study of ruxolitinib in relapsed or refractory t or nk cell lymphoma

Conditions: Lymphoma

Summary: the purpose of this study is to test any good and bad effects of the study drug called ruxolitinib. ruxolitinib works by blocking a protein called jak. jak works along with another protein called stat and is important for survival of many t or nk-cell lymphomas. by blocking jak, ruxolitinib may cause t or nk-cell lymphomas to shrink.


Eligibility criteria:
inclusion criteria: * pathologically confirmed t or nk cell lymphoma at the enrolling institution. for ctcl, patients with stage ib disease or greater are eligible. * relapse or refractory disease after at least 1 systemic therapy except for t-pll, lgl, or t-cell lymphoproliferative diseases with jak2 fusion. * untreated patients may be allowed after discussion with p.i. * age ≥ 18 * ecog ≤ 2 * measurable disease defined by: * lugano classification for systemic lymphoma or * atypical and or malignant lymphocytes quantifiable by flow cytometry or morphology in blood or bone marrow or * mswat \> 0 or sezary count ≥ 1000 cells/μl for ctcl * previous systemic anti-cancer therapy for t-cell lymphoma must have been discontinued at least 2 weeks prior to treatment. * glucocorticoids aimed at controlling lymphoma-related symptoms are allowed as long as they are tapered down to 20mg or less by the time of ruxolitiib initiation * topical steroids for ctcl are permitted * see section 6.2 subject exclusion criteria for guideline regarding adjuvant and maintenance therapy for prior malignancy * patients must meet the following lab criteria: * anc ≥ 1.0/mm\^3 or anc \>/= 0.5/mm\^3 (if patient has baseline neutropenia due to lymphoma), platelets ≥ 100 x 10\^9/l or ≥ 50 x 10\^9/l (if related to lymphoma), hgb ≥ 8g/dl * patients with lgl or t-pll are not required to meet a minimum anc or hemoglobin value for eligibility * total bilirubin ≤ 1.5 x upper limit of normal (uln) or; ≤ 3 x uln if documented hepatic involvement with lymphoma, or ≤ 5 x uln if history of gilbert's ; ast and alt ≤ 3 x uln; ≤ 5 x uln if due to lymphoma involvement * creatinine clearance ≥ 30 ml/min; creatinine clearance of 15-29 ml/min will be allowed as long as baseline platelets are ≥ 150 x 10\^9/l * for patients with positive hepatitis b core antibody or surface antigen, hepatitis b pcr must be negative and prophylaxis with entecavir or equivalent is required. * patients with hiv are allowed provided that they are on anti-retroviral treatment with no active infections. exclusion criteria: * any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * uncontrolled concurrent illness including, but not limited to, ongoing or active infection, uncontrolled diabetes, clinically significant pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * ecog performance status \>2 * prior therapy with ruxolitinib * receiving systemic therapy for another primary malignancy (other than t-cell lymphoma) * patients with more than one type of lymphoma may be enrolled after discussion with the msk principal investigator * adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than t-cell lymphoma) is permissible after discussion with the msk principal investigator * women of reproductive potential† must have a negative serum ß human chorionic gonadotropin (ß-hcg) pregnancy test. * a female of reproductive potential is a sexually mature female who: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e. has had menses at any time in the preceding 24 consecutive months).

Keywords: ruxolitinib t or nk cell relapsed refractory