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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02974647
Recruitment Status : Recruiting
First Posted : November 28, 2016
Last Update Posted : April 11, 2024
Sponsor:
Collaborators:
Cornell University
Dana-Farber Cancer Institute
Thomas Jefferson University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: Ruxolitinib Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Multicenter Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
Study Start Date : November 2016
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974647


Contacts
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Contact: Alison Moskowitz, MD 212-639-4839
Contact: Steven Horwitz, MD 212-639-3045

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02974647    
Other Study ID Numbers: 16-1542
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Keywords provided by Memorial Sloan Kettering Cancer Center:
Ruxolitinib
T or NK Cell
Relapsed
Refractory
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases