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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02974647
• Other study ID #: 16-1542
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2016
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Alison Moskowitz, MD
• Phone: 212-639-4839
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. By blocking JAK, ruxolitinib may cause T or NK-cell lymphomas to shrink.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 where 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).

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Ruxolitinib

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Cornell University, Dana-Farber Cancer Institute, Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center