Ph II Study of Azacitidine in Myelofibrosis
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis
Intervention: Azacitidine
Intervention description: 75 mg/m^2 subcutaneous daily for 7 days (every 4 week cycle)
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelofibrosis; MF; Leukemia; Azacitidine; Vidaza

Summary:

      The goal of this clinical research study is to learn if azacitidine can help to control MF.
      The safety of azacitidine in patients with Myelofibrosis (MF) will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of MF requiring therapy, including those previously treated and relapsed or
             refractory, or if newly diagnosed, with intermediate or high risk according to Lille
             scoring system (adverse prognostic factors are: Hemoglobin (Hb) < 10 g/dl, White Blood
             Cell (WBC) < 4 or > 30 x 10*9/L; risk group: 0 = low, 1 = intermediate, 2 = high).

          -  Performance 0-2 Eastern Cooperative Oncology Group (ECOG).

          -  Signed informed consent.

          -  Patients must have been off chemotherapy for 2 weeks prior to entering this study and
             have recovered from the toxic effects (grade 0-1) of that therapy. Patients are
             allowed to be on anagrelide and hydroxyurea to control high platelet and WBC counts
             for their safety.

          -  Serum bilirubin levels </= 1.5 times the upper limit of the normal range for the
             laboratory Upper Limit of of Normal(ULN). Higher levels are acceptable if these can be
             attributed to active hemolysis or ineffective erythropoiesis.

          -  Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
             serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels </=
             2 x ULN.

          -  Serum creatinine levels </= 1.5 x ULN; unless related to the MF, as judged by treating
             physicians.

          -  Women of childbearing potential must have a negative serum pregnancy test prior to
             azacitidine treatment and should be advised to avoid becoming pregnant. Men must be
             advised to not father a child while receiving treatment with azacitidine. Both women
             of childbearing potential and men must practice effective methods of contraception
             (those generally accepted as standard of care measures).

          -  Age >/= 18.

        Exclusion Criteria:

          -  Nursing and pregnant females. Should a woman become pregnant or suspect she is
             pregnant while participating in this study, she should inform her treating physician
             immediately.

          -  Uncontrolled intercurrent illness including, but not limited to, uncontrolled active
             infection, symptomatic congestive heart failure, unstable angina pectoris, or
             psychiatric illness/social situations that would limit compliance with study
             requirements.

          -  Known or suspected hypersensitivity to azacitidine or mannitol.