Ruxolitinib Phosphate to Treat Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma After Stem Cell Transplant
Condition: Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, T-Cell; Recurrence
Intervention: Laboratory Biomarker Analysis; Ruxolitinib Phosphate
Intervention description: Correlative studies; Given PO
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well ruxolitinib phosphate works in treating patients with
      diffuse large B-cell or peripheral T-cell non-Hodgkin lymphoma that has returned (relapsed)
      or that does not respond to treatment (refractory) after donor stem cell transplant.
      Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes
      needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have histologically documented relapsed or refractory disease, with a
             diagnosis of one of the following lymphoid malignancies: diffuse large B-cell
             lymphoma, peripheral T-cell lymphoma (any subtype); subjects must have received at
             least one prior systemic chemotherapy and must have either received an autologous stem
             cell transplant, refused or been deemed ineligible for an autologous stem cell
             transplant

          -  Subjects must be willing and able to have a fresh tumor biopsy prior to start of study
             treatment for research evaluations and cohort categorizing; Note: if insufficient
             fresh tissue is obtained to provide sub-classification for cohorts, then tissue
             material from a previous relapse biopsy and/or original diagnostic block may be
             requested to meet this criterion

          -  Subjects must have measurable lesions (at least one target lesion measuring 2 cm in
             diameter) by computerized tomography (CT) scan, and/or measurable lymphoma cutaneous
             lesions of any size

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Absolute neutrophil count (ANC) >= 1,000/mm^3

          -  Platelet count >= 75,000/mm^3

          -  Hemoglobin >= 8.0 g/dL

          -  Serum creatinine =< 2.0 g/dL or calculated creatinine clearance >= 60 mL/min
             (Cockcroft-Gault method)

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x
             institutional upper limit of normal (ULN) or =< 5 x ULN if liver involved by lymphoma

          -  Bilirubin < 2.0 x ULN unless subject has Gilbert's disease, low-grade hemolysis, or
             liver involvement with lymphoma

          -  At least 2 weeks since prior chemotherapy, biological therapy, radiation therapy,
             major surgery, other investigational, or anti-cancer therapy that is considered
             disease-directed and recovered from prior toxicities to grade 0-1 at least 2 weeks
             prior to investigational therapy

          -  Females will be either postmenopausal for at least 1 year or surgically sterile for at
             least 3 months; OR females of child-bearing potential must have a negative pregnancy
             test at screening and agree to take appropriate precautions to avoid pregnancy from
             screening until 3 months after their last dose of study medication

          -  Males must agree to take appropriate precautions to avoid fathering a child from
             screening until 3 months after their last dose of study medication

          -  Able to comprehend and willing to sign an informed consent form (ICF)

        Exclusion Criteria:

          -  History of or active central nervous system (CNS) malignancy

          -  Allogeneic stem cell transplant within the last 6 months, or active-graft-versus-host
             disease following allogeneic transplant, or subjects currently on immunosuppressive
             therapy following allogeneic transplant

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situation that would limit compliance with
             study requirements as judged by treating physician; subjects receiving antibiotics
             that are under control may be included in the study

          -  Pregnant or breastfeeding women

          -  Clinically symptomatic and uncontrolled cardiovascular disease

          -  History of myocardial infarction, severe/unstable angina, or symptomatic congestive
             heart failure, within the 6 months prior to study drug administration

          -  Current or recent history (< 21 days prior to start of treatment) of a clinically
             significant bacterial, viral, fungal, parasitic or mycobacterial infection

          -  History of other malignancy, with the exception of squamous cell carcinoma of the
             skin, basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or other
             malignancies that have been in remission for at least 3 years

          -  Presence of a malabsorption syndrome possibly affecting drug absorption (e.g., Crohn's
             disease or chronic pancreatitis)

          -  Any prior or concomitant use of another JAK inhibitor

          -  Known active hepatitis B or C, or human immunodeficiency virus (HIV) infection

          -  Subjects who, in the opinion of the investigator, are unable or unlikely to comply
             with the dosing schedule and study evaluations