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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04279379
Other study ID # TRhos-ENKTCL-2
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
See also
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Recruiting NCT04917250 - GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma Phase 2
Recruiting NCT06406556 - Safety & Efficacy of Peg-ASP-based CCRT in Early Stage ENKTL Phase 2
Not yet recruiting NCT04337593 - Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL Phase 2
Active, not recruiting NCT04414163 - A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type Phase 2
Not yet recruiting NCT05700448 - Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma Phase 3
Completed NCT03246750 - B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma Phase 1/Phase 2
Not yet recruiting NCT03598959 - Tofacitinib Combined With Chidamide in R/R ENKTCL Phase 2
Recruiting NCT00725231 - Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP Phase 3
Recruiting NCT04554511 - Prognostic Nomogram of Extranodal NK/T-cell Lymphoma
Recruiting NCT03671850 - VT-EBV-N for Treatment of Severe in EBV Positive Extranodal NK/T Cell Lymphoma Patients Phase 2
Completed NCT03493451 - Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms Phase 2
No longer available NCT05131438 - An Expanded Access Program to Provide Sugemalimab for the Treatment of Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (R/R ENKTL)