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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treated with tofacitinib and chidamide for 4 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tofacitinib | Drug | orally 10 mg daily |
| |
| chidamide |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year progression free survival | 2 years after recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| complete remission | 4 months after treatment | |
| adverse events (AEs) | 2 years after recruitment | |
| 2-year overall survival |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Ji, MD | Contact | 86-28-85422373 | jieji@scu.edu.cn | |
| Ting Niu, MD | Contact | 86-28-85422373 | tingniu@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25980440 | Background | Lee 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. |
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| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
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| Drug |
orally 20 mg twice weekly |
|
| 2 years after recruitment |
| D009369 |
| Neoplasms |