Last updated on June 2019

Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphoma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 where 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/L 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, 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
  • 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 human chorionic gonadotropin (-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).

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.