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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04917250
Other study ID # TRhos-ENKTCL-7
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 20, 2020
Est. completion date August 31, 2021

Study information

Verified date June 2021
Source Beijing Tongren Hospital
Contact Liang Wang, M.D.
Phone +861058268442
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 GPED (gemcitabine, pegaspargase, etoposide, and dexamethasone) regimen in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date August 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 16 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:
Gemcitabine
1000mg/?,d1,4 ivdrip
Pegaspargase
2500IU/?, maximum dose less than 3750IU
Etoposide
100mg/?,d1-3 ivdrip
Dexamethasone
20mg/d d1-4 ivdrip

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 overall response rate evaluated by PET-CT and MRI, according to Lugano 2014 criteria 24 weeks ±7 days
Secondary complete 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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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
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Completed NCT03493451 - Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms Phase 2
Recruiting NCT04279379 - Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma 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)