Clinical Trials /

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

NCT02974647

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.

Related Conditions:
  • Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

  • Lymphoma

Interventions

DrugSynonymsArms
Ruxolitinibrel/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

NameTypeDescriptionInterventions
rel/ref PTCLtumors are known to contain mutations associExperimentalPatients 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.
  • Ruxolitinib
with rel/ref PTCL with functional evidence of JAK/STATExperimentalPatients 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.
  • Ruxolitinib
with rel/ref PTCL who do not meet criteria for cohort 1 or 2.ExperimentalPatients 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.
  • Ruxolitinib

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