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Tofacitinib Combined With Chidamide in R/R ENKTCL

Primary Purpose

Extranodal NK/T-cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

tofacitinib

chidamide

About this trial

This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.
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

Sites / Locations

West China Hospital of Sichuan University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treated with tofacitinib and chidamide for 4 cycles.

Outcomes

Primary Outcome Measures

2-year progression free survival

Secondary Outcome Measures

complete remission

adverse events (AEs)

2-year overall survival

Full Information

NCT ID

NCT03598959

First Posted

July 16, 2018

Last Updated

July 24, 2018

Sponsor

Sichuan University

1. Study Identification

Unique Protocol Identification Number

NCT03598959

Brief Title

Tofacitinib Combined With Chidamide in R/R ENKTCL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2019 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sichuan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Extranodal NK/T-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Treated with tofacitinib and chidamide for 4 cycles.

Intervention Type

Drug

Intervention Name(s)

tofacitinib

Intervention Description

orally 10 mg daily

Intervention Type

Drug

Intervention Name(s)

chidamide

Intervention Description

orally 20 mg twice weekly

Primary Outcome Measure Information:

Title

2-year progression free survival

Time Frame

2 years after recruitment

Secondary Outcome Measure Information:

Title

complete remission

Time Frame

4 months after treatment

Title

adverse events (AEs)

Time Frame

2 years after recruitment

Title

2-year overall survival

Time Frame

2 years after recruitment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Ji, MD

Phone

86-28-85422373

jieji@scu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Ting Niu, MD

Phone

86-28-85422373

tingniu@sina.com

Facility Information:

Facility Name

West China Hospital of Sichuan University

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610044

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25980440

Citation

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.

Results Reference

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Tofacitinib Combined With Chidamide in R/R ENKTCL

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