Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia

Not Recruiting

Trial ID: NCT02092324

Purpose

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.

Official Title

Prospective Evaluation of Ruxolitinib Efficacy for CNL/aCML Patients With Mutation of CSF3R

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

Intervention(s):

drug: Ruxolitinib Phosphate

other: Laboratory Biomarker Analysis

other: Quality-of-Life Assessment

other: Questionnaire Administration

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Isabel Reyes
650-725-4047

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