We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : October 7, 2022
Sponsor:
Collaborators:
Cornell University
Dana-Farber Cancer Institute
Thomas Jefferson University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE November 23, 2016
First Posted Date  ICMJE November 28, 2016
Last Update Posted Date October 7, 2022
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
Official Title  ICMJE Phase II Multicenter Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE Drug: Ruxolitinib
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: Ruxolitinib
  • Experimental: Rare sub-type expansion cohort: T-PLL and T-LGL and non-MF CTCL 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.
    Intervention: Drug: Ruxolitinib
Publications * Moskowitz AJ, Ghione P, Jacobsen E, Ruan J, Schatz JH, Noor S, Myskowski P, Vardhana S, Ganesan N, Hancock H, Davey T, Perez L, Ryu S, Santarosa A, Dowd J, Obadi O, Pomerantz L, Yi N, Sohail S, Galasso N, Neuman R, Liotta B, Blouin W, Baik J, Geyer MB, Noy A, Straus D, Kumar P, Dogan A, Hollmann T, Drill E, Rademaker J, Schoder H, Inghirami G, Weinstock DM, Horwitz SM. A phase 2 biomarker-driven study of ruxolitinib demonstrates effectiveness of JAK/STAT targeting in T-cell lymphomas. Blood. 2021 Dec 30;138(26):2828-2837. doi: 10.1182/blood.2021013379.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2021)
82
Original Estimated Enrollment  ICMJE
 (submitted: November 25, 2016)
52
Estimated Study Completion Date  ICMJE November 2024
Estimated Primary Completion Date November 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alison Moskowitz, MD 212-639-4839
Contact: Steven Horwitz, MD 212-639-3045
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02974647
Other Study ID Numbers  ICMJE 16-1542
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Memorial Sloan Kettering Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Cornell University
  • Dana-Farber Cancer Institute
  • Thomas Jefferson University
Investigators  ICMJE
Principal Investigator: Alison Moskowitz, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP