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Induction Chemotherapy Sequential Sintilimab Combined With Dual Epigenetic Drugs for ENKTL-HLH

NCT05008666 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-08-17

No results posted yet for this study

Summary

ENKTL is a highly aggressive non-Hodgkin lymphoma closely related to EBV infection，and advanced patients often suffer from hemophagocytic lymphohistiocytosis (HLH). ENKTL-HLH lacks standard treatment and experiences a extremely poor prognosis. Anti-PD-1 antibody has shown good anti-tumor activity in ENKTL and play a potential role in EBV-HLH. Epigenetic drugs have been confirmed to exert synergistic anti-tumor activity with anti-PD-1 antibody. We next further explore the efficacy and safety of Sintilimab sequential combination of epigenetic drugs in ENKTL-HLH.

Conditions

  • Safety and Efficacy

Interventions

DRUG

Sintilimab

1. To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 2. To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 3. Exploring biomarkers that may have predictive effects.

DRUG

Chidamide

1. To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 2. To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 3. Exploring biomarkers that may have predictive effects.

DRUG

Azacitidine

1. To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 2. To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients. 3. Exploring biomarkers that may have predictive effects.

DRUG

L-DEP

L-DEP

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-11-30
Completion
2023-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05008666 on ClinicalTrials.gov