancer Center· New York, NY

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