GPED Regimen for Relapsed/Refractory or Advanced ENKTCL

Phase 2

• Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
• Interventions: Drug: gemcitabin; Drug: Pegaspargase; Drug: Etoposide; Drug: Dexamethasone

• Registration Number: NCT04405375
• Lead Sponsor: Beijing Tongren Hospital

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.

Study Timeline

• Study Start: 2020-03-21
• Status Verified: 2020-05
• Study First Submitted: 2020-05-24
• Study First Submitted QC: 2020-05-24
• Last Update Submitted: 2020-05-24
• Study First Posted: 2020-05-28
• Last Update Posted: 2020-05-28
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment arm	Dexamethasone	gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =\<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
treatment arm	gemcitabin	gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =\<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
treatment arm	Pegaspargase	gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =\<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
treatment arm	Etoposide	gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =\<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.

Primary Outcome Measures

Name	Time	Method
2-year progression free survival (PFS) rate	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	PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	evaluated every 2 cycles of treamtent, up to one month after the end of treatment	evaluated by PET-CT and MRI, according to Lugano 2014 criteria
2-year overall survial (OS) rate	From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months	OS is defined as date of enrollment to date of death of any reason, or last follow-up, whichever comes first.
Complete response rate (CRR)	evaluated every 2 cycles of treamtent, up to one month after the end of treatment	evaluated by PET-CT and MRI, according to Lugano 2014 criteria

Trial Locations

Locations (1)

Beijing Tongren Hospital; 🇨🇳 Beijing, China