Phase II Multicenter Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
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.
- 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/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
- 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.
- 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).