Tofacitinib Combined With Chidamide in R/R ENKTCL

Sichuan University

Status and phase

Unknown

Phase 2

Conditions

Extranodal NK/T-cell Lymphoma

Treatments

Drug: chidamide

Drug: tofacitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT03598959

HXNKT 2.0

Details and patient eligibility

About

This study is to explore the efficacy and safety of tofacitinib combined with chidamide in patients with relapsed and refractory extranodal NK/T cell lymphoma.

Enrollment

20 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Patients with primary refractory or recurrent extranodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
2. Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine </= 1.8 mg/dL.
3. Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) </= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase </= 2 x upper limit of normal.
4.. Adequate cardiac function with left ventricular ejection fraction >/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
1. Performance status 0-1. 6. Negative Beta diffusing capacity of lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization

Exclusion criteria

-1. Patients relapsed after allogeneic stem cell transplant 2. Patients with active hepatitis B or C(HBV DNA >/=10,000 copies/mL). 3. Active infection requiring parenteral antibiotics 4. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts 5. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.