LymphomaPhase 2NCT02974647
Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
A Phase 2 study testing Ruxolitinib in people with Lymphoma, run by Memorial Sloan Kettering Cancer Center at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Ruxolitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2016to Nov 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alison Moskowitz, MD contact
Steven Horwitz, MD contact
10 sites in 1 country
United States10 sites, 6 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Alison Moskowitz, MD, 212-639-4839
- Active, not recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
- Active, not recruiting
Northwestern Medicine (Data collection and specimen analysis)
Chicago, Illinois, 60611
- Recruiting
Memorial Sloan Kettering Commack
Commack, New York, 11725
Alison Moskowitz, MD, 212-639-4839
- Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Alison Moskowitz, MD, 212-639-4839
- Active, not recruiting
University of Miami
Miami, Florida
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Alison Moskowitz, MD, 212-639-4839
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Alison Moskowitz, MD, 212-639-4839
Steven Horwitz, MD, 212-639-3045
- Active, not recruiting
Weill Cornell Medical College
New York, New York
- Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
Alison Moskowitz, MD, 212-639-4839
About this study
Official title: 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.
- Conditions
- Lymphoma
- Being tested
- Ruxolitinib
- Keywords
- Ruxolitinib, T or NK Cell, Relapsed, Refractory
- Medical subject headings
- Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
| Study group | Role | What they receive |
|---|---|---|
| rel/ref PTCLtumors are known to contain mutations associ | Experimental | 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. Receives: Drug: Ruxolitinib |
| with rel/ref PTCL with functional evidence of JAK/STAT | Experimental | 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. Receives: Drug: Ruxolitinib |
| with rel/ref PTCL who do not meet criteria for cohort 1 or 2. | Experimental | 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. Receives: Drug: Ruxolitinib |
| Rare sub-type expansion cohort: T-PLL and T-LGL & any T-Cell/NK Lymphoma with JAK fusion mutations. | Experimental | 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. Receives: Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cornell University, Dana-Farber Cancer Institute, Thomas Jefferson University
- Responsible party
- Sponsor
- Investigators
- Alison Moskowitz, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974647
- Sponsor's protocol ID
- 16-1542
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2016
- Last updated
- 23 Oct 2026
- Results posted
- No
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.
PubMed 34653242