Testing ruxolitinib for relapsed or refractory T or NK cell lymphoma

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

This study is testing if the drug ruxolitinib can help people with T or NK cell lymphoma that hasn't responded to other treatments by shrinking their tumors and improving their health.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 83 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (other)
• Drugs / interventions: ruxolitinib
• Locations: 10 sites (Miami, Florida and 9 other locations)
• Trial ID: NCT02974647 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of ruxolitinib, a drug that inhibits the JAK protein, on patients with relapsed or refractory T or NK cell lymphoma. The trial aims to determine both the positive and negative impacts of the drug on tumor size and patient health. Eligible participants must have a confirmed diagnosis of T or NK cell lymphoma and have previously undergone at least one systemic therapy. The study will assess the drug's efficacy in shrinking lymphomas and improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed T or NK cell lymphoma that has relapsed or is refractory after prior treatment.

Not a fit: Patients with untreated T or NK cell lymphoma or those with specific types of T-cell lymphoproliferative diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat lymphomas.

How similar studies have performed: Other studies have shown promising results with JAK inhibitors in similar conditions, indicating potential for success in this approach.

Eligibility criteria

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).

Where this trial is running

Miami, Florida and 9 other locations

• University of Miami — Miami, Florida, United States (ACTIVE_NOT_RECRUITING)
• Northwestern Medicine (Data collection and specimen analysis) — Chicago, Illinois, United States (ACTIVE_NOT_RECRUITING)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (ACTIVE_NOT_RECRUITING)
• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States (RECRUITING)
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (RECRUITING)
• Memorial Sloan Kettering Commack — Commack, New York, United States (RECRUITING)
• Memorial Sloan Kettering Westchester — Harrison, New York, United States (RECRUITING)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
• Weill Cornell Medical College — New York, New York, United States (ACTIVE_NOT_RECRUITING)
• Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Alison Moskowitz, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Alison Moskowitz, MD

Conditions: Lymphoma, Ruxolitinib, T or NK Cell, Relapsed, Refractory