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

NCT ID: NCT04279379

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2022-12-31

Brief 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

Detailed 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.

Conditions

Extranodal NK/T-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

Sintilimab,200mg,ivdrip,day1 Decitabine 10mg d1-5, ivdrip, repeated every 3 weeks.

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

200mg d1,ivdrip, repeated every 3 weeks

Decitabine

Intervention Type: DRUG

10mg d1-5, ivdrip,repeated every 3 weeks

Interventions

Sintilimab

200mg d1,ivdrip, repeated every 3 weeks

Intervention Type: DRUG

Decitabine

10mg d1-5, ivdrip,repeated every 3 weeks

Intervention Type: DRUG

Other Intervention Names

anti-PD-1-antibody; hypomethylating agents

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

JING-WEN WANG

Director of department of hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing-wen Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tongren Hospital

Locations

Beijing Tongren Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

LIANG WANG, M.D.

Role: CONTACT

wangliangtrhos@126.com

+8615013009093

Facility Contacts

Liang Wang, MD

Role: primary

wangliangtrhos@126.com

+8615001108693

Other Identifiers

TRhos-ENKTCL-2

Identifier Type: -

Identifier Source: org_study_id