Back to resultsSintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
Primary Purpose
Extranodal NK/T-cell Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma focused on measuring extranodal NK/T-cell lymphoma, PD-1 blockade, decitabine, sintilimab, hypomethylation, epigenetics
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.
Sites / Locations
- Beijing Tongren HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment arm
Arm Description
Sintilimab,200mg,ivdrip,day1 Decitabine 10mg d1-5, ivdrip, repeated every 3 weeks.
Outcomes
Primary Outcome Measures
complete response rate
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Secondary Outcome Measures
overall response rate
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
1-year progression free survival rate
time from date of enrollment to date of disease progression, death of any reason, whichever comes first
1-year overall survival rate
time from date of enrollment to date death of any reason
Full Information
NCT ID
NCT04279379
First Posted
February 19, 2020
Last Updated
May 6, 2020
Sponsor
Beijing Tongren Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04279379
Brief Title
Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK/T-cell Lymphoma
Keywords
extranodal NK/T-cell lymphoma, PD-1 blockade, decitabine, sintilimab, hypomethylation, epigenetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
treatment with sintilimab and decitabine.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment arm
Arm Type
Experimental
Arm Description
Sintilimab,200mg,ivdrip,day1 Decitabine 10mg d1-5, ivdrip, repeated every 3 weeks.
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
anti-PD-1-antibody
Intervention Description
200mg d1,ivdrip, repeated every 3 weeks
Intervention Type
Drug
Intervention Name(s)
Decitabine
Other Intervention Name(s)
hypomethylating agents
Intervention Description
10mg d1-5, ivdrip,repeated every 3 weeks
Primary Outcome Measure Information:
Title
complete response rate
Description
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time Frame
24 weeks ±7 days
Secondary Outcome Measure Information:
Title
overall response rate
Description
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time Frame
24 weeks ±7 days
Title
1-year progression free survival rate
Description
time from date of enrollment to date of disease progression, death of any reason, whichever comes first
Time Frame
up to 1year after enrollment
Title
1-year overall survival rate
Description
time from date of enrollment to date death of any reason
Time Frame
up to 1year after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LIANG WANG, M.D.
Phone
+8615013009093
Email
wangliangtrhos@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jing-wen Wang, M.D.
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Wang, MD
Phone
+8615001108693
Email
wangliangtrhos@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
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