Tofacitinib Combined With Chidamide in R/R ENKTCL

NCT03598959 | Unknown Phase 2

• 1 other identifier: HXNKT 2.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Extranodal NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• 2-year progression free survival

  2 years after recruitment

Secondary Outcomes (3)

• complete remission

  4 months after treatment

• adverse events (AEs)

  2 years after recruitment

• 2-year overall survival

  2 years after recruitment

Study Arms (1)

Treatment

EXPERIMENTAL

Treated with tofacitinib and chidamide for 4 cycles.

Drug: tofacitinib; Drug: chidamide

Interventions

tofacitinib DRUG

orally 10 mg daily

Treatment

chidamide DRUG

orally 20 mg twice weekly

Treatment

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with primary refractory or recurrent extranodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.
• \. Adequate renal function, as defined by estimated serum creatinine clearance \>/=50 ml/min and/or serum creatinine \</= 1.8 mg/dL.
• \. 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.
• Adequate cardiac function with left ventricular ejection fraction \>/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.
• \. 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

You may not qualify if:

• 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.
• \. Patients with a cQT longer than 500 ms

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

Related Publications (1)

• 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.

  PMID: 25980440 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

tofacitinib; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Jie Ji, MD

CONTACT

86-28-85422373; jieji@scu.edu.cn

Ting Niu, MD

CONTACT

86-28-85422373; tingniu@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2021
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

CN (1)