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.
Title
- Brief Title: Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
- Official Title: A Phase II Multicenter Study of Ruxolitinib in Patients With T or NK Cell Lymphoma That Has Either Come Back or Not Responded to Treatment
Clinical Trial IDs
- ORG STUDY ID:
16-1542
- NCT ID:
NCT02974647
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Ruxolitinib | | rel/ref PTCLtumors are known to contain mutations associ |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
rel/ref PTCLtumors are known to contain mutations associ | Experimental | Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study. | |
with rel/ref PTCL with functional evidence of JAK/STAT | Experimental | Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study. | |
with rel/ref PTCL who do not meet criteria for cohort 1 or 2. | Experimental | Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study. | |
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
- Age ≥ 18
- ECOG ≤ 2
- Measurable disease defined by:
- Lugano Classification for systemic lymphoma or
- Absolute atypical lymphocytes ≥ 1000 cells/μL for diseases characterized by
leukemic disease
- mSWAT > 0 or Sezary count ≥ 1000 cells/μL for CTCL
- Previous systemic anti-cancer therapy 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
ruxolitinib initiation. Topical steroids for CTCL are permitted.
- Patients must meet the following lab criteria:
- ANC ≥ 1.0/mm^3, platelets ≥ 100 x 10^9/L or ≥ 75 x 10^9/L (if related to
lymphoma), Hgb ≥ 8g/dL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN); ≤ 3 x ULN if due to
lymphoma involvement; AST and ALT ≤ 3 x ULN; ≤ 5 x ULN if due to lymphoma
involvement
- Creatinine clearance ≥ 30 mL/min
- 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.
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
- Concurrent use of other anti-cancer agents or treatments.
°Patients with more than one type of lymphoma may be enrolled after discussion with
the MSK Principal Investigator
- Known history of testing positive for human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome (AIDS) within 12 months prior to initiating study
treatment.
- 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).
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | disease control rate |
Time Frame: | 2 years |
Safety Issue: | |
Description: | defined as the combination of complete response (CR), partial response (PR) and stable disease (SD). The reason we use this definition instead of the more conventional partial/complete response rate is twofold. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
Trial Keywords
- Ruxolitinib
- T or NK Cell
- Relapsed
- Refractory
Last Updated
January 20, 2017