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

April 10, 2024 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Steven Horwitz, MD
  • Phone Number: 212-639-3045

Study Contact Backup

  • Name: Alison Moskowitz, MD
  • Phone Number: 212-639-4839

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States
        • Active, not recruiting
        • University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Medicine (Data collection and specimen analysis)
        • Contact:
          • Jaehyuk Choi, MD, PhD
          • Phone Number: 312-695-8106
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Active, not recruiting
        • Dana Farber Cancer Institute
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Alison Moskowitz, MD
          • Phone Number: 212-639-4839
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All Protocol Activities)
        • Contact:
          • Alison Moskowitz, MD
          • Phone Number: 212-639-4839
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Alison Moskowitz, MD
          • Phone Number: 212-639-4839
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Alison Moskowitz, MD
          • Phone Number: 212-639-4839
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Steven Horwitz, MD
          • Phone Number: 212-639-3045
        • Principal Investigator:
          • Allison Moskowitz, MD
        • Contact:
          • Alison Moskowitz, MD
          • Phone Number: 212-639-4839
      • New York, New York, United States
        • Active, not recruiting
        • Weill Cornell Medical College
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All Protocol Activities)
        • Contact:
          • Alison Moskowitz, MD
          • Phone Number: 212-639-4839

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rel/ref PTCLtumors are known to contain mutations associ
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
Drug: Ruxolitinib
Experimental: with rel/ref PTCL with functional evidence of JAK/STAT
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours). Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
Drug: Ruxolitinib
Experimental: with rel/ref PTCL who do not meet criteria for cohort 1 or 2.
Patients will receive ruxolitinib 20mg BID orally on 28 day cycles. Ruxolitinib should be taken by mouth every 12 hours approximately the same time each day (+/- 2 hours).Treatment may continue until disease progression, unacceptable toxicity, recommended termination by the treating physician, or termination of the study.
Drug: Ruxolitinib
Experimental: Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations.
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.
Drug: Ruxolitinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease control rate
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Dana-Farber Cancer Institute
Thomas Jefferson University
Cornell University

Investigators

  • Principal Investigator: Alison Moskowitz, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 25, 2016

First Posted (Estimated)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 10, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-1542

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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