Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma (NCT02974647) | Clinical Trial Compass
RecruitingPhase 2
Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
United States83 participantsStarted 2016-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (UL…