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RecruitingInterventionalPhase 2

Phase II Multicenter Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma

NCT ID: NCT02974647Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-04-22

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.

Arms & interventions

  • DrugRuxolitinib

Outcome measures

Primary

  • disease control rate

    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.

    Time frame: 2 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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, 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 * 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 locations (10)

University of Miami

Miami, Florida

Active Not Recruiting

Northwestern Medicine (Data collection and specimen analysis)

Chicago, Illinois, 60611

Active Not Recruiting

Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Active Not Recruiting

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

Recruiting
Alison Moskowitz, MD · Contact

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

Recruiting
Alison Moskowitz, MD · Contact

Memorial Sloan Kettering Commack

Commack, New York, 11725

Recruiting
Alison Moskowitz, MD · Contact

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

Recruiting
Alison Moskowitz, MD · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting
Alison Moskowitz, MD · Contact
Steven Horwitz, MD · Contact
Allison Moskowitz, MD · Principal Investigator

Weill Cornell Medical College

New York, New York

Active Not Recruiting

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553

Recruiting
Alison Moskowitz, MD · Contact

References

  • 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.(PubMed)