Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03598959
Other study ID # HXNKT 2.0
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2021

Study information

Verified date July 2018
Source Sichuan University
Contact Jie Ji, MD
Phone 86-28-85422373
Email jieji@scu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date December 31, 2021
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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


Intervention

Drug:
tofacitinib
orally 10 mg daily
chidamide
orally 20 mg twice weekly

Locations

Country Name City State
China West China Hospital of Sichuan University Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 2-year progression free survival 2 years after recruitment
Secondary complete remission 4 months after treatment
Secondary adverse events (AEs) 2 years after recruitment
Secondary 2-year overall survival 2 years after recruitment
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Recruiting NCT05377827 - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies Phase 1
Recruiting NCT04917250 - GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma Phase 2
Recruiting NCT06406556 - Safety & Efficacy of Peg-ASP-based CCRT in Early Stage ENKTL Phase 2
Not yet recruiting NCT04337593 - Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL Phase 2
Active, not recruiting NCT04414163 - A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type Phase 2
Not yet recruiting NCT05700448 - Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma Phase 3
Completed NCT03246750 - B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma Phase 1/Phase 2
Recruiting NCT00725231 - Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP Phase 3
Recruiting NCT04554511 - Prognostic Nomogram of Extranodal NK/T-cell Lymphoma
Recruiting NCT03671850 - VT-EBV-N for Treatment of Severe in EBV Positive Extranodal NK/T Cell Lymphoma Patients Phase 2
Completed NCT03493451 - Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms Phase 2
Recruiting NCT04279379 - Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma Phase 2
No longer available NCT05131438 - An Expanded Access Program to Provide Sugemalimab for the Treatment of Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (R/R ENKTL)