Status:
UNKNOWN
GPED Regimen for Relapsed/Refractory or Advanced ENKTCL
Lead Sponsor:
Beijing Tongren Hospital
Conditions:
Extranodal NK/T-cell Lymphoma, Nasal Type
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphom...
Detailed Description
Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sys...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Key Trial Info
Start Date :
March 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2023
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT04405375
Start Date
March 21 2020
End Date
April 30 2023
Last Update
May 28 2020
Active Locations (1)
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1
Beijing Tongren Hospital
Beijing, China, 100730