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

Part of paid clinical trials in Miami, Florida.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT02974647
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 30, 2016
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
83 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

disease control rate [ Time Frame: 2 years ]

Central Contacts

  • Alison Moskowitz, MD
    212-639-4839
  • Steven Horwitz, MD
    212-639-3045

Locations (10)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida--
Northwestern Medicine (Data collection and specimen analysis)ChicagoIllinois60611-
Dana Farber Cancer InstituteBostonMassachusetts02115-
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920
Alison Moskowitz, MD
212-639-4839
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Alison Moskowitz, MD
212-639-4839
Memorial Sloan Kettering CommackCommackNew York11725
Alison Moskowitz, MD
212-639-4839
Memorial Sloan Kettering WestchesterHarrisonNew York10604
Alison Moskowitz, MD
212-639-4839
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alison Moskowitz, MD
212-639-4839
Steven Horwitz, MD
212-639-3045
Allison Moskowitz, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell Medical CollegeNew YorkNew York--
Memorial Sloan Kettering Nassau (All Protocol Activities)UniondaleNew York11553
Alison Moskowitz, MD
212-639-4839

Find similar trials in Miami, FL

By research site
University of Miami· Miami, FLNorthwestern Medicine (Data collection and specimen analysis)· Chicago, ILDana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Commack· Commack, NY

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