Clinical trial · Interventional
Tofacitinib Combined With Chidamide in R/R ENKTCL
Phase I/II Study of Safety and Efficacy of Tofacitinib Combined With Chidamide in Patients With Relapsed and Refractory Extranodal Natural Killer/T Cell Lymphoma
NCT03598959CI-TRIAL-00033986unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK/T-cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chidamide | Drug | — | UNRESOLVED |
| tofacitinib | Drug | Tofacitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Treated with tofacitinib and chidamide for 4 cycles.
- interventionNames
- Drug: tofacitinib
- Drug: chidamide
Primary outcomes (1)
- measure
- 2-year progression free survival
- timeFrame
- 2 years after recruitment
Secondary outcomes (3)
- measure
- complete remission
- timeFrame
- 4 months after treatment
- measure
- adverse events (AEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDLee S, Park HY, Kang SY, Kim SJ, Hwang J, Lee S, Kwak SH, Park KS, Yoo HY, Kim WS, Kim JI, Ko YH. Genetic alterations of JAK/STAT cascade and histone modification in extranodal NK/T-cell lymphoma nasal type. Oncotarget. 2015 Jul 10;6(19):17764-76. doi: 10.18632/oncotarget.3776. PMID 25980440