Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma
Recruiting
Phase 2Interventional Study
Lymphoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
83 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for adults with specific types of lymphoma that have either returned or did not respond to prior treatment. Participants will take a drug called ruxolitinib to see if it helps reduce the size of their lymphoma.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with T or NK cell lymphoma.
I have had at least one prior treatment for my lymphoma.
I can measure my disease with specific testing.
I am in decent health and can manage daily activities.
My previous anti-cancer treatments were stopped at least 2 weeks ago.
My blood tests meet certain criteria.
If I have hepatitis B or HIV, I am being treated.
You may not be able to join if
I have a serious medical condition that prevents me from joining.
I have an uncontrolled illness like an active infection or significant heart issues.
My health status is worse than a specific level.
I have previously taken ruxolitinib.
I am currently being treated for a different type of cancer.
I am pregnant or have not had a pregnancy test done.
I have had mental health issues affecting my ability to participate.
I have an infection that needs treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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City
State
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Status
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 J…
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).
Contacts
Alison Moskowitz, MD
212-639-4839
CONTACT
Steven Horwitz, MD
212-639-3045
CONTACT
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