GPED Regimen for Relapsed/Refractory or Advanced ENKTCL

  • STATUS
    Recruiting
  • participants needed
    29
  • sponsor
    Beijing Tongren Hospital
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Updated on 16 February 2024
See if I qualify
remission
dexamethasone
renal function
gemcitabine
lymphoma
etoposide
pegaspargase
immunohistochemistry
PET-CT
myocardial infarction
arrhythmia
renal function tests
pet/ct scan
renal function test
pet-ct scan
acute myocardial infarction
t-cell lymphoma
extranodal nk/t-cell lymphoma, nasal type
lymphoma, extranodal nk-t-cell

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 lymphoma patients (ENKTCL).

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 sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these patients.

Details
Condition Angiocentric T-cell lymphoma
Age 18years - 75years
Treatment Etoposide, Dexamethasone, gemcitabin, Pegaspargase
Clinical Study IdentifierNCT04405375
SponsorBeijing Tongren Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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>5010e9/L
Liver function: ALT, AST, TBIL 2 times the upper limit of normal
Renal function: Cr is normal
Cardiac function: LVEF50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking
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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
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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remission
dexamethasone
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immunohistochemistry
PET-CT
myocardial infarction
arrhythmia
renal function tests
pet/ct scan
renal function test
pet-ct scan
acute myocardial infarction
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extranodal nk/t-cell lymphoma, nasal type
lymphoma, extranodal nk-t-cell

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