Clinical trial NCT04405375: GPED Regimen for Relapsed/Refractory or Advanced ENKTCL
Official title: Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Keywords: extranodal NK/T-cell lymphoma
gemcitabine
etoposide
dexamethasone
pegaspargase
hemophagocytic syndrome
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 lymphoma patients (ENKTCL).

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 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.

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.
* 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.

Primary outcomes:
measure: 2-year progression free survival (PFS) rate
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
measure: Complete response rate (CRR)
timeFrame: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
measure: 2-year overall survial (OS) rate
timeFrame: From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
Study officials:
References: