Phase II Multicenter Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma

Protocol # :
Disease Sites
Other Hematopoietic
Non-Hodgkin's Lymphoma
Principal Investigator
Jacobsen, Eric
Site Research Nurses
Brennan, Lisa
Chung, Anita
Davis, Jaynie
Harran, John
Kilcommons, Marykate
Liao, Zixi
Normilus, Samantha
Waisgerber, Susan, M.

Trial Description

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 Requirements

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/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.

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).