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

NCT04279379 | Unknown Phase 2

• 1 other identifier: TRhos-ENKTCL-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Extranodal NK/T-cell Lymphoma

Keywords

extranodal NK/T-cell lymphoma; PD-1 blockade; decitabine; sintilimab; hypomethylation; epigenetics

Outcome Measures

Primary Outcomes (1)

• complete response rate

  evaluated by PET-CT and MRI, according to Lugano 2014 criteria

  24 weeks ±7 days

Secondary Outcomes (3)

• overall response rate

  24 weeks ±7 days

• 1-year progression free survival rate

  up to 1year after enrollment

• 1-year overall survival rate

  up to 1year after enrollment

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Drug: Sintilimab; Drug: Decitabine

Interventions

Sintilimab DRUG

200mg d1,ivdrip, repeated every 3 weeks

Also known as: anti-PD-1-antibody

treatment arm

Decitabine DRUG

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

Also known as: hypomethylating agents

treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

sintilimab; spartalizumab; Decitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jing-wen Wang, M.D.

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LIANG WANG, M.D.

CONTACT

+8615013009093; wangliangtrhos@126.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: Director of department of hematology

Model Details: treatment with sintilimab and decitabine.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: April 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)