Tofacitinib Combined With Chidamide in R/R ENKTCL

Phase 2

• Conditions: Extranodal NK/T-cell Lymphoma
• Interventions: Drug: tofacitinib; Drug: chidamide

• Registration Number: NCT03598959
• Lead Sponsor: Sichuan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-24
• Last Update Submitted: 2018-07-24
• Study First Posted: 2018-07-26
• Last Update Posted: 2018-07-26
• Study Start: 2019-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

  5. 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.

6. Patients with a cQT longer than 500 ms

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	tofacitinib	Treated with tofacitinib and chidamide for 4 cycles.
Treatment	chidamide	Treated with tofacitinib and chidamide for 4 cycles.

Primary Outcome Measures

Name	Time	Method
2-year progression free survival	2 years after recruitment

Secondary Outcome Measures

Name	Time	Method
adverse events (AEs)	2 years after recruitment
complete remission	4 months after treatment
2-year overall survival	2 years after recruitment

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China