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This study evaluates the drug Ruxolitinib Phosphate in patients with Chronic Neutrophilic Leukemia (CNL) or atypical Chronic Myeloid Leukemia (aCML). It included newly or previously diagnosed patients who had a bone marrow biopsy. It was a Phase 2 study and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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