Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
NCT ID: NCT02974647
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
83 participants
INTERVENTIONAL
2016-11-30
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Ruxolitinib
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.
Ruxolitinib
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.
Ruxolitinib
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.
Ruxolitinib
Interventions
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Ruxolitinib
Eligibility Criteria
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Inclusion Criteria
* Relapse or refractory disease after at least 1 systemic therapy except for T-PLL, LGL, or T-cell Lymphoproliferative diseases with JAK2 fusion.
* 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
Exclusion 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.
* 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).
18 Years
ALL
No
Sponsors
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Cornell University
OTHER
Dana-Farber Cancer Institute
OTHER
Thomas Jefferson University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Alison Moskowitz, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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University of Miami
Miami, Florida, United States
Northwestern Medicine (Data collection and specimen analysis)
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Alison Moskowitz, MD
Role: CONTACT
Steven Horwitz, MD
Role: CONTACT
Facility Contacts
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Alison Moskowitz, MD
Role: primary
Alison Moskowitz, MD
Role: primary
Alison Moskowitz, MD
Role: primary
Alison Moskowitz, MD
Role: primary
Alison Moskowitz, MD
Role: primary
Steven Horwitz, MD
Role: backup
Alison Moskowitz, MD
Role: primary
References
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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.
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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16-1542
Identifier Type: -
Identifier Source: org_study_id
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