Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia
Condition: Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Chronic Neutrophilic Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Leukemia, Neutrophilic, Chronic
Intervention: Laboratory Biomarker Analysis; Quality-of-Life Assessment; Questionnaire Administration; Ruxolitinib Phosphate
Intervention description: Correlative studies; Ancillary studies; Ancillary studies; Given PO
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well ruxolitinib phosphate works in treating patients with
      chronic neutrophilic leukemia (CNL) or atypical chronic myeloid leukemia (aCML). Ruxolitinib
      phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for
      cells to reproduce. This trial also studies the genetic makeup of patients. Certain genes in
      cancer cells may determine how the cancer grows or spreads and how it may respond to
      different drugs. Studying how the genes associated with CNL and aCML respond to the study
      drug may help doctors learn more about CNL and aCML and improve the treatment for these
      diseases.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be newly diagnosed or previously diagnosed with CNL or aCML; all
             patients must have a bone marrow biopsy completed during the screening or baseline
             period if one has not been done within 90 days of day 1, cycle one

          -  Subjects must have platelet count greater than 25,000 per microliter at baseline and
             at the start of study (day 1, cycle 1) visit

          -  Subjects must be able to discontinue any drug treatment aimed at lowering disease
             burden in CNL or aCML; subjects should discontinue hydroxyurea to treat underlying CNL
             or aCML disease no later than day -7 (one week before starting ruxolitinib); for drugs
             that have more long-lasting effects on the marrow, such as thalidomide and its
             analogs, and interferon, subjects should discontinue these no later than day -28

          -  Subjects must be willing to accept/continue transfusions to treat low hemoglobin
             levels

          -  Subjects must have a life expectancy of > 6 months

        Exclusion Criteria:

          -  Subjects unable to review and sign informed consent form

          -  Females who are pregnant or breastfeeding, and males and females who cannot comply
             with requirements to avoid fathering a child or becoming pregnant

          -  Subjects with known diagnosis of human immunodeficiency virus (HIV) or chronic active
             Hepatitis B or C; viral testing is not required; subjects with a history of Hepatitis
             B and/or C are allowed on trial if the virus is undetected at the time of enrollment

          -  Subjects with inadequate liver (alanine aminotransferase [ALT]/serum glutamate
             pyruvate transaminase [SGPT] above 4 X upper limit of normal [ULN] or direct bilirubin
             4 X ULN AND the lab abnormalities are felt to be due to underlying liver dysfunction)

          -  Subjects with end stage renal function (creatinine clearance [CrCl] < 15 mL/min or
             glomerular filtration rate [GFR] <15 mL/min) regardless of whether hemodialysis is
             required

          -  Subjects with clinically serious infections requiring ongoing antibiotic therapy

          -  Subjects with severe (immediately life threatening) and recent (occurring within the
             last 3 months) cardiac dysfunction, pulmonary dysfunction, esophageal variceal
             bleeding, hemorrhagic strokes, or intracranial hemorrhage are not eligible for study
             participation

          -  Subjects requiring therapeutic doses of anticoagulation or anti-platelet therapies
             (aspirin above 81 mg daily, Plavix or similar agents) AND platelet counts are below
             50,000 on two different laboratory evaluations, separated by minimum of two weeks

          -  Taking investigational or commercial agents or therapies with the intent to treat the
             subject's malignancy other than those therapies permitted

          -  Subjects with invasive malignancy over the previous 2 years except treated early stage
             carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix,
             and completely resected papillary thyroid and follicular thyroid cancers

          -  Previous allergic reactions to janus kinase (JAK) inhibitors or excipients

          -  Prior therapy with ruxolitinib or other JAK inhibitors

          -  Subjects who have had major surgery within 4 weeks prior to entering the study

          -  Subjects who are anticipated to receive a transplant within the first 6 months of
             treatment on trial