Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

Extranodal NK/T-cell Lymphoma Clinical Trial

Official title:

Combination of Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04279379
• Other study ID #: TRhos-ENKTCL-2
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2020
• Source: Beijing Tongren Hospital
• Contact: LIANG WANG, M.D.
• Phone: +8615013009093
• Email: wangliangtrhos[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with decitabine in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients

Description:

Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). However, the CR rate of PD-1 antibody monotherapy is too low. Previous studies have demonstrated that decitabine may activate the T cells and enhance the efficacy of PD-1 antibodies in Hodgkin Lymphoma. Thus, the investigators aim to evaluate the efficacy and safety of sintilimab in combination with decitabine in the treatment of NK/T cell lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.

• refractory or relapsed after initial remission, or stage III-IV de novo patients

• PET/CT or CT/MRI with at least one objectively evaluable lesion.

• General status ECOG score 0-3 points.

• The laboratory test within 1 week before enrollment meets the following conditions:

Blood routine: Hb>80g/L, PLT>50×10e9/L. Liver function: ALT, AST, TBIL =2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF=50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.

• Sign the informed consent form

Exclusion Criteria:

Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.

Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.

Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.

• Other experimental drugs are being used.

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• Sintilimab
200mg d1,ivdrip, repeated every 3 weeks
• Decitabine
10mg d1-5, ivdrip,repeated every 3 weeks

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete response rate	evaluated by PET-CT and MRI, according to Lugano 2014 criteria	24 weeks ±7 days
Secondary	overall response rate	evaluated by PET-CT and MRI, according to Lugano 2014 criteria	24 weeks ±7 days
Secondary	1-year progression free survival rate	time from date of enrollment to date of disease progression, death of any reason, whichever comes first	up to 1year after enrollment
Secondary	1-year overall survival rate	time from date of enrollment to date death of any reason	up to 1year after enrollment